FDA Calendar 2026 Upcoming FDA Approval Dates & PDUFA Dates
Track every upcoming FDA approval date, PDUFA date, and biotech catalyst in one place. Our free FDA calendar is updated daily with clinical trial readouts, advisory committee meetings, drug approval decisions, and next FDA meeting dates for 2026. Built for biotech investors who need to stay ahead of stock-moving regulatory events.
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Showing 6 Catalysts Out Of 978. Click On The Tickers For More Details
Deucrictibant immediate-release capsule (PHVS416) is Pharvaris’s oral, selective bradykinin B2 receptor antagonist designed for the on-demand treatment of hereditary angioedema (HAE) attacks. The program has progressed to phase 3, with the pivotal on-demand study known as RAPIDe-3 (NCT06343779), which is a randomized, double-blind, placebo-controlled trial involving adolescents and adults with HAE, including HAE-C1INH type 1/2 and HAE with normal C1 inhibitor. Participants in this study self-administered either deucrictibant IR 20 mg or placebo to address qualifying attacks. The study successfully met its primary and all 11 secondary endpoints, indicating a robust efficacy profile. Earlier evidence from phase 2 was derived from RAPIDe-1 (NCT04618211), a double-blind, placebo-controlled, randomized, crossover, dose-ranging trial focused on HAE-1/2. In RAPIDe-1, deucrictibant demonstrated a significant reduction in the time to onset of symptom relief, time to resolution, and a decrease in rescue medication usage. A post hoc analysis revealed a median time to end of progression of 25–26 minutes compared to 20 hours with placebo, with 78.4%, 89.3%, and 93.5% of attacks resolved within 24 hours at doses of 10, 20, and 30 mg, respectively, versus 29.4% with placebo. The topline results from the phase 3 RAPIDe-3 trial further support the drug's efficacy, reporting an onset of symptom relief at 4 hours of 83.1% for deucrictibant compared to 27.6% for placebo. Publicly available materials suggest that the program is characterized by a rapid onset and a well-tolerated profile, with no major safety concerns disclosed. However, it is important to note that the dataset remains incomplete, as full numerical safety tables, subgroup analyses, and detailed discontinuation data were not provided in the sources reviewed. In terms of regulatory designations, deucrictibant has received orphan drug designation from the U.S. FDA for bradykinin-mediated angioedema and European orphan designation. However, the available sources do not indicate that the drug has been granted Fast Track, Breakthrough Therapy, Priority Review, or Accelerated Approval specifically for HAE attacks. Mechanistically, deucrictibant is distinct from existing acute HAE therapies, as it is an oral bradykinin-pathway antagonist rather than an injectable rescue therapy, positioning it as first-in-class for oral B2 receptor antagonism in the treatment of HAE attacks. The competitive landscape for HAE treatments is robust, with established on-demand options such as icatibant, ecallantide, and C1 esterase inhibitor products, alongside evolving pipeline and prophylaxis strategies. The unmet need in this space is significant, as HAE attacks are episodic, urgent, and burdensome. The convenience of oral self-administration could offer a substantial advantage in terms of patient adherence. Historical precedents suggest that the FDA will prioritize attack-level efficacy, speed of onset, durability of benefit, and safety consistency in its evaluations. Recent HAE programs have generally succeeded when they provided clear symptom relief with acceptable tolerability, while those with insufficient efficacy or safety concerns have faced challenges. Pharvaris's development track record is mixed but credible, and the sources reviewed do not indicate prior FDA approvals or rejections for this program. Overall, while the phase 3 signal appears strong, the estimated probability of approval stands at 67.0%. This figure reflects the potential challenges posed by limited public safety data and the competitive nature of the HAE on-demand therapy market, which demands clinically meaningful outcomes. Read More
Divesiran (SLN124) is a first-in-class GalNAc-conjugated small interfering RNA (siRNA) developed by Silence Therapeutics (NASDAQ: SLN) for the treatment of polycythemia vera (PV), a rare myeloproliferative neoplasm. The drug targets TMPRSS6, a negative regulator of hepcidin, to increase hepcidin production and suppress red blood cell production, thereby addressing the underlying pathophysiology of PV. This innovative mechanism distinguishes divesiran from existing therapies that primarily inhibit the JAK2 pathway. The global market for polycythemia vera is estimated to be between $1.2 billion and $1.8 billion, driven by a patient population of approximately 100,000 to 150,000 worldwide. There is a significant unmet medical need in this area, as current first-line management relies heavily on phlebotomy, an invasive and burdensome procedure. Existing pharmacological options, including hydroxyurea, ruxolitinib, and peginterferon alfa-2a, face challenges such as resistance, variable efficacy, and toxicity concerns. Divesiran aims to alleviate these issues by providing a subcutaneously administered treatment that reduces the frequency of phlebotomy. Currently, divesiran is in Phase 1/2 clinical development, with results from the SANRECO trial (NCT05499