| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Example Drug Treatment for example condition requiring FDA review | Phase 3 | -% | Small Molecule | Oncology | ||
PDUFA 2026 | Example Drug Treatment for example condition requiring FDA review | Phase 3 | -% | Small Molecule | Oncology | ||
PDUFA 2026 | Example Drug Treatment for example condition requiring FDA review | Phase 3 | -% | Small Molecule | Oncology |
Recent Updates
Recently added Catalysts
Arcutis Biotherapeutics, Inc.$25.81
-0.03 (-0.12%)
B 77Pipeline Score Undervalued Pharma · Commercial
Market Cap
2.60 B
EPS
-0.02
P/E Ratio
-1,111.76 $
Value Trade
22.59 M
SEC Financials
Q1 2026Dilution Risk
Revenue
105.40 M
R&D Expenses
30.63 M
Operating CF
2.24 M
Total Assets
460.00 M
Total Liabilities
270.36 M
Equity
189.65 M
D/E Ratio
12,345
-1.28 %
Week
-11.61 %
1 Month
-24.8 %
3 Month
-23.17 %
6 Month
-17.91 %
5 Year
-9.5 %
All Time
Cash Data
Cash Position
224.00 M
Monthly Burn
-
Runway
12,345 mo
Burn Trend
SEC Filing
May 6, 2026
Overview
Volume
1.20 M
52 Week Range
12.72 - 31.77
% held by Insiders
11.75 %
% held by Institutions
98.4 %
Enterprise Value
2.49 B
Total Shares
122.44 M
Short %
14.47 %
Float Shares
109.34 M
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for Arcutis Biotherapeutics, Inc.
567Total events
5Upcoming
212Tier-1 (high impact)
2020 – 2027Coverage
Upcoming catalysts 5
Q1 2027
T1Topline Readout
Phase 2 proof-of-concept results for ZORYVE foam 0.3% in hidradenitis suppurativa expected
Event history 562
Q3 2026
●sNDA SubmissionZORYVEApprovedRegulatory Filing
sNDA submission for ZORYVE cream 0.05% in infants
atopic dermatitis in infants 3-24 monthssource ↗
Jun 29, 2026
◆PDUFA DateZORYVEApprovedRegulatory Filing
PDUFA target action date for ZORYVE cream 0.3% sNDA for plaque psoriasis in children ages 2-5
plaque psoriasis in children ages 2-5source ↗
Jun 9, 2026
◆Oral PresentationPresentation
Arcutis management to present at Goldman Sachs 47th Annual Global Healthcare Conference
May 6, 2026
May 6, 2026
●sNDA SubmissionZORYVEApprovedRegulatory Filing
sNDA submitted for ZORYVE cream 0.05% for atopic dermatitis in infants 3-24 months
atopic dermatitissource ↗
May 6, 2026
▲Enrollment CompleteZORYVEApprovedTrial
Enrollment completed in ZORYVE foam 0.3% MUSE trial in children ages 2-11
plaque psoriasissource ↗
May 6, 2026
▲Trial InitiationARQ-234Trial
Phase 1a/1b first-in-human study initiated for ARQ-234
atopic dermatitissource ↗
May 6, 2026
▲Oral PresentationZORYVEApprovedPresentation
Late-breaking presentation of INTEGUMENT-INFANT Phase 2 trial results at AAD 2026
atopic dermatitissource ↗
May 6, 2026
●Milestone PaymentARQ-234Corporate
$10M milestone payment triggered by first patient dosed in ARQ-234 trial
Apr 27, 2026
◆sNDA SubmissionZORYVEApprovedRegulatory Filing
sNDA submission to FDA for ZORYVE cream 0.05% to expand indication to infants down to 3 months with mild to moderate atopic dermatitis
atopic dermatitissource ↗
Apr 27, 2026
▲Topline ReadoutZORYVEApprovedClinical Data
Positive topline results from INTEGUMENT-INFANT Phase 2 open-label study in infants aged 3 months to less than 24 months
atopic dermatitissource ↗
Apr 27, 2026
▲Full ResultsZORYVEApprovedClinical Data
Positive results from INTEGUMENT-INFANT Phase 2 open-label study in infants aged 3 months to <24 months
atopic dermatitissource ↗
Drug Pipeline Intelligence
B77
Pipeline Score $15.0B
Pipeline ValueUndervalued
Valuation Signal14
Drugs Scored5.8x
rNPV / MCap Top 97%
Small Cap (rank 28 of 905)
Percentile RankArcutis Biotherapeutics, Inc. holds a solid B-grade pipeline (77/100), with $23.0B risk-adjusted pipeline value, led by Roflumilast 0.3% in Chronic Plaque Psoriasis (Phase 3), across $185B in total addressable markets.
Showing 1 of 1 assets
| Drug | Indication | Phase | NCT ID | PTRS | rNPV | Status | Enrollment | Velocity | Design | Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Roflumilast 0.3% Small molecule | Chronic Plaque Psoriasis | Phase 3 | NCT04211363 | 58% | $5.0B | COMPLETED | 772 | - | - | Nov 16, 2020 | - | Dec 7, 2022 |
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
ZORYVE | atopic dermatitis | Phase 2 | 2026-03-30 | |||
ZORYVE | atopic dermatitis | Phase 2 | 2026-03-30 | |||
ZORYVE | atopic dermatitis | Phase 2 | 2026-03-30 |
Inside Trades
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLDINSIDERS
BOUGHT
SOLDINSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Hedge Funds
Shares Held
HEDGE FUNDS
SOLDHEDGE FUNDS
BOUGHT
SOLDHEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Hedge Funds invested in ARQT
| HedgeFund Name ( 3 ) | % of Portfolio | Current MV - | Shares Owned - | Activity Avg Price $0 |
|---|---|---|---|---|
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K |
ARQT Institutional Ownership Trends
Current Insider %
5.20%
—+0.00%
Current Institutional %
62.40%
—+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
| Expiration | Volume | Open Interest | Implied Volatility Calls | Implied Volatility Puts | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calls | Puts | Put-Call Ratio | Calls | Puts | Put-Call Ratio | IV | OiWaIv | VWaIv | IV | OiWaIv | VWaIv | |
| 2026-07-17 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2026-07-17 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2026-07-17 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last Price | Volume | Open Interest | Last Price | Volume | Open Interest | |
| No data available | ||||||
Open interest
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
ARQTArcutis Biotherapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Arcutis Biotherapeutics, Inc. has announced the grant of 44,000 restricted stock units to six new employees, as part of its 2022 Inducement Plan under Nasdaq Listing Rule 5635(c)(4). The stock units will vest over four years, contingent on continued employment. This action demonstrates Arcutis' focus on enhancing its workforce to support its innovations in the field of immuno-dermatology.
Read more →ARQTArcutis Management to Present at Goldman Sachs 47th Annual Global Healthcare Conference
Arcutis Biotherapeutics, Inc. will present at the Goldman Sachs 47th Annual Global Healthcare Conference from June 8-10, 2026, in Miami. The company's participation includes a fireside chat on June 9, 2026. Arcutis is engaged in developing innovative dermatological treatments, addressing the needs of those with immune-mediated skin conditions. The company highlights its advanced targeted topicals that treat major inflammatory skin diseases.
Read more →ARQTArcutis Announces First Quarter 2026 Financial Results and Provides Business Update
Arcutis Biotherapeutics reported strong Q1 2026 financial results, with net product revenues for ZORYVE reaching $105.4 million. This reflects a substantial year-over-year increase of 65%, although there was a 17% decline from the previous quarter. The company has made strides in its pipeline, including the submission of a supplemental NDA to expand the indication for ZORYVE and the initiation of a Phase 1 clinical trial for ARQ-234. Despite the positive revenue growth, the company faced increased R&D expenses and a sequential decline in sales.
Read more →ARQTArcutis Submits Supplemental New Drug Application to the FDA for ZORYVE® (roflumilast) Cream 0.05% to Expand Indication for Treatment of Atopic Dermatitis to Infants Down to 3 Months
Arcutis Biotherapeutics has submitted a supplemental New Drug Application to the FDA for ZORYVE cream 0.05%, aiming to expand its use to treat mild to moderate atopic dermatitis in infants as young as 3 months. The submission is backed by positive results from the INTEGUMENT-INFANT Phase 2 study, which demonstrated the cream's safety and efficacy. If approved, this treatment could provide a vital non-steroidal option for infants facing limited therapeutic choices.
Read more →ARQTArcutis’ ZORYVE (roflumilast) Cream Receives Strong Recommendation in American Academy of Dermatology First-Ever Pediatric Atopic Dermatitis Guidelines
Arcutis Biotherapeutics announced that ZORYVE (roflumilast) cream has received a strong recommendation in the American Academy of Dermatology's guidelines for pediatric atopic dermatitis. The guidelines support the use of ZORYVE for children aged 2-5 years and those 6 years and older, emphasizing its efficacy, safety, and tolerability. Clinical trials indicate low rates of treatment discontinuation, marking ZORYVE as an effective topical treatment option for managing this chronic condition. The pediatric guideline includes a total of 27 recommendations emphasizing the need for effective topical therapies for atopic dermatitis management.
Read more →ARQTArcutis to Report First Quarter 2026 Financial Results and Host Conference Call on May 6, 2026
Arcutis Biotherapeutics, Inc. will report its first quarter 2026 financial results on May 6, 2026, after market close. The company will also host a conference call at 4:30 PM ET on the same day. This event will provide a business update and is part of Arcutis's commitment to transparency with its stakeholders.
Read more →ARQTPalvella Therapeutics Appoints Accomplished Commercial Leader Kent Taylor as Senior Vice President of Sales
Palvella Therapeutics has appointed Kent Taylor as Senior Vice President of Sales. Taylor, who has over 25 years of experience in pharmaceutical sales, will lead the U.S. sales organization in anticipation of the potential launch of QTORIN™ rapamycin for treating microcystic lymphatic malformations. His previous roles include significant contributions to successful dermatology product launches.
Read more →ARQTArcutis Management to Present at the 25th Annual Needham Virtual Healthcare Conference
Arcutis Biotherapeutics, Inc. will present at the 25th Annual Needham Virtual Healthcare Conference from April 13-16, 2026. The presentation will include a fireside chat on April 14 at 11:00 am ET. The company aims to address the needs of patients with immune-mediated dermatological diseases through innovative therapies.
Read more →ARQTArcutis Presents New Phase 2 Results in Infants with Atopic Dermatitis in Late-Breaking Session Today at the 2026 American Academy of Dermatology Annual Meeting
Arcutis Biotherapeutics presented promising Phase 2 trial results for ZORYVE cream, showing its effectiveness in treating mild to moderate atopic dermatitis in infants aged 3 months to less than 24 months. The study demonstrated significant symptom reduction and rapid itch relief, with a favorable safety profile. These findings support the company's plans for a supplemental New Drug Application to the FDA.
Read more →ARQTArcutis to Present New Clinical Data in a Late-Breaking Podium Presentation and Scientific Posters at the 2026 American Academy of Dermatology Annual Meeting
Arcutis Biotherapeutics announced it will present new clinical data for ZORYVE at the upcoming 2026 American Academy of Dermatology Annual Meeting. The company will showcase results from the INTEGUMENT-INFANT Phase 2 trial, which focuses on infants with atopic dermatitis, and various outcomes from other clinical trials related to dermatological conditions. This presentation highlights the ongoing development and efficacy of ZORYVE, which has received recognition within the dermatology field for its therapeutic impact.
Read more →ARQTArcutis Announces Publication of Positive Long-Term Safety and Efficacy Data with ZORYVE (roflumilast) Cream 0.05% for Treatment of Mild-to-Moderate Atopic Dermatitis in Children Ages 2–5 in Pediatric Dermatology
Arcutis Biotherapeutics has announced positive long-term safety and efficacy results for ZORYVE (roflumilast) cream 0.05% in treating mild-to-moderate atopic dermatitis in children aged 2-5. Published data from a Phase 3 open-label extension study shows that the cream is safe, well-tolerated, and maintains its efficacy over 56 weeks of treatment. Additionally, a significant number of children were able to sustain disease control with minimal adverse effects. This reinforces the importance of ZORYVE as an effective treatment option for pediatric patients suffering from atopic dermatitis.
Read more →ARQTArcutis Announces Promotion of Mas Matsuda to Executive Vice President and Chief Legal Officer to Support Next Phase of Growth
Arcutis Biotherapeutics has promoted Mas Matsuda to Executive Vice President and Chief Legal Officer. Matsuda, who has been with the company since January 2022, will continue to lead legal and compliance strategies as Arcutis aims for further growth and commercialization of its ZORYVE portfolio. His leadership is expected to be pivotal in the company's ongoing success.
Read more →ARQTArcutis Begins Enrolling Phase 1a/1b Study Evaluating ARQ-234, a CD200R Agonist, in Healthy Volunteers and Adults With Atopic Dermatitis
Arcutis Biotherapeutics has initiated a Phase 1a/1b clinical trial for ARQ-234, a CD200 receptor agonist, aimed at evaluating its safety and tolerability in healthy volunteers and adults with moderate to severe atopic dermatitis. The study will include approximately 125 participants and assess various dosing regimens. ARQ-234 is designed to help regulate immune responses, addressing critical needs in atopic dermatitis treatment.
Read more →ARQTArcutis Management to Present at TD Cowen’s 46th Annual Health Care Conference
Arcutis Biotherapeutics, Inc. announced that its management will present at the TD Cowen 46th Annual Health Care Conference from March 2-4, 2026, in Boston. The presentation will include a fireside chat on March 2 at 1:50 p.m. ET. The conference webcast will be available on the company's website.
Read more →ARQTArcutis Announces Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update
Arcutis Biotherapeutics reported a strong financial performance for Q4 and the full year 2025, with a 90% increase in net product revenue driven by ZORYVE's success. The company has a solid cash position and raised its revenue guidance for 2026. However, R&D expenses increased due to clinical development costs, and there was a reduction in other revenue.
Read more →ARQTDocument Arcutis Announces Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update Q4 2025 net product revenue for ZORYVE (roflumilast) was $127.5 million, an 84% increase compared to Q4 2024, an
Arcutis Biotherapeutics reported strong financial results for Q4 and full year 2025, highlighting significant growth in net product revenue for its primary product, ZORYVE. The company noted an 84% year-over-year increase in Q4 revenue, leading to a total of $372.1 million for the year, a 123% increase from 2024. Additionally, Arcutis announced plans to expand its sales force and aims to submit a Supplemental New Drug Application for ZORYVE in young children by Q2 2026. The company has also successfully secured Medicare access for the product starting January 2026.
Read more →ARQTProfessional Golfer Max Homa Joins Arcutis’ Free to Be Me Campaign, Urging Individuals with Seborrheic Dermatitis to Tee Up a Conversation with Their Healthcare Provider About Long-Term Treatments
Arcutis Biotherapeutics announced that professional golfer Max Homa has joined their 'Free to Be Me' campaign to raise awareness about seborrheic dermatitis. Homa shares his personal struggles with the condition and emphasizes the importance of consulting healthcare providers for effective long-term treatments. The campaign aims to encourage individuals to seek proper diagnosis and treatment options, particularly highlighting ZORYVE foam as a viable therapy.
Read more →ARQTArcutis Biotherapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - February 5, 2026
Arcutis Biotherapeutics has granted 94,000 restricted stock units to 12 new employees as part of its 2022 Inducement Plan. This grant, approved by the Compensation Committee, is intended to incentivize new hires and aligns with Nasdaq Listing Rule 5635(c)(4). The units will vest over four years, promoting employee retention.
Read more →ARQTArcutis Announces Positive Topline Results for INTEGUMENT-INFANT Phase 2 Trial of ZORYVE® (roflumilast) Cream 0.05% in Infants with Mild to Moderate Atopic Dermatitis
Arcutis Biotherapeutics announced positive topline results from the INTEGUMENT-INFANT Phase 2 trial of ZORYVE cream 0.05% for treating mild to moderate atopic dermatitis in infants. The study demonstrated that the cream was well tolerated, with a low incidence of mild to moderate adverse events. Notably, 58% of participants achieved significant improvement in their condition by Week 4. This trial reinforces the safety and efficacy of ZORYVE cream for young patients.
Read more →ARQTArcutis Biotherapeutics, Inc. Announces Termination of Promotion Agreement with Kowa
Arcutis Biotherapeutics has mutually terminated its promotion agreement with Kowa Pharmaceuticals for ZORYVE. Following this, Arcutis will assume responsibility for promoting ZORYVE in pediatric and primary care settings. The company anticipates this change will not negatively impact its 2026 net product sales guidance and plans to provide further updates during its upcoming earnings call.
Read more →ARQTArcutis to Report Fourth Quarter and Full Year 2025 Financial Results and Present at Upcoming Investor Conference
Arcutis Biotherapeutics will report its fourth quarter and full year 2025 financial results on February 25, 2026, after market close. The company will also host a conference call and participate in the Guggenheim Emerging Outlook: Biotech Summit on February 11, 2026. This engagement highlights Arcutis' commitment to transparency and investor relations.
Read more →ARQTNationwide Survey Underscores Concerns with Use of Topical Steroids and Need for Long-Term Treatment Strategies Facing the 46 Million Americans with Chronic Inflammatory Skin Conditions
Arcutis Biotherapeutics released findings from a nationwide survey revealing that many adults and parents of children with chronic inflammatory skin conditions, such as psoriasis and eczema, are concerned about the use of topical steroids. The survey indicates a preference for proactive disease management over reactive treatment strategies. It highlights the emotional strain associated with these conditions and the need for safer, effective alternatives.
Read more →ARQTArcutis Highlights 2026 Strategic Priorities and Anticipated Milestones
Arcutis Biotherapeutics has outlined its strategic priorities for 2026, highlighting continued growth of its product ZORYVE with an expected $455–$470 million in net sales. The company is initiating Phase 2 trials for expanding ZORYVE's indications, as well as starting clinical development for a new therapy, ARQ-234, aimed at atopic dermatitis. With a transition to positive cash flow, Arcutis plans to enhance its commercial capabilities and drug pipeline to solidify its leadership in dermatology.
Read more →ARQTMedia Amanda Sheldon, Head of Corporate Communications media arcutis.com Investors Brian Schoelkopf, Head of Investor Relations ir arcutis.com
Arcutis Biotherapeutics has appointed Amit Munshi to its Board of Directors, effective December 4, 2025, and announced the retirement of Bhaskar Chaudhuri. Munshi's extensive background in biotechnology and corporate strategy is expected to aid in the company's growth and product commercialization. Arcutis emphasizes its commitment to addressing unmet needs in dermatology through innovative solutions and has highlighted the successes of its flagship product, ZORYVE.
Read more →ARQTArcutis Strengthens Board of Directors with New Appointment of Amit Munshi and Honors Retirement of Bhaskar Chaudhuri
Arcutis Biotherapeutics has appointed Amit Munshi to its Board of Directors, effective December 4, 2025, while honoring the retirement of long-serving member Bhaskar Chaudhuri. Munshi's appointment is expected to enhance Arcutis's commercialization of its product ZORYVE and support the company's expanding pipeline in medical dermatology. Chaudhuri, who played a crucial role in the development of ZORYVE and the company’s growth, will continue to serve as a consultant. This leadership transition marks a significant phase of growth for Arcutis as it aims to address unmet needs in dermatological care.
Read more →ARQTArcutis Completes Enrollment in INTEGUMENT-INFANT Phase 2 Study Evaluating ZORYVE® (roflumilast) Cream 0.05% in Infants with Atopic Dermatitis
Arcutis Biotherapeutics has completed enrollment in the INTEGUMENT-INFANT Phase 2 study, evaluating ZORYVE cream 0.05% for infants with atopic dermatitis. The study aims to assess the safety and tolerability of the cream in infants aged 3 months to less than 24 months. Topline results are expected in Q1 2026, highlighting the company's commitment to addressing the needs of this vulnerable population.
Read more →ARQTArcutis Announces Publication of Positive Long-Term Safety and Efficacy Data of ZORYVE® (roflumilast) Foam 0.3% in Individuals with Seborrheic Dermatitis in American Journal of Clinical Dermatology
Arcutis Biotherapeutics announced the publication of positive long-term safety and efficacy data for ZORYVE foam in treating seborrheic dermatitis. The Phase 2 study demonstrated that the foam is safe and effective for up to 52 weeks, with significant improvements in symptoms reported. The treatment was well-tolerated, with a high percentage of participants achieving clear skin by the end of the study.
Read more →ARQTMother-Daughter Duo, Tori Spelling and Stella McDermott, Partner With Arcutis Biotherapeutics in the Free to Be Me Campaign, Urging People With Inflammatory Skin Conditions to Speak With Their Healthcare Provider About Long-Term Treatments
Arcutis Biotherapeutics launched the 'Free to Be Me' campaign featuring Tori Spelling and her daughter Stella to raise awareness about inflammatory skin conditions. The campaign highlights the emotional and physical burdens faced by those with conditions like atopic dermatitis and seborrheic dermatitis. It encourages patients to consult healthcare providers for long-term treatment options, showcasing ZORYVE as an effective topical treatment.
Read more →ARQTArcutis Launches ZORYVE (roflumilast) Cream 0.05% for the Treatment of Mild to Moderate Atopic Dermatitis in Children Ages 2 to 5
Arcutis Biotherapeutics has launched ZORYVE (roflumilast) cream 0.05% for treating mild to moderate atopic dermatitis in children aged 2 to 5. This topical treatment is once-daily, steroid-free, and provides long-term disease control without duration restrictions. The launch aims to address the lack of effective treatments for young children suffering from this common skin condition. ZORYVE cream will be available in pharmacies this week, and the company is working to ensure similar coverage through pharmacy benefit managers.
Read more →ARQTArcutis Outlines Strategy for Driving Sustainable Growth and Announces Third Quarter 2025 Financial Results
Arcutis Biotherapeutics has outlined its strategy for sustainable growth and reported strong financial results for Q3 2025, with revenues increasing significantly from the previous year. The company continues to lead in medical dermatology with its ZORYVE product line, which has shown commercial momentum. However, R&D expenses have remained stable, and cash reserves have decreased compared to the end of 2024.
Read more →ARQTDocument Arcutis Outlines Strategy for Driving Sustainable Growth and Announces Third Quarter 2025 Financial Results Q3 2025 net product revenue for ZORYVE (roflumilast) was $99.2 million, a 122% increase compared to Q3
Arcutis Biotherapeutics reported strong financial results for Q3 2025, with net product revenue for ZORYVE reaching $99.2 million, up 122% from the previous year. The company has received FDA approval for a new formulation of ZORYVE for young children and is expanding its clinical pipeline. Arcutis expects to generate full-year net product revenue between $455 million and $470 million in 2026, reflecting its commitment to sustainable growth and innovation in dermatology. Results were announced ahead of an Investor Day focusing on their strategic initiatives.
Read more →ARQTArcutis to Present at Upcoming Investor Conferences
Arcutis Biotherapeutics, Inc. announced its participation in two upcoming investor conferences, including Guggenheim's Healthcare Innovation Conference and TD Cowen's Immunology & Inflammation Summit. The events will feature fireside chats with Arcutis management, showcasing the company's commitment to innovation in dermatology. Webcasts will be available for interested parties.
Read more →ARQTArcutis to Present New Quality of Life and Long-Term Data with ZORYVE® (roflumilast) Cream 0.15% and 0.05% for the Treatment of Atopic Dermatitis at the Fall Clinical Dermatology Conference
Arcutis Biotherapeutics announced new data on ZORYVE cream for atopic dermatitis, demonstrating its effectiveness in improving quality of life by reducing sleep disruptions. The findings will be presented at the Fall Clinical Dermatology Conference. ZORYVE cream has shown long-term disease control and is well-tolerated in patients aged 2 years and older.
Read more →ARQTFDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5
Arcutis Biotherapeutics has received FDA approval for ZORYVE cream 0.05% to treat mild to moderate atopic dermatitis in children aged 2 to 5. This topical treatment offers a steroid-free alternative, showing significant improvements in symptoms within four weeks. The approval marks the sixth for the ZORYVE portfolio, aiming to enhance treatment options for pediatric patients.
Read more →ARQTArcutis Biotherapeutics to Host Virtual Investor Day and Report Third Quarter 2025 Financial Results on October 28, 2025
Arcutis Biotherapeutics, Inc. announced it will report its third quarter 2025 financial results on October 28, 2025, and will host a virtual Investor Day. The event will focus on the company's growth strategy for ZORYVE, advancements in clinical development, and its financial outlook. Management will present and conduct a Q&A session, providing investors with deeper insights into the company’s initiatives and pipeline. A live webcast of the event will be available on the company's website.
Read more →ARQTArcutis To Present Multiple New ZORYVE (roflumilast) Data Analyses at European Academy of Dermatology and Venereology Congress
Arcutis Biotherapeutics announced the presentation of new analyses of ZORYVE (roflumilast) at the 34th Annual European Academy of Dermatology and Venereology Congress. Data indicates that ZORYVE foam 0.3% significantly reduces seborrheic dermatitis symptoms across diverse skin types and improves quality of life in children with atopic dermatitis. Both ZORYVE cream and foam show efficacy for plaque psoriasis, highlighting their potential for treating common skin conditions. Arcutis remains committed to advancing treatment options for inflammatory skin diseases.
Read more →ARQTArcutis Submits Supplemental New Drug Application for ZORYVE (roflumilast) Cream 0.3% to Expand Indication for Treatment of Plaque Psoriasis in Children Ages 2 to 5
Arcutis Biotherapeutics has submitted a supplemental New Drug Application to the FDA for ZORYVE cream (roflumilast) 0.3% to expand its indication for treating plaque psoriasis in children aged 2 to 5. If approved, ZORYVE would be the first topical PDE4 inhibitor available for this young demographic, offering a safe and effective alternative to existing treatments. The application is backed by positive data from usage studies in children and aims to fill a significant gap in treatment options. The cream has been well received for its tolerability and is designed for use even in sensitive skin areas.
Read more →ARQTDocument Arcutis Announces Second Quarter 2025 Financial Results and Provides Business Update Q2 2025 net product revenue for ZORYVE (roflumilast) was $81.5 million, a 164% increase compared to Q2 of 2024, and a 28% incr
Arcutis Biotherapeutics reported strong financial results for Q2 2025, with net product revenue for ZORYVE reaching $81.5 million, a notable 164% increase year-over-year. The quarter saw successful FDA approvals for ZORYVE products, alongside the initiation of new clinical studies targeting pediatric atopic dermatitis. Despite the positive revenue growth, the company reported a net loss of $15.9 million and significant SG&A expenses. Overall, Arcutis aims to expand its dermatology portfolio further in the coming months.
Read more →ARQTArcutis Announces Second Quarter 2025 Financial Results and Provides Business Update
Arcutis Biotherapeutics reported strong financial results for Q2 2025, achieving net product revenues of $81.5 million, a 164% increase from the previous year. The company received FDA approval for a new indication of its ZORYVE foam and initiated a new study for ZORYVE cream in infants. However, they decided to halt further development of ARQ-255 due to unmet efficacy thresholds. Despite a net loss of $15.9 million, the company remains optimistic about its pipeline and the growth of ZORYVE's market demand.
Read more →ARQTArcutis to Report Second Quarter 2025 Financial Results and Host Conference Call on August 6, 2025
Arcutis Biotherapeutics, Inc. is set to report its second quarter 2025 financial results on August 6, 2025, after the U.S. markets close. The company will also host a conference call and provide a business update during the same event. Arcutis specializes in immuno-dermatology, with a portfolio aimed at treating significant inflammatory skin diseases. The event will be accessible via a live webcast, with an archived replay available afterwards.
Read more →ARQTArcutis’ ZORYVE (roflumilast) Cream 0.15% Receives Strong Recommendation in American Academy of Dermatology Updated Guidelines for Adult Atopic Dermatitis
Arcutis Biotherapeutics announced that ZORYVE (roflumilast) cream 0.15% has received a strong recommendation from the American Academy of Dermatology for managing mild to moderate atopic dermatitis in adults. This recommendation confirms ZORYVE's clinical efficacy, safety, and low treatment discontinuation rates. As the first FDA-approved branded topical PDE4 inhibitor for atopic dermatitis, ZORYVE offers patients an important non-steroid treatment option. The guideline update emphasizes the need for evidence-based recommendations that cater to patients and clinicians managing chronic dermatological conditions.
Read more →ARQTArcutis Enrolls First Child in INTEGUMENT-INFANT Evaluating ZORYVE (roflumilast) Cream 0.05% in Infants with Atopic Dermatitis
Arcutis Biotherapeutics has announced the enrollment of the first child in its Phase 2 study, INTEGUMENT-INFANT, evaluating the investigational ZORYVE (roflumilast) cream for infants aged 3 months to under 2 years with atopic dermatitis. This study aims to assess the safety and tolerability of the cream applied once daily for four weeks. Given the high prevalence and impact of atopic dermatitis in children, this trial is seen as a significant step towards addressing the lack of approved treatments for this age group. The company believes that ZORYVE may offer a new therapeutic option that could potentially reduce or replace the use of steroids in pediatric dermatology.
Read more →ARQTArcutis to Present New Long-Term Results of ZORYVE (roflumilast) Cream at the 2025 Revolutionizing Atopic Dermatitis Conference
Arcutis Biotherapeutics announced the presentation of new data from its Phase 3 INTEGUMENT-OLE long-term study at the 2025 Revolutionizing Atopic Dermatitis Conference. The results highlight the durable efficacy of ZORYVE cream in children aged 2 to 5 with atopic dermatitis, showing significant disease control lasting an average of 238 days with proactive use. The cream demonstrated consistent safety and tolerability, reinforcing its potential as a long-term, steroid-free option for managing symptoms. The data also indicate meaningful improvements in itch and affected body surface area over time for patients of all ages.
Read more →ARQTArcutis to Present at the Goldman Sachs 46th Annual Global Healthcare Conference
Arcutis Biotherapeutics, Inc. will participate in the Goldman Sachs 46th Annual Global Healthcare Conference on June 10, 2025. The company, focused on immuno-dermatology, is set to discuss its advancements in treating immune-mediated skin diseases. A replay of the conference will be available on the company’s website for 180 days afterward. This event highlights Arcutis' commitment to addressing significant dermatological conditions with their innovative therapies.
Read more →ARQTArcutis’ ZORYVE (roflumilast) Topical Foam 0.3% Approved by U.S. FDA for the Treatment of Plaque Psoriasis in Adults and Adolescents Ages 12 and Older
Arcutis Biotherapeutics has received FDA approval for ZORYVE (roflumilast) topical foam 0.3% for the treatment of plaque psoriasis in adults and adolescents aged 12 and older. This once-daily foam is noted for its effective clearance of psoriasis and rapid itch relief, particularly in hard-to-treat areas like the scalp. The approval marks the fifth for ZORYVE in less than three years, highlighting the drug's potential to significantly improve the quality of life for those suffering from plaque psoriasis. The product is now widely available, providing both healthcare providers and patients with an important new treatment option.
Read more →ARQTArcutis Announces Publication of Positive Data from ARRECTOR Trial Evaluating ZORYVE (roflumilast) Foam 0.3% in Individuals with Psoriasis in Journal of American Medical Association Dermatology
Arcutis Biotherapeutics announced the publication of positive data from the ARRECTOR trial in JAMA Dermatology, showcasing the efficacy and safety of ZORYVE (roflumilast) foam 0.3% for treating scalp and body psoriasis. The trial indicated that 66.4% of participants achieved significant improvements in scalp psoriasis by week 8, while 45.5% saw improvements in body psoriasis. ZORYVE foam demonstrated rapid symptom relief, particularly for itch, and was well-tolerated among patients. The drug is currently under review by the FDA, with a target action date set for May 22, 2025.
Read more →ARQTArcutis Announces First Quarter 2025 Financial Results and Provides Business Update
Arcutis Biotherapeutics reported strong financial results for the first quarter of 2025, with net product revenue for ZORYVE reaching $63.8 million, a 196% increase year-over-year. Demand for ZORYVE continues to grow, solidifying its position as the most prescribed non-steroidal treatment for inflammatory skin conditions. Despite a slight decrease in revenue compared to the previous quarter and a net loss of $25.1 million, the company is optimistic about future growth due to upcoming product catalysts and expanded market opportunities. Notably, all major national Pharmacy Benefit Managers now cover the ZORYVE portfolio.
Read more →ARQTDocument Arcutis Announces First Quarter 2025 Financial Results and Provides Business Update Q1 2025 net product revenue for ZORYVE (roflumilast) was $63.8 million, a 196% increase compared to Q1 of 2024, and a 2% decrea
Arcutis Biotherapeutics, Inc. reported a 196% increase in net product revenue for ZORYVE in Q1 2025 compared to the same period in 2024. Demand for ZORYVE continues to grow, establishing it as the most prescribed non-steroidal treatment for inflammatory skin conditions. Strong financial performance is highlighted by the expansion of coverage from leading Pharmacy Benefit Managers and ongoing patent litigation relief. However, there was a 2% revenue decrease from Q4 2024, alongside rising administrative expenses.
Read more →ARQTArcutis to Report First Quarter 2025 Financial Results and Host Conference Call on May 6, 2025
Arcutis Biotherapeutics, Inc. has announced that it will report its first quarter 2025 financial results on May 6, 2025, and host a conference call thereafter. The company specializes in immuno-dermatology and aims to innovate in treating skin diseases. Alongside the financial update, Arcutis will provide a business overview and has a portfolio that includes several FDA-approved products. Investors can access the details through a live webcast on their website.
Read more →ARQTArcutis Announces Chief Financial Officer Transition
Arcutis Biotherapeutics announced a transition in its Chief Financial Officer position, with David Topper retiring and Latha Vairavan succeeding him. Over the past year, Topper made significant contributions to the company's financial stability, allowing for future growth. Vairavan, who has extensive experience in finance within the biotech industry, expressed excitement about leading the company's financial operations during an important phase. This leadership change reflects a strategic succession plan aimed at sustaining Arcutis' momentum in the commercial stage of its dermatology innovations.
Read more →ARQTDocument FOR IMMEDIATE RELEASE Arcutis Announces Chief Financial Officer Transition
Arcutis Biotherapeutics, Inc. announced the retirement of CFO David Topper, effective May 15, 2025, with Latha Vairavan set to succeed him. Topper has been with the company since April 2024 and played a crucial role in strengthening Arcutis' financial standing. He will continue to support the transition until the filing of the first quarter 10-Q. Vairavan brings over 20 years of finance experience in the biotech industry to her new role as CFO, indicating a structured succession plan aimed at sustaining growth.
Read more →ARQTArcutis and Padagis Agree to Stay Patent Lawsuit
Arcutis Biotherapeutics has announced that it has agreed to a joint stipulation with Padagis to stay the ongoing patent litigation concerning their drug ZORYVE. This agreement, acknowledged by the U.S. District Court for the District of Delaware, allows both parties to pause legal proceedings while preserving Arcutis's intellectual property rights. The stay also extends the Hatch-Waxman regulatory approval period, benefiting Arcutis should litigation resume. Furthermore, Arcutis is optimistic about its patent portfolio and plans to defend its rights vigorously against any possible infringement by Padagis.
Read more →ARQTArcutis to Present at the 24th Annual Needham Virtual Healthcare Conference
Arcutis Biotherapeutics, Inc. will present at the 24th Annual Needham Virtual Healthcare Conference from April 7-10, 2025. The management team will partake in a fireside chat scheduled for April 8, 2025, at 11:00 am EDT. This participation underscores Arcutis's commitment to addressing significant needs within immuno-dermatology, backed by a robust portfolio that includes three FDA approved products and a variety of pipeline programs. The conference webcasts will be accessible on the company's website.
Read more →ARQTArcutis to Highlight Data from Phase 3 Trials for Scalp and Body Psoriasis and Atopic Dermatitis at the 83rd American Academy of Dermatology Meeting
Arcutis Biotherapeutics presented new data at the 2025 American Academy of Dermatology Meeting regarding their products ZORYVE cream and foam. The data showcased the efficacy, safety, and tolerability of ZORYVE for treating atopic dermatitis and scalp and body psoriasis. In trials, patients reported significant improvements in symptoms and quality of life. The findings support ZORYVE as a viable therapeutic option for those with inadequate responses to standard topical treatments.
Read more →ARQTArcutis to Present Two Posters at the 83rd American Academy of Dermatology Annual Meeting
Arcutis Biotherapeutics, Inc. will present two posters at the 2025 American Academy of Dermatology annual meeting, highlighting new data from Phase 3 trials. One poster will focus on the safety and local tolerability of ZORYVE cream in atopic dermatitis patients with inadequate response to prior treatments. The second will address improvements in patient outcomes with ZORYVE foam in treating scalp and body psoriasis. The event aims to underscore the importance of effective treatments for diverse dermatological conditions.
Read more →ARQTArcutis Announces Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
Arcutis Biotherapeutics reported strong financial results for Q4 2024, with net product revenue for ZORYVE reaching $69.4 million, a significant increase compared to previous quarters and last year. The company also submitted a supplemental New Drug Application for ZORYVE for treating atopic dermatitis in children, reflecting its ongoing commitment to expanding therapeutic options. Management highlighted the successful commercial strategy and positive reception of ZORYVE, further positioning the company for growth in 2025. Despite these gains, the company recorded a net loss, although it was an improvement over the previous year's figures.
Read more →ARQTDocument Arcutis Announces Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update Q4 2024 net product revenue for ZORYVE (roflumilast) was $69.4 million, a 413% increase compared to Q4 of 2023 a
Arcutis Biotherapeutics, Inc. has reported its financial results for the fourth quarter and full year of 2024, highlighting a significant increase in net product revenue for its dermatology treatment ZORYVE. The company achieved a remarkable 413% revenue growth in Q4 2024 compared to the previous year, driven by strong demand and market positioning. Additionally, Arcutis submitted a supplemental New Drug Application for ZORYVE for the treatment of atopic dermatitis in young children, with a focus on future growth and innovation in dermatology. However, the company continues to experience net losses, despite impressive revenue figures.
Read more →ARQTArcutis Announces Publication of Positive Data from INTEGUMENT-PED Trial Evaluating ZORYVE (roflumilast) Cream 0.05% in Children 2 to 5 Years Old with Mild to Moderate Atopic Dermatitis in Pediatric Dermatology
Arcutis Biotherapeutics announced positive results from the INTEGUMENT-PED trial evaluating ZORYVE (roflumilast) cream 0.05% for mild to moderate atopic dermatitis in children aged 2 to 5. The trial demonstrated significant improvements in skin symptoms and itch relief, with results published in Pediatric Dermatology. Following these findings, a Supplemental New Drug Application for ZORYVE cream has been submitted to the FDA.
Read more →ARQTArcutis to Present at the TD Cowen 45th Annual Health Care Conference
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) has announced its participation in the TD Cowen 45th Annual Health Care Conference, scheduled for March 3-5, 2025. The company will be holding a fireside chat on March 4, 2025, at 9:50 am EST, which can be accessed via their website. Arcutis focuses on innovations in immuno-dermatology and has developed multiple FDA-approved products along with a strong pipeline for various dermatological conditions.
Read more →ARQTArcutis to Present at the Guggenheim SMID Cap Biotech Conference
Arcutis Biotherapeutics, Inc. announced its participation in the Guggenheim SMID Cap Biotech Conference set for February 5-6, 2025. The company will host a fireside chat on February 6, 2025, providing an opportunity to discuss their innovations in immuno-dermatology. Arcutis currently has a strong focus on addressing immune-mediated dermatological diseases with a pipeline that includes multiple clinical programs. The company has three FDA-approved products, emphasizing its commitment to tackling significant patient challenges.
Read more →ARQTArcutis Announces Preliminary Unaudited Fourth Quarter Product Revenue and Full-Year 2024 Product Revenues of Approximately $63 Million and $160 Million
Arcutis Biotherapeutics, Inc. announced preliminary unaudited product revenue expected to reach approximately $63 million for Q4 2024 and around $160 million for the full-year 2024, marking significant growth compared to the previous year. The revenue surge is attributed to increased demand for their ZORYVE product line. As of December 31, 2024, the company anticipates having about $229 million in cash and equivalents. Complete financial results will be released on February 25, 2025, along with a conference call for investors.
Read more →ARQTDocument Arcutis Announces Preliminary Unaudited Fourth Quarter Product Revenue and Full-Year 2024 Product Revenues of Approximately $63 Million and $160 Million Preliminary unaudited product revenue for the fourth quart
Arcutis Biotherapeutics announced preliminary unaudited product revenues of approximately $63 million for the fourth quarter of 2024, signifying a substantial growth of 366% compared to Q4 2023. The full-year product revenues for 2024 are estimated at about $160 million, marking a 449% increase from the previous year. The revenue increase is attributed largely to strong demand for their ZORYVE product line. The company also reported liquidity of approximately $329 million, combining cash and available debt.
Read more →ARQTArcutis Submits ZORYVE (roflumilast) Cream 0.05% Supplemental New Drug Application to the FDA for the Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis
Arcutis Biotherapeutics has submitted a supplemental New Drug Application (sNDA) to the FDA for ZORYVE (roflumilast) cream 0.05% aimed at treating mild to moderate atopic dermatitis in children aged 2 to 5. The application is supported by positive outcomes from pivotal trials demonstrating effective skin clearance and itch relief. If approved, this topical treatment could provide a new option for the 1.8 million affected young children in the U.S., while maintaining a strong safety profile even over extended usage. The company emphasizes its commitment to children's dermatological health with this formulation tailored for their sensitive skin.
Read more →ARQTArcutis Announces Promotions on Executive Management Team
Arcutis Biotherapeutics announced several strategic promotions within its executive management team to bolster growth and future success. Key appointments include Patrick Burnett to executive vice president, chief medical officer and L. Todd Edwards to executive vice president, chief commercial officer, both of whom significantly contributed to the company's recent advancements. The promotions aim to drive the adoption and market preference for their product ZORYVE® and reflect the company's commitment to addressing needs in immuno-dermatology. Frank Watanabe, president and CEO, expressed confidence in their ability to lead the organization forward.
Read more →ARQTArcutis’ ZORYVE (roflumilast) Awarded Best Eczema Treatment by Glamour
Arcutis Biotherapeutics, Inc. has announced that its product ZORYVE (roflumilast) cream 0.15% has received the Glamour 2024 Health and Wellness award for Best Eczema Product. This recognition highlights the cream's innovative formulation and effectiveness as a topical treatment for mild to moderate atopic dermatitis. The product is designed to deliver its active ingredient while minimizing irritants that can compromise the skin's barrier. Although ZORYVE is well-regarded, there are important safety considerations, particularly for patients with liver impairments, and common adverse reactions reported include headache and nausea.
Read more →ARQTArcutis Announces Third Quarter 2024 Financial Results and Provides Business Update
Arcutis Biotherapeutics announced strong financial results for Q3 2024, reporting product revenues of $44.8 million for its ZORYVE franchise, significantly up from the same quarter last year. The company highlighted continued demand growth and a successful launch of ZORYVE cream in atopic dermatitis. Key updates include the acceptance of a supplemental New Drug Application for ZORYVE foam by the FDA and an anticipated launch in Canada for seborrheic dermatitis by the end of 2024. Overall, the company demonstrated substantial progress in both revenue growth and product pipeline advancements.
Read more →ARQTDocument Arcutis Announces Third Quarter 2024 Financial Results and Provides Business Update Third quarter net product revenues for ZORYVE (roflumilast) franchise of $44.8M, with $22.0M for ZORYVE cream 0.3%, $20.3M for
Arcutis Biotherapeutics reported strong financial results for Q3 2024, showcasing a remarkable 452% increase in net product revenues for its ZORYVE (roflumilast) franchise, totaling $44.8M. The company has seen sustained growth in prescriptions, with a significant expansion in both cream and foam formulations, driven by positive reception from patients and providers. The FDA accepted a supplemental NDA for ZORYVE foam aimed at treating scalp and body psoriasis, while Health Canada approved ZORYVE foam for seborrheic dermatitis, with plans for a commercial launch expected by the end of 2024. Arcutis is poised for further growth with a strong revenue trajectory and an active pipeline of innovative treatments.
Read more →ARQTArcutis Presents Positive Patient-Reported Outcome Data for ZORYVE (Roflumilast) Cream 0.15% in Atopic Dermatitis at American College of Allergy, Asthma and Immunology 2024 Annual Scientific Meeting
Arcutis Biotherapeutics presented new positive data for ZORYVE cream 0.15% at the ACAAI 2024 Annual Scientific Meeting. The patient-reported outcome data from trials INTEGUMENT-1 and INTEGUMENT-2 showed significant benefits in treating atopic dermatitis, including rapid itch relief and improved quality of life metrics. The findings indicated that over 64% of patients experienced clinically meaningful improvements in skin conditions compared to a lesser percentage with the vehicle. ZORYVE cream is designed for patients aged 6 and older and has demonstrated both efficacy and safety in its clinical trials.
Read more →ARQTArcutis to Report Third Quarter 2024 Financial Results and Participate in an Upcoming Investor Conference
Arcutis Biotherapeutics, Inc. is set to report its third-quarter 2024 financial results on November 6, 2024, accompanied by a conference call and webcast. Additionally, the company will participate in the Guggenheim Securities Healthcare Innovation Conference on November 11, 2024. Arcutis focuses on developing innovative therapies for immune-mediated dermatological diseases and has multiple clinical programs underway. The company emphasizes its strategic approach to addressing patient challenges in dermatology.
Read more →ARQTArcutis Announces Health Canada Approval of ZORYVE (Roflumilast) Foam 0.3% to Treat Seborrheic Dermatitis in Individuals 9 Years of Age and Older
Arcutis Biotherapeutics announced that Health Canada approved ZORYVE (roflumilast) foam 0.3% for treating seborrheic dermatitis in patients aged 9 years and older. This marks the first innovative topical treatment for this condition approved in Canada in over two decades. Over 2 million Canadians are affected by seborrheic dermatitis, and ZORYVE foam promises a safe, effective, and well-tolerated option for these patients. The approval follows positive results from clinical trials, which showed a high rate of treatment success and fast relief for patients.
Read more →ARQTArcutis Announces Publication of ZORYVE (roflumilast) Cream 0.15% Pivotal Results from Phase 3 INTEGUMENT-1 and -2 Trials in Mild to Moderate Atopic Dermatitis in Journal of American Medical Association Dermatology
Arcutis Biotherapeutics announced the publication of pivotal results from its Phase 3 trials for ZORYVE (roflumilast) cream 0.15% in JAMA Dermatology. The studies showed that ZORYVE significantly improved symptoms of mild to moderate atopic dermatitis, with approximately 31% of treated patients achieving the primary efficacy endpoint at Week 4. The cream provided rapid relief from itch, a common symptom of the condition, and maintained a favorable safety profile. ZORYVE is now approved for use in children and adults and is available in pharmacies across the U.S.
Read more →ARQTArcutis Completes Enrollment of Phase 1b Alopecia Areata Study Evaluating ARQ-255
Arcutis Biotherapeutics has announced the completion of patient enrollment in its Phase 1b study assessing ARQ-255, a topical JAK1 inhibitor designed for alopecia areata treatment. The study aims to evaluate the safety, tolerability, and pharmacokinetics of ARQ-255 in both healthy volunteers and individuals with patchy alopecia areata. Results from this trial are anticipated in the first half of 2025, marking a significant step for the company in addressing a condition that currently lacks FDA-approved topical treatments.
Read more →ARQTArcutis Announces Positive Long-Term Results of Roflumilast Cream 0.05% Show Durable and Improved Efficacy Over Time and Favorable Safety Profile in Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis
Arcutis Biotherapeutics announced positive long-term results for roflumilast cream 0.05%, showing improved efficacy and a favorable safety profile in treating mild to moderate atopic dermatitis in children aged 2 to 5. In the INTEGUMENT-OLE study, 71.9% of participants achieved significant clinical improvement at 56 weeks. The company plans to submit a supplemental New Drug Application to the FDA in early 2025 for this formulation. The results indicate potential for this therapy to effectively manage atopic dermatitis in a younger demographic while maintaining safety over an extended period.
Read more →ARQTArcutis to Present at the Morgan Stanley 22nd Annual Global Healthcare Conference
Arcutis Biotherapeutics, Inc. announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference, set for September 5, 2024. The company, focused on immuno-dermatology, boasts a robust product portfolio that includes three FDA-approved therapies. A webcast of the conference will be available on Arcutis' website, with a replay accessible for 180 days post-event. The release also outlines forward-looking statements with accompanying risks related to clinical development and regulatory processes.
Read more →ARQTArcutis Announces Second Quarter 2024 Financial Results and Provides Business Update
Arcutis Biotherapeutics reported significant financial results for Q2 2024, with net product revenues of $30.9 million driven by robust sales of the ZORYVE franchise. The company has seen a strong market demand for ZORYVE cream and foam, showing a 43% increase in sales compared to the previous quarter. They have also entered a co-promotion agreement with Kowa Pharmaceuticals to expand their market outreach. Despite the positive revenue growth, Arcutis reported a net loss of $52.3 million for the quarter, highlighting continued financial challenges.
Read more →ARQTDocument Arcutis Announces Second Quarter 2024 Financial Results and Provides Business Update Second quarter net product revenues for ZORYVE franchise of $30.9M, with $17.3M for ZORYVE (roflumilast) cream 0.3%, and $13.6
Arcutis Biotherapeutics reported second quarter 2024 financial results, with net product revenues from its ZORYVE franchise reaching $30.9 million, marking a significant increase compared to previous quarters. Key developments included a growing demand for ZORYVE cream and foam, an advantageous co-promotion agreement with Kowa Pharmaceuticals, and an sNDA submission aimed at expanding the product's indications. However, the company also reported a net loss of $52.3 million, primarily affected by increased selling and administrative costs associated with its marketing efforts.
Read more →ARQTArcutis to Report Second Quarter 2024 Financial Results and Host Conference Call on August 14, 2024
Arcutis Biotherapeutics, Inc. announced that it will report its second quarter 2024 financial results and provide a business update on August 14, 2024. The company is focusing on immuno-dermatology innovations and will host a conference call at 4:30 p.m. ET on the same day. Arcutis has a portfolio that includes three FDA approved products and is actively developing therapies for various inflammatory dermatological conditions. Additionally, the company cautions about potential risks affecting its business outlook.
Read more →ARQTArcutis Announces ZORYVE U.S. Co-promote Agreement with Kowa Pharmaceuticals America, Inc.
Arcutis Biotherapeutics has announced a co-promotion agreement with Kowa Pharmaceuticals to promote ZORYVE (roflumilast) among primary care practitioners and pediatricians. This agreement aims to expand ZORYVE's reach to the 7.4 million individuals treated for plaque psoriasis, seborrheic dermatitis, and atopic dermatitis outside of dermatology offices. Arcutis will maintain responsibility for sales to dermatologists, and Kowa will utilize its sales force to enhance market access while promoting ZORYVE as a core product. Financial terms of the agreement were not disclosed.
Read more →ARQTArcutis Launches ZORYVE (roflumilast) Cream 0.15% for the Treatment of Atopic Dermatitis
Arcutis Biotherapeutics has announced the commercial launch of ZORYVE (roflumilast) cream 0.15% for treating mild to moderate atopic dermatitis in patients aged 6 and older. The cream is designed as a once-daily, steroid-free option that rapidly alleviates symptoms and can be applied anywhere on the body for long-term use. ZORYVE is available in pharmacies, supported by various patient assistance programs to enhance access. Additionally, the cream has been included in commercial PBM contracts, ensuring coverage for many patients.
Read more →ARQTArcutis Submits Supplemental New Drug Application for ZORYVE (roflumilast) Foam to the FDA for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over
Arcutis Biotherapeutics has submitted a supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) foam for treating scalp and body psoriasis in individuals aged 12 and older. The foam has shown promising efficacy in clinical trials, including significant improvements in scalp and body psoriasis, as well as rapid relief from scalp itch. The submission is supported by data from pivotal Phase 3 trials demonstrating a favorable safety profile. If approved, ZORYVE foam could provide a new, steroid-free treatment option for a large segment of the psoriasis population.
Read more →ARQTArcutis to Host ZORYVE (Roflumilast) Cream 0.15% FDA Approval Call With KOL
Arcutis Biotherapeutics, Inc. announced it will host a virtual Key Opinion Leader event on July 29, 2024, to discuss its recently FDA-approved product, ZORYVE (roflumilast) cream 0.15%. The event will focus on the treatment landscape for mild to moderate atopic dermatitis, which affects millions of patients. ZORYVE is a steroid-free topical PDE4 inhibitor approved for use in adults and children as young as six years old. This cream is part of Arcutis's broader commitment to addressing unmet needs in dermatology.
Read more →ARQTArcutis Provides Update on sNDA for Roflumilast Cream 0.15% for Atopic Dermatitis
Arcutis Biotherapeutics has updated on its supplemental New Drug Application (sNDA) for roflumilast cream 0.15% aimed at treating mild to moderate atopic dermatitis in both adults and children. The FDA has confirmed they are finalizing the action letter without requiring additional information, reflecting positively on the quality of Arcutis's submission. The company expects to receive the action letter soon and is prepared to deliver this innovative treatment upon approval, emphasizing their commitment to addressing urgent dermatological needs.
Read more →ARQTArcutis Announces New Long-Term Data of Roflumilast Cream 0.15% for the Treatment of Mild to Moderate Atopic Dermatitis (AD) in Adults and Children Down to Age Six Presented at Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference
Arcutis Biotherapeutics presented long-term data on roflumilast cream 0.15% for atopic dermatitis at a recent conference. Results from the INTEGUMENT-OLE study indicated sustained efficacy, with over 66% of participants achieving significant improvement in eczema severity. Moreover, those switching to a proactive dosing schedule maintained disease control for an impressive median of 281 days. The cream continues to show a favorable safety profile, supporting its potential as a long-term treatment option for patients.
Read more →ARQTArcutis Announces Multiple Abstracts, Including Oral Presentation, Accepted at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference
Arcutis Biotherapeutics has announced the acceptance of five abstracts for presentation at the upcoming Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference in Chicago. Notable highlights include new long-term data on the safety and efficacy of roflumilast cream 0.15% in patients aged six and older with mild to moderate atopic dermatitis, as well as insights into ARQ-234, a CD200R agonist targeting the condition. The company emphasizes its commitment to advancing treatment options for chronic immune-mediated skin diseases.
Read more →ARQTArcutis to Present at the Goldman Sachs 45th Annual Global Healthcare Conference
Arcutis Biotherapeutics will participate in the Goldman Sachs 45th Annual Global Healthcare Conference scheduled for June 10-13, 2024. The company's management is set to conduct a fireside chat on June 12 at 1:20 pm ET, which will be accessible via webcast. Arcutis focuses on immuno-dermatology, possessing a portfolio that includes two FDA-approved therapies and multiple clinical programs aimed at treating various inflammatory dermatological conditions.
Read more →ARQTArcutis Announces First Quarter 2024 Financial Results and Provides Business Update
Arcutis Biotherapeutics reported impressive financial results for the first quarter of 2024, with product revenues hitting $21.6 million, a 675% increase compared to the same period last year. The company highlighted strong sales growth of its ZORYVE cream and the successful launch of the ZORYVE foam. Arcutis also maintains a solid cash position of $404.5 million following a public offering, with a significant PDUFA action date set for July 7, 2024, for ZORYVE cream as a treatment for atopic dermatitis. Despite the positive financial performance, the company reported a net loss of $35.4 million for the quarter, attributed primarily to increased operational costs associated with product launches.
Read more →ARQTDocument Arcutis Announces First Quarter 2024 Financial Results and Provides Business Update First quarter net product revenues for ZORYVE franchise of $21.6M, with $15M for ZORYVE (roflumilast) cream 0.3%, and $6.5M for
Arcutis Biotherapeutics reported strong first quarter 2024 financial results, with net product revenues reaching $21.6 million, reflecting a significant year-over-year growth driven by ZORYVE products. The company launched ZORYVE foam for seborrheic dermatitis, achieving rapid adoption among prescribers. They also anticipate a PDUFA date on July 7, 2024, for a new roflumilast cream formulation aimed at atopic dermatitis. Despite this positive outlook, the company recorded a net loss of $35.4 million during the quarter, highlighting ongoing financial challenges.
Read more →ARQTArcutis to Report First Quarter 2024 Financial Results and Host Conference Call on May 14, 2024
Arcutis Biotherapeutics, Inc. announced that it will report its first quarter 2024 financial results and provide a business update on May 14, 2024. This announcement follows the company's commitment to innovation in the immuno-dermatology sector, supported by a robust pipeline of clinical programs. A conference call and webcast will take place the same day for further insights.
Read more →ARQTArcutis Appoints David Topper as Chief Financial Officer
Arcutis Biotherapeutics, Inc. has appointed David Topper as the new Chief Financial Officer, effective April 10, 2024. Topper replaces John Smither, who has served as interim CFO since August 2023 and will assist in the transition. The company's CEO, Frank Watanabe, expressed excitement about Topper's extensive experience in finance and capital markets, suggesting that he will contribute significantly to their growth and innovation in dermatology. Arcutis is currently advancing its commercial operations with a focus on innovative therapies for dermatological conditions.
Read more →ARQTnot historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the
Arcutis Biotherapeutics, Inc. has appointed David Topper as its new Chief Financial Officer, replacing John Smither. Topper brings over 25 years of pharmaceutical industry experience, including significant roles in capital markets. Arcutis emphasizes its commitment to innovation in dermatology, backed by a strong development pipeline and the potential for further FDA approvals. The transition in leadership is expected to reinforce the company's financial operations, aiding its mission to advance patient-centric solutions in dermatological conditions.
Read more →ARQTArcutis to Present at the 23rd Annual Needham Virtual Healthcare Conference
Arcutis Biotherapeutics, Inc. will participate in the 23rd Annual Needham Virtual Healthcare Conference from April 8-11, 2024. The company's management is scheduled for a fireside chat on April 11 at 2:15 pm EDT. Interested parties can access the webcast through Arcutis' website, with a replay available for 180 days post-conference. This event highlights Arcutis' ongoing efforts to address patient needs in immuno-dermatology and allows for interaction with the investment community.
Read more →ARQTArcutis Promotes Todd Tucker to Chief Human Resources Officer
Arcutis Biotherapeutics announced the promotion of Todd Tucker to Chief Human Resources Officer, effective immediately. Tucker, who joined the company in 2020, has held various leadership roles in human resources and has been instrumental in improving workforce productivity. The promotion aims to continue fostering a positive corporate culture as Arcutis transitions further into the commercial space, focusing on innovation in medical dermatology.
Read more →ARQTArcutis Presents Late-Breaking Data From INTEGUMENT-PED Phase 3 Trial of Roflumilast Cream 0.05% in Atopic Dermatitis in Children Ages 2 to 5 at the American Academy of Dermatology Annual Meeting
Arcutis Biotherapeutics presented late-breaking results from the INTEGUMENT-PED Phase 3 trial of roflumilast cream 0.05% for treating atopic dermatitis in children aged 2 to 5. The investigational treatment demonstrated significant improvements in efficacy, including a 75% improvement in Eczema Area and Severity Index by Week 4, with rapid onset of relief in itch reported within 24 hours. The trial included 652 children and found that roflumilast cream was well-tolerated, maintaining a low incidence rate of adverse events. This data reinforces the promising safety and efficacy profile of roflumilast cream for young patients.
Read more →ARQTArcutis Announces Closing of Public Offering of Common Stock and Full Exercise by Underwriters of Option to Purchase Additional Shares
Arcutis Biotherapeutics has successfully closed its public offering of 18,157,895 shares of common stock, raising about $172.5 million. This includes the full exercise of an option by underwriters to purchase additional shares, reflecting robust investor interest. The offering was conducted under an effective shelf registration statement filed with the SEC. As a company focused on immuno-dermatology, Arcutis aims to address significant patient needs through innovative therapies.
Read more →ARQTArcutis Announces Acceptance of Late Breaking Abstract in Atopic Dermatitis Among Five New Topical Roflumilast Data Being Presented at the American Academy of Dermatology Annual Meeting
Arcutis Biotherapeutics announced its participation in the 2024 American Academy of Dermatology (AAD) annual meeting, presenting five new studies, including late-breaking data on roflumilast cream 0.05% for children aged 2-5 with atopic dermatitis. The results from the pivotal INTEGUMENT-PED trial will highlight the cream's efficacy in treating mild to moderate atopic dermatitis. Additionally, patient-reported outcomes from Phase 3 trials of ZORYVE, a topical roflumilast treatment, will also be presented. Arcutis is focused on advancing treatment options in immuno-dermatology, with this event showcasing their ongoing research efforts.
Read more →ARQTArcutis to Present at the TD Cowen 44th Annual Health Care Conference
Arcutis Biotherapeutics, Inc. announced its participation in the TD Cowen 44th Annual Health Care Conference scheduled for March 4, 2024. The company is focused on developing innovative solutions in immuno-dermatology and has a growing portfolio of FDA approved products. The conference will feature a fireside chat with the management, which will be accessible via webcast. This participation underscores Arcutis' commitment to addressing urgent needs in dermatological care.
Read more →ARQTArcutis Announces Pricing of $150 Million Public Offering
Arcutis Biotherapeutics, Inc. has announced the pricing of a public offering of 15,789,474 shares at $9.50 each, expected to raise approximately $150 million. This capital will facilitate the commercialization and development of its products for atopic dermatitis and scalp psoriasis. The offering is set to close on March 4, 2024, pending standard conditions. The company has also granted underwriters an option to purchase additional shares, signaling potential investor interest. These funds will supplement Arcutis' existing financial resources to enhance their product portfolio.
Read more →ARQTArcutis and Sato Announce Strategic Collaboration and Licensing Agreement for Topical Roflumilast in Japan
Arcutis Biotherapeutics has entered a strategic collaboration with Sato Pharmaceutical to develop and commercialize topical roflumilast in Japan. Under the agreement, Arcutis will receive a $25 million upfront payment, alongside potential milestone payments totaling $40 million and royalties on future sales. This partnership aims to provide a new, effective treatment option for patients suffering from various inflammatory skin diseases, leveraging roflumilast's established safety and efficacy profile. Sato will manage the development and commercialization efforts within Japan, while Arcutis continues to handle its products in other regions.
Read more →ARQTArcutis Announces Proposed Public Offering
Arcutis Biotherapeutics, Inc. has announced a public offering to raise $150 million through the sale of common stock and pre-funded warrants. This initiative is contingent on market conditions, emphasizing uncertainty surrounding its completion. The company aims to enhance its capabilities in immuno-dermatology, with plans to provide underwriters an option to purchase an additional $22.5 million worth of shares. The securities will be offered in compliance with an effective shelf registration statement filed with the SEC.
Read more →ARQTDocument Arcutis Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update Q4 net product revenues for ZORYVE (roflumilast) cream 0.3% were $13.5 million, a 357% increase compared to the
Arcutis Biotherapeutics announced impressive financial results for Q4 and full year 2023, showing a 357% increase in net product revenues for ZORYVE. The company received FDA approval for ZORYVE topical foam for seborrheic dermatitis, expanding its product offerings. The firm reported a net loss of $66.3 million for the quarter, emphasizing ongoing challenges despite revenue growth. Looking forward, Arcutis plans to invest in further product launches and anticipates significant milestones in 2024.
Read more →ARQTArcutis Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update
Arcutis Biotherapeutics, Inc. reported strong financial results for Q4 and the full year 2023, driven primarily by significant revenue growth from its ZORYVE product line. The company achieved FDA approval for ZORYVE foam, expanding its treatment options, and has strong commercial growth momentum. Despite the positives, Arcutis faced a net loss in Q4 2023 and a notable decrease in cash reserves. Looking ahead, the company expects continued improvement in its financial performance with ongoing product launches and a favorable clinical pipeline.
Read more →ARQTArcutis to Report Fourth Quarter and Full Year 2023 Financial Results
Arcutis Biotherapeutics, Inc. has announced that it will report its fourth quarter and full year financial results on February 27, 2024. The announcement indicates the company's commitment to transparency and ongoing business updates. The investor conference call will take place at 8:30 a.m. ET, with a live webcast available for stakeholders. Arcutis maintains a strong focus on developing innovative therapies for immune-mediated skin conditions, supported by a growing portfolio of FDA-approved products.
Read more →ARQTArcutis to Present at the Guggenheim Healthcare Talks – 6th Annual Biotechnology Conference
Arcutis Biotherapeutics, Inc. announced its participation in the Guggenheim Healthcare Talks, scheduled for February 7, 2024. The company will showcase its innovations in immuno-dermatology and its commitment to addressing the needs of patients with immune-mediated conditions. Additionally, Arcutis highlights its portfolio of two FDA-approved products, along with a diverse pipeline targeting various inflammatory dermatological issues. A replay of the conference webcast will be available for 180 days post-event.
Read more →ARQTtoxc Option Exchange Offer
Arcutis has announced a one-time Option Exchange Offer allowing eligible employees and consultants to voluntarily exchange underwater stock options for restricted stock units (RSUs). This option exchange is set to begin on January 16, 2024, and conclude on February 12, 2024. Participants can exchange all or none of their eligible options, and the exchange ratios depend on the exercise price of the options being exchanged. The program aims to align employee performance with company objectives and address the issue of underwater equity.
Read more →ARQTDocument Arcutis Announces Third Quarter 2023 Financial Results and Provides Business Update Achieved total revenues of $38.1 million in the third quarter of 2023. Net product revenues for ZORYVE (roflumilast) cream 0.3%
Arcutis Biotherapeutics reported strong financial results for Q3 2023, with total revenues of $38.1 million. The company experienced a 70% increase in net product revenues for its ZORYVE cream, which has also received expanded FDA approval for use in children aged 6 and older. The balance sheet was further bolstered by a $100 million follow-on offering. Arcutis is well-positioned for continued growth with additional launches and approvals anticipated in 2024.
Read more →ARQTArcutis Announces Third Quarter 2023 Financial Results and Provides Business Update
Arcutis Biotherapeutics reported its financial results for the third quarter of 2023, achieving total revenues of $38.1 million. A notable highlight was the 70% increase in net product revenues from ZORYVE, which rose to $8.1 million, reflecting increasing demand and improved pricing strategies. The company also received FDA approval for ZORYVE's use in children with plaque psoriasis and made advancements in atopic dermatitis treatment. Additionally, a recent $100 million financing further strengthens their financial position for future growth.
Read more →ARQTArcutis to Report Third Quarter 2023 Financial Results
Arcutis Biotherapeutics, Inc. announced it will hold a conference call on November 3, 2023, to report its third quarter financial results and provide a business update. This early commercial-stage company is dedicated to developing innovative therapies for immune-mediated dermatological conditions, supported by a strong clinical pipeline. The call will include a live webcast, which will later be archived on the company's investor website. Arcutis has cautioned investors about inherent risks associated with forward-looking statements related to its operational progress and regulatory processes.
Read more →ARQTArcutis Announces Pricing of $100 Million Public Offering
Arcutis Biotherapeutics announced a pricing of $100 million for its public offering of common stock and pre-funded warrants. The company plans to sell 32.5 million shares of common stock at $2.50 each, along with 7.5 million pre-funded warrants priced at $2.4999 each. The proceeds from this offering will be utilized for the development of treatments for conditions such as atopic dermatitis and psoriasis. The offering is expected to close on October 24, 2023, pending customary conditions.
Read more →ARQTArcutis Presents Positive Patient-Reported Outcome Data from the Pivotal ARRECTOR Phase 3 Trial in Scalp and Body Psoriasis at European Academy of Dermatology and Venereology (EADV) Congress
Arcutis Biotherapeutics has reported positive results from the Phase 3 ARRECTOR trial of roflumilast foam 0.3% for treating scalp and body psoriasis. Data presented at the EADV Congress indicate significant efficacy, with many patients experiencing rapid improvements in symptoms such as itch and scaling. Results show that 65.3% of participants treated with roflumilast foam had a reduction in itch compared to 30.3% with a vehicle. The treatment demonstrated a favorable safety profile, with a low incidence of adverse effects.
Read more →ARQT8xk Corporate Overview 2 Copyright 2023. Arcutis Biotherapeutics, Inc. - Presentation designed for an investor audience. Legal Disclaimers This presentation and the accompanying oral presentation contain "forward-looking
Arcutis Biotherapeutics presented an overview highlighting its strategy and progress towards becoming a leading immuno-dermatology firm. The company is focused on developing innovative topical therapies and reported sequential revenue growth, with significant net revenues from its ZORYVE product. Recent clinical trials have shown promising efficacy results for atopic dermatitis treatments, and the company expects to receive regulatory approval for a new formulation in the near future. However, Arcutis acknowledges challenges associated with third-party dependencies and potential uncertainties in its forward-looking statements.
Read more →ARQTArcutis Appoints L. Todd Edwards as Chief Commercial Officer
Arcutis Biotherapeutics has appointed L. Todd Edwards as Chief Commercial Officer, effective immediately. Edwards brings over 25 years of relevant experience from leading firms in dermatology, including successful roles at Incyte and UCB. His expertise is anticipated to enhance the company's commercial strategy, particularly in launching ZORYVE cream for plaque psoriasis. Alongside this appointment, Ayisha Jeter has been promoted to Senior Vice President of Marketing and Market Access, highlighting the company's internal talent and commitment to dermatological innovations.
Read more →ARQTArcutis Announces Positive Results from INTEGUMENT-PED Pivotal Phase 3 Trial of Roflumilast Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5
Arcutis Biotherapeutics announced positive results from the INTEGUMENT-PED Phase 3 trial of roflumilast cream 0.05% for treating atopic dermatitis in children aged 2 to 5. The study found that 25.4% of participants achieved significant improvement compared to a 10.7% success rate in the control group, with benefits visible as early as Week 1. The treatment was well-tolerated, with a low incidence of adverse events, allowing for a high completion rate. Following these outcomes, Arcutis plans to pursue FDA approval for this new treatment option.
Read more →ARQTArcutis Submits Roflumilast Cream 0.15% Supplemental New Drug Application to the FDA for the Treatment of Atopic Dermatitis in Adults and Children Ages 6 Years and Older
Arcutis Biotherapeutics has submitted a supplemental New Drug Application (sNDA) for its roflumilast cream 0.15%, targeting treatments for atopic dermatitis in patients aged 6 and older. The cream displayed statistically significant results in Phase 3 trials, improving symptoms, including itch relief, as quickly as 24 hours after application. The product is noted for its favorable safety and tolerability profile, aiming to provide an effective treatment option without the use of steroids. The submission builds on positive data from multiple trials and underscores a commitment to advancing therapeutic options for atopic dermatitis.
Read more →ARQTArcutis Announces Positive Long-Term Results of Roflumilast Cream 0.15% Showing Durable and Improved Efficacy Over Time and Favorable Safety Profile in Treatment of Mild to Moderate Atopic Dermatitis (AD)
Arcutis Biotherapeutics announced positive interim results from the long-term INTEGUMENT-OLE study of roflumilast cream 0.15% for treating atopic dermatitis in patients aged 6 and older. The study found that a substantial percentage of participants maintained and improved their efficacy over the treatment period, achieving vIGA-AD success. Notably, the cream demonstrated a favorable safety profile, similar to short-term data, with no new adverse events reported. These findings support Arcutis' strategy to apply for a supplemental New Drug Application for the cream.
Read more →ARQTArcutis to Present at Upcoming Investor Conference
Arcutis Biotherapeutics will participate in the Morgan Stanley 21st Annual Global Healthcare Conference on September 12, 2023. The company focuses on innovative solutions for immune-mediated dermatological conditions. Its participation in this conference highlights its commitment to investor engagement and addresses urgent needs in the skin health sector. Arcutis is developing several therapies through its robust dermatology platform, but potential risks accompany their forward-looking objectives.
Read more →ARQTArcutis Biotherapeutics Publishes Annual Environmental, Social, and Governance (ESG) Report
Arcutis Biotherapeutics published its annual Environmental, Social, and Governance (ESG) report, detailing advancements made in improving patient care, social capital management, and sustainability throughout 2022. The report aligns with recognized standards like those from the IFRS and SASB, reflecting the company's commitment to ethical practices. CEO Frank Watanabe emphasized the importance of fostering a strong company culture to attract talent and innovate in dermatology. The report can be accessed via the investor relations section of the company's website.
Read more →ARQTArcutis Launches First Television Ad for ZORYVE (Roflumilast) Cream 0.3%
Arcutis Biotherapeutics has launched its first direct-to-consumer television advertisement for ZORYVE (roflumilast) cream, aimed at simplifying psoriasis treatments. The campaign, titled 'The Cream That Can', emphasizes the steroid-free nature of ZORYVE and its accessibility, as it is included with major pharmacy benefit managers. Clinical trials indicate that around 40% of users experienced significant improvement within eight weeks. However, the cream is contraindicated for certain patients and may cause side effects such as diarrhea and headache.
Read more →ARQTArcutis Appoints Interim Chief Financial Officer (CFO)
Arcutis Biotherapeutics has appointed John W. Smither as interim Chief Financial Officer, replacing Scott Burrows who is leaving for another opportunity. Smither, who previously served as CFO from 2019 to 2021, brings significant industry experience. The company is focused on furthering its innovations in dermatology, particularly with its product ZORYVE, which is the first topical phosphodiesterase-4 inhibitor approved for plaque psoriasis. Efforts are ongoing for the anticipated approval of roflumilast foam for seborrheic dermatitis later this year.
Read more →ARQTArcutis and Huadong Announce Strategic Collaboration and Licensing Agreement for Topical Roflumilast in Greater China and Southeast Asia
Arcutis Biotherapeutics has entered a strategic collaboration and licensing agreement with Huadong Medicine for the development and commercialization of topical roflumilast in Greater China and Southeast Asia. Arcutis will receive a $30 million upfront payment and potential milestone payments up to $64.25 million, alongside tiered royalties. The partnership aims to provide innovative treatment options for immune-mediated skin diseases in the targeted regions, with Huadong taking on development and marketing responsibilities. This agreement positions Arcutis to leverage Huadong's regional expertise in dermatology.
Read more →ARQTArcutis Announces Second Quarter 2023 Financial Results and Provides Business Update
Arcutis Biotherapeutics reported a 72% increase in net product revenues for its ZORYVE cream, reaching $4.8 million in Q2 2023. The company has expanded its commercial payer coverage to over 130 million lives and received positive initial responses after launching ZORYVE in Canada. Despite these gains, Arcutis reported a net loss of $71 million, an increase compared to the previous year, and a notable decline in cash reserves. The company continues to invest in its strategic growth and upcoming product launches in dermatology.
Read more →ARQTDocument Arcutis Announces Second Quarter 2023 Financial Results and Provides Business Update Achieved total revenues of $5.2 million in the second quarter of 2023. Net product revenues for ZORYVE (roflumilast) cream 0.3
Arcutis Biotherapeutics reported its financial results for Q2 2023, achieving total revenues of $5.2 million, primarily driven by ZORYVE sales of $4.8 million, a significant 72% increase from the previous quarter. The company has secured expansive commercial payer coverage for ZORYVE, now accessible to over 130 million lives in the U.S. However, they posted a net loss of $71 million, amidst increased R&D and selling expenses due to the ongoing launch and marketing efforts for their products. Looking ahead, Arcutis is preparing for additional product launches in 2024 and anticipates potential FDA approvals for new indications soon.
Read more →ARQTArcutis to Report Second Quarter Financial Results
Arcutis Biotherapeutics, Inc. has announced plans to host a conference call and webcast on August 8, 2023, to report its second quarter financial results. The event will provide insights into the company's performance and ongoing developments in its dermatology pipeline. Arcutis emphasizes its commitment to innovation in treating immune-mediated dermatological diseases. However, the company also cautions about inherent risks associated with clinical development and regulatory processes.
Read more →ARQTArcutis Announces ZORYVE (Roflumilast) Cream 0.3% Has Been Included in a Preferred Position on National Formularies for CVS Caremark
Arcutis Biotherapeutics has announced that its product, ZORYVE (roflumilast) cream 0.3%, has gained a preferred position on CVS Caremark's national formularies effective July 5, thereby expanding access to 131 million covered individuals in the U.S. ZORYVE, a steroid-free treatment for plaque psoriasis, allows for easier access for patients, with most not requiring prior authorization. The cream targets both sensitive and hard-to-treat areas of the body, providing a new option for individuals suffering from this condition. Arcutis aims to maintain affordable access through patient support programs.
Read more →ARQTArcutis Announces Leadership Transition
Arcutis Biotherapeutics has announced that Ken Lock will step down as Chief Commercial Officer, effective June 2, 2023. In his absence, Ayisha Jeter will serve as interim CCO, bringing over 20 years of pharmaceutical industry experience. Under Lock's leadership, the company successfully launched ZORYVE, its first product for plaque psoriasis, and he was instrumental in building the commercial organization. Arcutis is now in the process of finding a permanent replacement for Lock.
Read more →ARQTArcutis Announces First Quarter 2023 Financial Results and Provides Business Update
Arcutis Biotherapeutics reported its first-quarter 2023 financial results, highlighting a revenue of $2.8 million from ZORYVE, which saw nearly double unit demand growth. The company expanded payer coverage for ZORYVE in plaque psoriasis and received Health Canada approval for the product. Arcutis is also progressing in its clinical trials for atopic dermatitis and has a strong cash position with approximately $333 million. However, the company reported a net loss of $80.1 million and increasing SG&A expenses related to its commercialization efforts.
Read more →ARQTDocument Arcutis Announces First Quarter 2023 Financial Results and Provides Business Update Achieved net revenues of $2.8 million for ZORYVE (roflumilast) cream 0.3% in the first quarter of 2023, with unit demand growth
Arcutis Biotherapeutics reported financial results for Q1 2023, achieving net revenues of $2.8 million for ZORYVE, indicating strong unit demand growth. The company expanded commercial coverage for ZORYVE to over 110 million lives in the U.S. and received Health Canada approval for the drug. Additionally, Arcutis' financial position remains robust, with $333 million in cash and equivalents, although it reported a net loss of $80.1 million for the quarter, an increase from the prior year. The company is prioritizing its commercialization efforts to enhance shareholder value.
Read more →ARQTArcutis Completes Enrollment in INTEGUMENT-PED Pivotal Phase 3 Trial of Roflumilast Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5
Arcutis Biotherapeutics has completed the enrollment of 652 children aged 2 to 5 in its INTEGUMENT-PED pivotal Phase 3 trial assessing roflumilast cream 0.05% for atopic dermatitis (AD). The trial is particularly significant as it aims to evaluate a safe and effective treatment option for young children who are traditionally limited in therapy choices. Positive topline data is anticipated in the third quarter of 2023, which may pave the way for a supplemental new drug application submission following prior encouraging results seen in older patients. The cream is designed to be non-greasy and devoid of common irritants, highlighting its suitability for sensitive pediatric skin.
Read more →ARQTArcutis Announces Canadian Approval of ZORYVE™ (roflumilast) Cream 0.3% for Treatment of Plaque Psoriasis in Individuals 12 Years and Older
Arcutis Biotherapeutics announced the Canadian approval of its topical therapy ZORYVE (roflumilast) cream 0.3% for treating plaque psoriasis in individuals aged 12 and older. This marks ZORYVE's first regulatory approval outside the U.S., representing a significant commercial achievement for Arcutis. The cream is distinguished as the first novel steroid-free topical treatment to be approved for plaque psoriasis in over 25 years, addressing a pressing need for effective therapies in this area. Arcutis plans to leverage this approval to enhance its presence in both Canadian and U.S. markets.
Read more →ARQTArcutis to Report First Quarter Financial Results
Arcutis Biotherapeutics, Inc. announced plans to host a conference call and webcast to report its first-quarter financial results on May 9, 2023. The press release and earnings call will provide insights into the company's financial performance and developmental progress in immuno-dermatology. Arcutis is committed to addressing challenges in dermatological conditions through its innovative pipeline, though it acknowledges risks associated with clinical development and regulatory processes. The call aims to update stakeholders on the company's evolving portfolio and strategic efforts.
Read more →ARQTArcutis Announces FDA Acceptance of New Drug Application for Roflumilast Foam 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older
Arcutis Biotherapeutics announced that the FDA accepted its new drug application for roflumilast foam 0.3%, intended for treating seborrheic dermatitis in individuals aged 9 and older. The application has a target action date of December 16, 2023, and is supported by positive data from Phase 2 and Phase 3 trials showing significant improvement in efficacy and safety. If approved, this foam formulation would represent a new mechanism of action for seborrheic dermatitis treatments, addressing a significant unmet need in the dermatology market.
Read more →ARQTArcutis Announces New Coverage for ZORYVE (Roflumilast) Cream 0.3% with National and Regional Health Plan Formularies, Bringing Total Commercial Covered Lives to Over 110 Million
Arcutis Biotherapeutics announced expanded coverage for its plaque psoriasis treatment, ZORYVE (roflumilast) cream 0.3%, now included in eight additional health plans. This pushes the total commercial coverage to over 110 million lives. The company emphasizes ZORYVE's steroid-free formulation as a significant advancement in treatment options for psoriasis. They are also committed to enhancing access through patient support programs, despite some contraindications and potential side effects associated with the product.
Read more →ARQTArcutis Presents Late-Breaking Data from the INTEGUMENT Phase 3 Trials in Atopic Dermatitis at American Academy of Dermatology Annual Meeting
Arcutis Biotherapeutics presented promising late-breaking data from its INTEGUMENT Phase 3 trials at the American Academy of Dermatology meeting. The studies demonstrated that roflumilast cream 0.15% significantly reduced itch and improved atopic dermatitis symptoms in both adults and children within a short timeframe. The treatment achieved high efficacy rates for major endpoints like EASI-75 and IGA Success, showcasing its potential as a safe and effective option. Arcutis plans to file a supplemental new drug application with the FDA in the latter half of the year.
Read more →ARQTArcutis to Present New Topical Roflumilast Data Including Late Breaking Atopic Dermatitis Pivotal Trial Data During the American Academy of Dermatology (AAD) Annual Meeting
Arcutis Biotherapeutics announced the presentation of new clinical data for roflumilast cream at the upcoming 2023 American Academy of Dermatology annual meeting. This includes late-breaking findings from the Phase 3 INTEGUMENT trials for treating atopic dermatitis in patients aged 6 and older. Additional insights on seborrheic dermatitis treatment patterns and efficacy data for both the cream and foam formulations will also be shared. The presentations aim to demonstrate the potential of roflumilast as a leading treatment option in immuno-dermatology.
Read more →ARQTArcutis Announces Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
Arcutis Biotherapeutics, Inc. reported its financial results for Q4 and the full year of 2022, revealing significant revenue from its ZORYVE product, with $3.0 million in net revenues for the first full quarter post-launch. The company also announced positive topline results from two pivotal Phase 3 trials for atopic dermatitis and secured expanded payer coverage for ZORYVE. Despite the positive developments, Arcutis faced a net loss of $72 million in Q4 due to rising expenses in R&D and SG&A, reflecting the costs associated with its ongoing pipeline and product launch efforts.
Read more →ARQTDocument Arcutis Announces Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update Achieved net revenues of $3.0 million for ZORYVE (roflumilast) cream 0.3% in the first full quarter since the Au
Arcutis Biotherapeutics, Inc. reported its financial results for Q4 and the full year of 2022, highlighting net revenues of $3 million for its newly launched product ZORYVE. The company secured expanded coverage for ZORYVE in plaque psoriasis and announced positive results from two pivotal Phase 3 trials for atopic dermatitis. Despite these successes, Arcutis faced a Q4 net loss of $72 million, showcasing financial pressures. The company also maintains a robust cash reserve of $410 million, positioning itself for future growth.
Read more →ARQTArcutis Submits Topical Roflumilast Foam 0.3% New Drug Application to the FDA for the Treatment of Seborrheic Dermatitis in Adults and Adolescents
Arcutis Biotherapeutics has submitted a New Drug Application (NDA) to the FDA for its topical formulation, roflumilast foam 0.3%, aimed at treating seborrheic dermatitis in adults and adolescents. This represents a potential breakthrough as it could be the first new topical treatment with a unique mechanism in over 20 years. Recent Phase 3 trial results indicated significant efficacy, with 80% of the participants achieving significant symptom improvement by Week 8. The treatment demonstrates a favorable safety profile, laying the groundwork for a new standard of care for this commonly challenging skin condition.
Read more →ARQTArcutis to Report Fourth Quarter 2022 Financial Results and Participate in Upcoming Investor Conference
Arcutis Biotherapeutics, Inc. will host a conference call and webcast on February 28, 2023, to report its fourth quarter and full year financial results. The company will also participate in the Cowen 43rd Annual Healthcare Conference in March, featuring a fireside chat and a dermatology panel discussion. Arcutis is focused on innovations in immuno-dermatology and has a strong clinical program addressing multiple inflammatory dermatological conditions. The event and details are available on their investor website.
Read more →ARQTArcutis Presents New Phase 2 Long-Term Data Showing Sustained Efficacy and Clearance for a Median of 10 Months with Roflumilast Cream in Adults with Chronic Plaque Psoriasis
Arcutis Biotherapeutics has presented new data from a Phase 2 study of roflumilast cream, showing sustained efficacy for adults with chronic plaque psoriasis. In the trial, 57.1% of treated participants achieved clear or almost clear skin for a median duration of 10 months. The efficacy was consistent over time, and the treatment was well-tolerated with few adverse events reported. These findings support roflumilast cream as a preferred treatment option for chronic plaque psoriasis, including in difficult-to-treat areas of the body.
Read more →ARQTArcutis Submits Supplemental New Drug Application for ZORYVE (roflumilast) Cream 0.3% for Expanded Indication for the Treatment of Plaque Psoriasis in Children Down to 2 Years of Age
Regulatory submission for the expanded indication is supported by data from two recently completed 4-week Maximal Usage Systemic Exposure (MUSE) studies in children ages 2 to 11 years with plaque psoriasis If approved, ZORYVE would be the first steroid-free topical phosphodieste
Read more →ARQT8xk Corporate Overview 2 Copyright 2022. Arcutis Biotherapeutics, Inc. - Presentation designed for an investor audience. Legal Disclaimers This presentation and the accompanying oral presentation contain "forward-looking
2 Copyright 2022. Arcutis Biotherapeutics, Inc. - Presentation designed for an investor audience. Legal Disclaimers This presentation and the accompanying oral presentation contain "forward-looking" statements that are based on our management's beliefs and assumptions and on info
Read more →ARQTArcutis Announces Positive Topline Results from Second Atopic Dermatitis Pivotal Phase 3 Trial of Roflumilast Cream in Adults and Children Aged 6 and Older
Study met the primary endpoint and key secondary endpoints, consistent with positive topline results from the INTEGUMENT-1 trial released in November For the primary endpoint, 28.9% of individuals treated with roflumilast cream 0.15% achieved Investigator Global Assessment (IGA)
Read more →ARQTArcutis Enrolls First Patient in Phase 1b Alopecia Areata Study Evaluating ARQ-255
ARQ-255 is a topical janus kinase (JAK) inhibitor therapy specifically designed as a potential treatment for alopecia areata Proprietary Deep Dermal Drug Delivery (4D) formulation designed to deliver drug deep into the skin to the base of the hair follicle where key alopecia are
Read more →ARQTArcutis Biotherapeutics Publishes First Environmental, Social, and Governance (ESG) Report
Report highlights efforts to advance diversity and inclusion, access to medicine, sustainable business practices, and governance WESTLAKE VILLAGE, Calif., Nov. 21, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early-stage commercial company focused on
Read more →ARQTArcutis’ ZORYVE (Roflumilast) Cream 0.3% Added to Express Scripts, Inc. National Formularies in the United States
ZORYVE is now on formulary for one of the top pharmacy benefit managers serving commercially insured patients, effective November 18, 2022 ZORYVE is a once-daily non-steroidal cream and the first and only topical PDE4 inhibitor approved for use in plaque psoriasis, including all
Read more →ARQTArcutis Announces Positive Topline Results from INTEGUMENT-1 Pivotal Phase 3 Trial of Roflumilast Cream in Atopic Dermatitis in Adults and Children Aged Six Years and Older
Study met the primary endpoint and all secondary endpoints For the primary endpoint, 32.0% of individuals treated with roflumilast cream 0.15% achieved Investigator Global Assessment (IGA) Success compared to 15.2% of individuals treated with vehicle (P<0.0001) 43.2% of individ
Read more →ARQTDocument Arcutis Announces Third Quarter 2022 Financial Results and Provides Business Update Launched ZORYVE (roflumilast) cream 0.3% for the treatment of plaque psoriasis in adolescents and adults in mid-August, achievi
Arcutis Announces Third Quarter 2022 Financial Results and Provides Business Update Launched ZORYVE (roflumilast) cream 0.3% for the treatment of plaque psoriasis in adolescents and adults in mid-August, achieving net revenues of $0.7 million for the third quarter ZORYVE now co
Read more →ARQTArcutis Announces Third Quarter 2022 Financial Results and Provides Business Update
Launched ZORYVE® (roflumilast) cream 0.3% for the treatment of plaque psoriasis in adolescents and adults in mid-August, achieving net revenues of $0.7 million for the third quarter ZORYVE now covered by one of the top pharmacy benefit managers and a large national health plan
Read more →ARQTArcutis to Report Third Quarter Financial Results
WESTLAKE VILLAGE, Calif., Oct. 25, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early-stage commercial company focused on developing meaningful innovations in immuno-dermatology, today announced that it will host a conference call and webcast at 5:00
Read more →ARQTArcutis Announces Positive Topline Results from ARRECTOR Pivotal Phase 3 Trial of Roflumilast Foam 0.3% in Scalp and Body Psoriasis
Study met both co-primary endpoints and all secondary endpoints At week eight, 67.3% of individuals treated with roflumilast foam achieved Scalp-Investigator Global Assessment (S-IGA) Success compared to 28.1% of individuals treated with vehicle At week eight, 46.5% of individu
Read more →ARQTArcutis Announces Acquisition of Ducentis BioTherapeutics Ltd. Leverages Arcutis' deep dermatology expertise and broad biologics experience to accelerate Ducentis' lead compound, DS-234, in atopic dermatitis Lead indicat
Arcutis Announces Acquisition of Ducentis BioTherapeutics Ltd. Leverages Arcutis' deep dermatology expertise and broad biologics experience to accelerate Ducentis' lead compound, DS-234, in atopic dermatitis Lead indication, atopic dermatitis, is a rapidly growing, significantl
Read more →ARQTDocument Exhibit 1.1 Arcutis Announces Appointment of Neha Krishnamohan to Board of Directors
Arcutis Announces Appointment of Neha Krishnamohan to Board of Directors WESTLAKE VILLAGE, Calif., September 2, 2022 -- Arcutis Biotherapeutics, Inc. (Nasdaq ARQT), an early-stage commercial company focused on developing meaningful innovations in immuno-dermatology, today announ
Read more →ARQTArcutis Announces Appointment of Neha Krishnamohan to Board of Directors
WESTLAKE VILLAGE, Calif., Sept. 02, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early-stage commercial company focused on developing meaningful innovations in immuno-dermatology, today announced that Neha Krishnamohan has been appointed to the Arcuti
Read more →ARQTArcutis Announces Arcutis Cares™ Patient Assistance Program (PAP) For Financially Qualified Uninsured and Underinsured Patients
Arcutis Cares provides ZORYVE™ (roflumilast) cream 0.3% at no cost for financially eligible individuals who are uninsured or have Medicaid or Medicare Part D prescription coverage and cannot afford their medication First ever PAP for a topical psoriasis product WESTLAKE VILLAGE
Read more →ARQTArcutis Launches ZORYVE™ (Roflumilast) Cream 0.3% in the United States for Treatment of Plaque Psoriasis in Individuals Age 12 and Older
Next-generation topical PDE4 inhibitor for adults and adolescents with plaque psoriasis now available in pharmacies nationwide Effective, safe, and very well-tolerated steroid-free cream that rapidly clear plaques and reduces itch Arcutis committed to ensuring affordable access
Read more →ARQTDocument Arcutis Announces Second Quarter 2022 Financial Results and Provides Business Update Received U.S. Food and Drug Administration (FDA) approval for ZORYVE TM (roflumilast) cream 0.3% for the treatment of plaque p
Arcutis Announces Second Quarter 2022 Financial Results and Provides Business Update Received U.S. Food and Drug Administration (FDA) approval for ZORYVETM (roflumilast) cream 0.3% for the treatment of plaque psoriasis, including intertriginous psoriasis, in individuals 12 years
Read more →ARQTArcutis Announces Second Quarter 2022 Financial Results and Provides Business Update
Received U.S. Food and Drug Administration (FDA) approval for ZORYVE™ (roflumilast) cream 0.3% for the treatment of plaque psoriasis, including intertriginous psoriasis, in individuals 12 years of age and older Announced positive topline results from pivotal Phase 3 trial of rof
Read more →ARQTArcutis Completes Enrollment in INTEGUMENT-1 Pivotal Phase 3 Trial of Roflumilast Cream in Atopic Dermatitis
A total of 654 adults and children, age six and older, have been enrolled in the INTEGUMENT-1 trial Enrollment continues in INTEGUMENT-2 with topline data from both trials expected by end of 2022 Atopic dermatitis affects approximately 26 million adults and children in the U.S.
Read more →ARQTArcutis Biotherapeutics Announces Pricing of Public Offering of Common Stock
WESTLAKE VILLAGE, Calif., Aug. 02, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (“Arcutis”) (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the pricing of its underwr
Read more →ARQTCorporate Overview 2 Copyright 2022. Arcutis Biotherapeutics, Inc. - Presentation designed for an investor audience. Legal Disclaimers This presentation and the accompanying oral presentation contain "forward-looking" st
2 Copyright 2022. Arcutis Biotherapeutics, Inc. - Presentation designed for an investor audience. Legal Disclaimers This presentation and the accompanying oral presentation contain "forward-looking" statements that are based on our management's beliefs and assumptions and on info
Read more →ARQTArcutis Biotherapeutics Announces Proposed Public Offering of Common Stock
WESTLAKE VILLAGE, Calif., Aug. 02, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (“Arcutis”) (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the commencement of an un
Read more →ARQTArcutis to Host Investor Conference Call Today to Discuss the FDA Approval of ZORYVE™ (roflumilast) Cream 0.3% for Plaque Psoriasis
WESTLAKE VILLAGE, Calif., Aug. 01, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early-stage commercial biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, will host a conference call for investors today at 8:3
Read more →ARQTArcutis Biotherapeutics Announces Health Canada Accepts for Review the New Drug Submission for Roflumilast Cream for Adults and Adolescents with Plaque Psoriasis
Submission supported by positive clinical data from the pivotal Phase 3 DERMIS-1 and DERMIS-2 clinical studies, as well as results from long-term safety studies If approved, roflumilast cream would be the first and only topical PDE4 inhibitor for psoriasis in Canada Target acti
Read more →ARQT8xk692022 Arcutis Announces Positive Topline Results from STRATUM Pivotal Phase 3 Trial of Roflumilast Foam 0.3% in Seborrheic Dermatitis
Arcutis Announces Positive Topline Results from STRATUM Pivotal Phase 3 Trial of Roflumilast Foam 0.3% in Seborrheic Dermatitis June 6, 2022 Study met its primary endpoint with 80.1% of individuals treated with roflumilast foam achieving Investigator Global Assessment (IGA) Succe
Read more →ARQTArcutis Announces Positive Topline Results from STRATUM Pivotal Phase 3 Trial of Roflumilast Foam 0.3% in Seborrheic Dermatitis
Study met its primary endpoint with 80.1% of individuals treated with roflumilast foam achieving Investigator Global Assessment (IGA) Success compared to 59.2% of patients treated with vehicle (P<0.0001) More than 50% of patients treated with roflumilast foam achieved an IGA sco
Read more →ARQTDocument Arcutis Announces First Quarter 2022 Financial Results and Provides Business Update Increasing commercial preparations in advance of our Prescription Drug User Fee Act (PDUFA) action date of
Arcutis Announces First Quarter 2022 Financial Results and Provides Business Update Increasing commercial preparations in advance of our Prescription Drug User Fee Act (PDUFA) action date of July 29, 2022 for roflumilast cream for the treatment of plaque psoriasis in adults and
Read more →ARQTArcutis Announces First Quarter 2022 Financial Results and Provides Business Update
Increasing commercial preparations in advance of our Prescription Drug User Fee Act (PDUFA) action date of July 29, 2022 for roflumilast cream for the treatment of plaque psoriasis in adults and adolescents Completed enrollment of the sole pivotal Phase 3 trials of roflumilast f
Read more →ARQTArcutis Completes Enrollment in ARRECTOR Pivotal Phase 3 Trial of Topical Roflumilast Foam in Scalp and Body Psoriasis
Topline data anticipated in late Q3/early Q4 A total of 432 subjects are enrolled in the ARRECTOR study Arcutis progressing topical roflumilast in four dermatological indications Over 3 million patients in the U.S. have plaque psoriasis in the scalp WESTLAKE VILLAGE, Calif.,
Read more →ARQTArcutis Highlights Growth Opportunities at Investor Day in Advance of 2022 Catalysts
Differentiated profile of topical roflumilast aligned with unmet needs in multiple inflammatory dermatoses Well-prepared for the Company’s potential first launch ahead of PDUFA target action date of July 29 Clinical program for topical roflumilast continues to advance with anno
Read more →ARQTArcutis’ Roflumilast Foam Demonstrates Clinically Meaningful Results and Patient Quality of Life Improvements in Phase 2 Seborrheic Dermatitis Study
Previously reported data demonstrated that roflumilast foam provided statistically significant improvement in disease severity and a favorable safety and tolerability profile Improvement on Investigator Global Assessment (IGA) Success and itch as early as week 2, the first timep
Read more →ARQTArcutis Presents New Data on Once-Daily Roflumilast Cream for Plaque Psoriasis from DERMIS Phase 3 Trials at American Academy of Dermatology Annual Meeting
Pooled analysis of DERMIS-1 and DERMIS-2 demonstrated significantly more roflumilast-treated patients achieved Investigator Global Assessment (IGA) success (40%) at week 8 compared to vehicle (7%), consistent with results from the individual studies New post hoc analyses showed
Read more →ARQTArcutis to Host Investor Day on March 28
WESTLAKE VILLAGE, Calif., March 21, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, will host an Investor Day in Boston, MA on Monday, March 28, 2022
Read more →ARQTDocument Arcutis Announces Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update Received U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (NDA) for roflumilast cr
Arcutis Announces Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update Received U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (NDA) for roflumilast cream for the treatment of plaque psoriasis in adults and adolescents
Read more →ARQTArcutis Announces Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update
Received U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (NDA) for roflumilast cream for the treatment of plaque psoriasis in adults and adolescents Completed enrollment of the sole pivotal Phase 3 trial of roflumilast foam in seborrheic dermatitis
Read more →ARQTArcutis Completes Enrollment of STRATUM Pivotal Phase 3 Trial of Topical Roflumilast Foam in Individuals with Seborrheic Dermatitis
Topline data now anticipated in mid-year 2022, followed by a regulatory submission in first half of 2023 A total of 457 subjects are enrolled in the STRATUM study Seborrheic dermatitis affects 10 million people in the U.S. WESTLAKE VILLAGE, Calif., Feb. 01, 2022 (GLOBE NEWSWIR
Read more →ARQTDocument Arcutis Biotherapeutics Secures $225 Million in Non-Dilutive Debt Financing from SLR Capital Partners
Arcutis Biotherapeutics Secures $225 Million in Non-Dilutive Debt Financing from SLR Capital Partners WESTLAKE VILLAGE, Calif., Dec 23, 2021 - Arcutis Biotherapeutics, Inc. (Nasdaq ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immu
Read more →ARQTArcutis Biotherapeutics Secures $225 Million in Non-Dilutive Debt Financing from SLR Capital Partners
WESTLAKE VILLAGE, Calif., Dec. 23, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that it has obtained a $225 million term loan facil
Read more →ARQTArcutis Appoints Mas Matsuda as General Counsel and Corporate Secretary
WESTLAKE VILLAGE, Calif., Dec. 16, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the appointment of Mas Matsuda, Esq. as General Cou
Read more →ARQTArcutis Announces Data Comparing the Vehicle in Investigational Roflumilast Cream Against a Commercial Ceramide-Containing Moisturizing Cream
Data presented at Revolutionizing Atopic Dermatitis (RAD) Conference Vehicle tested was comparable to the moisturizing cream based on primary endpoint of change in transepidermal water loss (TEWL) from baseline at Day 15 Data provide additional support for ongoing studies of in
Read more →ARQTDocument Arcutis Announces Third Quarter 2021 Financial Results and Provides Business Update Submitted New Drug Application (NDA) for roflumilast cream for the treatment of plaque psoriasis across the full spectrum of di
Arcutis Announces Third Quarter 2021 Financial Results and Provides Business Update Submitted New Drug Application (NDA) for roflumilast cream for the treatment of plaque psoriasis across the full spectrum of disease Initiated single pivotal Phase 3 trial of roflumilast foam in
Read more →ARQTArcutis Announces Third Quarter 2021 Financial Results and Provides Business Update
Submitted New Drug Application (NDA) for roflumilast cream for the treatment of plaque psoriasis across the full spectrum of disease Initiated single pivotal Phase 3 trial of roflumilast foam in scalp and body psoriasis Enrolling pivotal Phase 3 trials of roflumilast cream in a
Read more →ARQTArcutis Submits Topical Roflumilast Cream New Drug Application to FDA for the Treatment of Adults and Adolescents with Plaque Psoriasis
Plaque psoriasis is a skin disease that affects approximately 8.6 million individuals in the U.S. and presents particular treatment challenges in certain anatomical regions. Roflumilast cream, a non-steroidal treatment intended for chronic use, would be the first and only topica
Read more →ARQTArcutis Expands Patent Portfolio with Roflumilast Pharmacokinetics Patent
WESTLAKE VILLAGE, Calif., Sept. 28, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology to address the urgent needs of patients living with immune-mediated
Read more →ARQTArcutis Announces Appointment of Keith Leonard to Board of Directors
WESTLAKE VILLAGE, Calif., Sept. 02, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations to address the urgent needs of patients living with immune-mediated dermatological diseas
Read more →ARQTArcutis Enrolls First Patient in Phase 3 Clinical Trial of Topical Roflumilast Foam (ARQ-154) as a Potential Treatment for Scalp and Body Psoriasis
Topical roflumilast potential “Best-in-Class” topical PDE4 inhibitor Scalp and body psoriasis affects more than 8 million patients in the U.S. WESTLAKE VILLAGE, Calif., Aug. 25, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutica
Read more →ARQTDocument Arcutis Announces Second Quarter 2021 Financial Results and Provides Business Update Anticipates submission of a New Drug Application (NDA) for topical roflumilast cream as a potential treatment for plaque psori
Arcutis Announces Second Quarter 2021 Financial Results and Provides Business Update Anticipates submission of a New Drug Application (NDA) for topical roflumilast cream as a potential treatment for plaque psoriasis late in the third quarter or early in the fourth quarter of 202
Read more →ARQTArcutis Announces Second Quarter 2021 Financial Results and Provides Business Update
Anticipates submission of a New Drug Application (NDA) for topical roflumilast cream as a potential treatment for plaque psoriasis late in the third quarter or early in the fourth quarter of 2021 Initiated single pivotal Phase 3 trial of topical roflumilast foam in seborrheic de
Read more →ARQTArcutis Announces Additions to its Investor Relations and Communications Team
Eric McIntyre joins as Head of Investor Relations Amanda Sheldon joins as Head of Corporate Communications WESTLAKE VILLAGE, Calif., Aug. 02, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing mean
Read more →ARQTArcutis Advances Science of Psoriasis Drug Development with New Precision Method for Measuring Mild-to-Moderate Psoriasis
The majority of patients with psoriasis have mild or moderate levels of disease The new method, PASI-high discrimination (PASI-HD), is designed for use in clinical trials evaluating novel topical treatment options for psoriasis Details of new approach published in Dermatology a
Read more →ARQTArcutis Announces First Patient Enrolled in Phase 3 Clinical Trial of Topical Roflumilast Foam (ARQ-154) as a Potential Treatment for Seborrheic Dermatitis
Topical roflumilast potential “Best-in-Class” topical PDE4 inhibitor Seborrheic dermatitis affects 10 million patients in the U.S. Potential first new topical treatment for seborrheic dermatitis in decades The Company anticipates topline data in the second or third quarter of
Read more →ARQTArcutis Provides Update on Phase 2a Clinical Trial Evaluating ARQ-252 Cream as a Potential Treatment for Vitiligo
Formulation-related observations from ARQ-252 trial in chronic hand eczema informed early termination of Phase 2a ARQ-252 trial in vitiligo Company progressing new formulation with goal of greater drug delivery to targets in the skin WESTLAKE VILLAGE, Calif., July 01, 2021 (GLO
Read more →ARQTArcutis Announces Appointment of Sue-Jean Lin to Board of Directors
WESTLAKE VILLAGE, Calif., June 09, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immu
Read more →ARQTArcutis Biotherapeutics Showcases Pivotal DERMIS-1 and -2 Phase 3 Trial Data for Topical Roflumilast Cream (ARQ-151) in Plaque Psoriasis at EADV Spring Symposium 2021
Data show roflumilast produced robust efficacy compared to vehicle in both Phase 3 studies on the primary efficacy endpoint of IGA success at eight weeks Roflumilast also demonstrated statistically significant improvements over vehicle in the key secondary endpoints of I-IGA suc
Read more →ARQTDocument Arcutis Announces First Quarter 2021 Financial Results and Provides Business Update New Drug Application (NDA) submission for topical roflumilast cream as a potential treatment for plaque psoriasis anticipated i
Arcutis Announces First Quarter 2021 Financial Results and Provides Business Update New Drug Application (NDA) submission for topical roflumilast cream as a potential treatment for plaque psoriasis anticipated in the second half of 2021 Positive Phase 3 results for topical rofl
Read more →ARQTArcutis Announces First Quarter 2021 Financial Results and Provides Business Update
New Drug Application (NDA) submission for topical roflumilast cream as a potential treatment for plaque psoriasis anticipated in the second half of 2021 Positive Phase 3 results for topical roflumilast cream in plaque psoriasis announced in February Advancing topical roflumilas
Read more →ARQTArcutis to Present New Roflumilast Cream Phase 3 Data at The European Academy of Dermatology and Venereology (EADV) Spring Symposium
Presentation will highlight efficacy and safety data from the DERMIS-1 and DERMIS-2 pivotal Phase 3 studies evaluating roflumilast cream (ARQ-151) as a potential topical once-daily treatment for chronic plaque psoriasis WESTLAKE VILLAGE, Calif., May 03, 2021 (GLOBE NEWSWIRE) --
Read more →ARQTArcutis to Present at the 2021 Truist Securities Life Sciences Summit
WESTLAKE VILLAGE, Calif., April 28, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or imm
Read more →ARQTArcutis Biotherapeutics Showcases New Roflumilast Data in Psoriasis and Seborrheic Dermatitis at American Academy of Dermatology (AAD) Virtual Meeting Experience (VMX) 2021
Detailed results from Phase 2b study of roflumilast foam in scalp and body psoriasis featured in late-breaking oral presentation Data demonstrate roflumilast foam was well-tolerated and improved scalp and body psoriasis as early as two weeks after treatment initiation Four addi
Read more →ARQTArcutis Biotherapeutics to Present New Roflumilast Data at The American Academy of Dermatology (AAD) Virtual Meeting Experience (VMX)
WESTLAKE VILLAGE, Calif., April 19, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or imm
Read more →ARQTArcutis Initiates Phase 3 Clinical Trial of Topical Roflumilast Cream (ARQ-151) as a Potential Treatment for Atopic Dermatitis in Pediatric Patients Between the Ages of Two and Five Years
Roflumilast cream potential “Best in Class” topical PDE4 inhibitor Atopic dermatitis affects approximately 19 million patients in the U.S. The Company anticipates topline data in the second half of 2022 WESTLAKE VILLAGE, Calif., April 12, 2021 (GLOBE NEWSWIRE) -- Arcutis Bioth
Read more →ARQTArcutis Announces Updates to its Executive Team
Scott Burrows to succeed John Smither as Chief Financial Officer (CFO) upon Mr. Smither’s retirement Corey Padovano named Vice President of Sales Sean Brugger joins as Executive Director of Field Medical Affairs WESTLAKE VILLAGE, Calif., March 26, 2021 (GLOBE NEWSWIRE) -- Arcu
Read more →ARQTArcutis Announces First Patient Enrolled in Phase 2a Clinical Trial Evaluating ARQ-252 as a Potential Treatment for Vitiligo
ARQ-252 is a potent and highly selective topical JAK1 inhibitor offering potential safety advantages over less selective JAK inhibitors Topline data anticipated second half 2023 Vitiligo affects approximately 1.3 million patients in the U.S. WESTLAKE VILLAGE, Calif., March 18,
Read more →ARQTArcutis Biotherapeutics to Showcase Long-term Safety, Efficacy, and Patient-Reported Outcomes of Roflumilast Cream for Chronic Plaque Psoriasis at Innovations in Dermatology: Virtual Spring Conference 2021
WESTLAKE VILLAGE, Calif., March 17, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or imm
Read more →ARQTArcutis to Present at the Cowen 41st Annual Health Care Conference
WESTLAKE VILLAGE, Calif., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immu
Read more →ARQTDocument Arcutis Announces Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update NDA submission for topical roflumilast cream as a potential treatment for plaque psoriasis anticipated in the se
Arcutis Announces Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update NDA submission for topical roflumilast cream as a potential treatment for plaque psoriasis anticipated in the second half of 2021 Positive Phase 3 data on topical roflumilast crea
Read more →ARQTArcutis Announces Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update
NDA submission for topical roflumilast cream as a potential treatment for plaque psoriasis anticipated in the second half of 2021 Positive Phase 3 data on topical roflumilast cream in plaque psoriasis reported in February Advancing topical roflumilast into Phase 3 programs for
Read more →ARQTArcutis Biotherapeutics Announces Closing of Underwriters’ Over-Allotment Option in Connection with Public Offering of Common Stock
WESTLAKE VILLAGE, Calif., Feb. 16, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (“Arcutis”) (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditi
Read more →ARQTArcutis Biotherapeutics Announces Pricing of Upsized Public Offering of Common Stock
WESTLAKE VILLAGE, Calif,, Feb. 02, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (“Arcutis”) (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditi
Read more →ARQT8xk DERMIS-1/DERMIS-2 Phase 3 Plaque Psoriasis Topline Data Review February 2021 Legal Disclaimers This presentation and the accompanying oral presentation contain "forward-looking" statements that are based on our manag
DERMIS-1/DERMIS-2 Phase 3 Plaque Psoriasis Topline Data Review February 2021 Legal Disclaimers This presentation and the accompanying oral presentation contain "forward-looking" statements that are based on our management's beliefs and assumptions and on information currently av
Read more →ARQTArcutis Announces Positive Topline Results from Pivotal DERMIS-1 and -2 Phase 3 Trials of Topical Roflumilast Cream (ARQ-151) in Plaque Psoriasis
Roflumilast cream demonstrated statistically significant superiority over vehicle on primary endpoint of IGA Success Favorable safety and tolerability profile in this patient population New Drug Application (NDA) submission anticipated in the second half of 2021 Roflumilast cr
Read more →ARQTArcutis to Advance Topical Roflumilast Foam (ARQ-154) into Phase 3 Development for the Treatment of Seborrheic Dermatitis
Phase 3 development to consist of single pivotal trial Previously reported data demonstrated that roflumilast foam provided statistically significant improvement and a favorable safety and tolerability profile Roflumilast foam potential “Best in Class” topical PDE4 inhibitor S
Read more →ARQTArcutis Initiates Pivotal Phase 3 Clinical Trials Evaluating Topical Roflumilast Cream (ARQ-151) as a Potential Treatment for Atopic Dermatitis
Roflumilast cream potential “Best in Class” topical PDE4 inhibitor Atopic dermatitis affects approximately 19 million patients in the U.S. The Company anticipates topline data in the second half of 2022 WESTLAKE VILLAGE, Calif., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Arcutis Biothe
Read more →ARQTArcutis Biotherapeutics Added to Nasdaq Biotechnology Index
WESTLAKE VILLAGE, Calif., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immu
Read more →ARQTArcutis Highlights Advanced Pipeline & Unique Immuno-Dermatology Drug Development Capabilities at Virtual Investor Day on December 9, 2020
Broad and deep portfolio of highly differentiated product candidates aligned with needs of patients and doctors Robust pipeline includes 4 development programs addressing 7 dermatological diseases, including 3 programs in Phase 2 or Phase 3 for 5 different indications Pipeline
Read more →ARQTArcutis Announces Last Patient Completes Final Study Visit in DERMIS-1 and DERMIS-2 Pivotal Phase 3 Clinical Trials Evaluating ARQ-151 (Topical Roflumilast Cream) as a Potential Treatment for Plaque Psoriasis
Phase 3 trials’ topline data anticipated in the first quarter of 2021 and potential New Drug Application (NDA) submission anticipated by the end of 2021 Roflumilast cream potential “Best in Class” topical PDE4 inhibitor Plaque psoriasis affects approximately 8.6 million patient
Read more →ARQTArcutis to Host Virtual Investor Day on Wednesday, December 9, 2020
WESTLAKE VILLAGE, Calif., Dec. 02, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immu
Read more →ARQTArcutis Announces Positive Topline Data from Phase 2b Study of ARQ-154 (Topical Roflumilast Foam) as a Potential Treatment for Scalp and Body Psoriasis Roflumilast foam demonstrated statistically significant improvement
Arcutis Announces Positive Topline Data from Phase 2b Study of (Topical Roflumilast Foam) as a Potential Treatment for Scalp and Body Psoriasis Westlake Village, CA, Nov. 23, 2020 Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on d
Read more →ARQTArcutis Biotherapeutics to Present at the Stifel 2020 Virtual Healthcare Conference
WESTLAKE VILLAGE, Calif., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immu
Read more →ARQTDocument Arcutis Announces Third Quarter 2020 Financial Results and Provides Business Update Pivotal Phase 3 data in plaque psoriasis anticipated in first quarter of 2021 Pivotal Phase 3 trials in atopic dermatitis antic
Arcutis Announces Third Quarter 2020 Financial Results and Provides Business Update Pivotal Phase 3 data in plaque psoriasis anticipated in first quarter of 2021 Pivotal Phase 3 trials in atopic dermatitis anticipated to begin in late 2020 or early 2021 Recent positive Phase 2
Read more →ARQTArcutis Announces Third Quarter 2020 Financial Results and Provides Business Update
Pivotal Phase 3 data in plaque psoriasis anticipated in first quarter of 2021 Pivotal Phase 3 trials in atopic dermatitis anticipated to begin in late 2020 or early 2021 Recent positive Phase 2 data in seborrheic dermatitis supports pipeline advancement in indication that impac
Read more →ARQTArcutis Announces Appointment of Terrie Curran to Board of Directors Westlake Village, CA
Arcutis Announces Appointment of Terrie Curran to Board of Directors Westlake Village, CA, Nov. 4, 2020 Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and con
Read more →ARQTArcutis Biotherapeutics Presents New Positive Data from Phase 2 Studies of ARQ-151 (Topical Roflumilast Cream) in Chronic Plaque Psoriasis and Atopic Dermatitis
In Phase 2b study of patients with plaque psoriasis, roflumilast cream demonstrated rapid and clinically significant reduction in the severity and burden of itch and itch-related sleep loss as well as rapid improvement in patient-reported symptom burden Phase 2 proof-of-concept
Read more →ARQTArcutis Biotherapeutics to Present New Data from ARQ-151 (Topical Roflumilast Cream) Clinical Program at Three Global Dermatology Conferences
Data highlight potential of roflumilast cream as a “Best in Class” topical PDE4 inhibitor for the treatment of atopic dermatitis and plaque psoriasis Two oral presentations and one poster at the European Academy of Dermatology and Venereology Virtual Congress Data to also be fe
Read more →ARQTArcutis Completes Enrollment in Phase 1/2b Study Evaluating ARQ-252 in Chronic Hand Eczema
ARQ-252 is a potent and highly selective topical JAK1 inhibitor offering potential safety advantages over less selective JAK inhibitors Hand eczema is the most common skin disease affecting the hands, impacting more than 8 million Americans Topline data now anticipated by mid-2
Read more →ARQTArcutis Biotherapeutics Announces Closing of Public Offering and Concurrent Private Placement of Common Stock
WESTLAKE VILLAGE, Calif., Oct. 06, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immu
Read more →ARQTArcutis Biotherapeutics Announces Pricing of Public Offering and Concurrent Private Placement of Common Stock
WESTLAKE VILLAGE, Calif., Oct. 01, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immu
Read more →ARQTArcutis Biotherapeutics Announces Proposed Public Offering and Concurrent Private Placement of Common Stock
WESTLAKE VILLAGE, Calif., Sept. 29, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or imm
Read more →ARQTSeborrheic Dermatitis September 2020 Legal Disclaimers This presentation and the accompanying oral presentation contain "forward-looking" statements that are based on our management's beliefs and assumptions and on infor
Legal Disclaimers This presentation and the accompanying oral presentation contain "forward-looking" statements that are based on our management's beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other
Read more →ARQTArcutis Announces Positive Topline Data from Phase 2 Clinical Trial Evaluating ARQ-154 (Topical Roflumilast Foam) as a Potential Treatment for Seborrheic Dermatitis
Roflumilast foam demonstrated statistically significant improvement over the vehicle foam on the trial’s primary and multiple secondary endpoints Once-daily roflumilast foam demonstrated a favorable safety and tolerability profile Roflumilast foam potential “Best in Class” topi
Read more →ARQTArcutis Completes Enrollment in DERMIS-1 and DERMIS-2 Pivotal Phase 3 Clinical Trials Evaluating ARQ-151 (Topical Roflumilast Cream) as a Potential Treatment for Plaque Psoriasis
Roflumilast cream potential “Best in Class” topical PDE4 inhibitor Plaque psoriasis affects approximately 8.6 million patients in the U.S. Phase 3 trials topline data now anticipated in the first quarter of 2021 and New Drug Application (NDA) submission anticipated by the end o
Read more →ARQTArcutis to Present at the Cantor Fitzgerald Global Healthcare Conference 2020
WESTLAKE VILLAGE, Calif., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or imm
Read more →ARQTArcutis Biotherapeutics to Accelerate ARQ-151 (Topical Roflumilast Cream) into Phase 3 Trials for the Treatment of Atopic Dermatitis Following End-of-Phase 2 Meeting with FDA
Progression to Phase 3 clinical trials represents significant acceleration of atopic dermatitis development program Previously reported data demonstrated evidence that roflumilast cream provided symptomatic improvement and a favorable tolerability profile Roflumilast cream is a
Read more →ARQTArcutis Announces Second Quarter 2020 Financial Results and Provides Business Update
Robust pipeline anticipated to deliver two Phase 3 and four Phase 2 data events in 2020 and 2021 Arcutis currently expects no impact to its previously disclosed clinical timelines due to COVID-19 Arcutis development programs address dermatological diseases impacting over 20 mil
Read more →ARQTArcutis to Present at the Wedbush PacGrow Healthcare Conference
WESTLAKE VILLAGE, Calif., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immu
Read more →ARQTPreliminary Data from Long-Term Safety Study Support Chronic Use of ARQ-151 (Topical Roflumilast Cream) as a Potential Treatment for Plaque Psoriasis ----------------------------------------------------------------------
Preliminary Data from Long-Term Safety Study Support Chronic Use of ARQ-151 (Topical Roflumilast Cream) as a Potential Treatment for Plaque Psoriasis ------------------------------------------------------------------------------------------------------------------- Once-daily
Read more →ARQTArcutis Appoints Patrick Burnett, M.D., Ph.D., FAAD, as Chief Medical Officer
Experienced industry leader to head Arcutis’ clinical development programs Appointment aligns with Arcutis’ strategy of building a team with deep dermatology expertise Howard Welgus, M.D., FAAD to retire; elected to Arcutis’ Board of Directors WESTLAKE VILLAGE, Calif., July 27
Read more →ARQTArcutis Enrolls Last Patient in Phase 2b Clinical Trial Evaluating ARQ-154 (Topical Roflumilast Foam) as a Potential Treatment for Scalp Psoriasis
Roflumilast foam potential “Best in Class” topical PDE4 inhibitor in foam formulation Scalp psoriasis affects more than 2.5 million U.S. patients Phase 2b topline data anticipated fourth quarter 2020 WESTLAKE VILLAGE, Calif., July 20, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherap
Read more →ARQTArcutis Initiates Patient Enrollment in the Phase 2b Portion of the Phase 1/2b Study Evaluating ARQ-252 in Chronic Hand Eczema
ARQ-252 is a potent and highly selective topical JAK1 inhibitor offering potential safety advantages over less selective JAK inhibitors Company expects topline data in the second half of 2021 WESTLAKE VILLAGE, Calif., July 13, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, I
Read more →ARQTArcutis Enrolls Last Patient in Phase 2 Proof of Concept Clinical Trial Evaluating ARQ-154 (Topical Roflumilast Foam) as a Potential Treatment for Seborrheic Dermatitis
Roflumilast foam potential “Best in Class” topical PDE4 inhibitor in foam formulation Seborrheic dermatitis affects over 6 million U.S. patients Phase 2 topline data anticipated early in fourth quarter of 2020 The Company also announced first patient enrolled in long-term safe
Read more →ARQTArcutis to Present at the Goldman Sachs 41st Annual Global Health Care Conference
WESTLAKE VILLAGE, Calif., June 10, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immu
Read more →ARQTArcutis Announces First Quarter 2020 Financial Results and Provides Business Update Multiple important Phase 3 and Phase 2 data events anticipated during 2020/2021 Arcutis currently expects no impact to its previously di
Arcutis Announces First Quarter 2020 Financial Results and Provides Business Update Westlake Village, CA, May 12, 2020 Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in im
Read more →ARQTHalley E. Gilbert Appointed to Arcutis Board of Directors Westlake Village, CA
Halley E. Gilbert Appointed to Arcutis Board of Directors Westlake Village, CA, April 27, 2020 Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatolog
Read more →ARQTArcutis Announces Enrollment of First Patient in Phase 1/2b Study of ARQ-252 in Patients with Chronic Hand Eczema
ARQ-252 is a Potent Topical Small Molecule Inhibitor of JAK1 High Selectivity for JAK1 over JAK2 JAK Inhibition a Biologically Validated Target for Treatment of Hand Eczema WESTLAKE VILLAGE, Calif., April 21, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT
Read more →ARQTArcutis Announces Inclusion of Children in On-going Pivotal Phase 3 Clinical Trials Evaluating Topical Roflumilast (ARQ-151) as a Potential Once Daily Topical Treatment for Plaque Psoriasis
FDA requests study amendment to allow inclusion of children ages 2 to 11 years in the DERMIS-1 and DERMIS-2 trials Strong safety profile supported population expansion in pivotal Phase 3 trials Topical Roflumilast potential “Best in Class” topical PDE4 inhibitor Phase 3 trials
Read more →ARQTArcutis Announces Data from the Phase 2b Study of Topical Roflumilast Cream in Patients with Plaque Psoriasis Selected for Late-Breaking Oral Presentation at the American Academy of Dermatology (AAD) Annual Meeting
WESTLAKE VILLAGE, Calif., March 03, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or imm
Read more →ARQTArcutis to Present at the Cowen 40th Annual Health Care Conference
WESTLAKE VILLAGE, Calif., Feb. 19, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immu
Read more →ARQTArcutis Announces Enrollment of First Patient in Topical Roflumilast Cream Phase 3 Open Label Extension Study in Plaque Psoriasis
Topical Roflumilast Cream (ARQ-151) Potential “Best in Class” Topical PDE4 inhibitor Roflumilast Cream Potentially Only Topical PDE4 inhibitor for Psoriasis Open Label Extension Study to Support Potential Recommendations for Long-term Use of Roflumilast Cream WESTLAKE VILLAGE,
Read more →ARQTArcutis Announces Closing of Initial Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares
WESTLAKE VILLAGE, Calif., Feb. 04, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immu
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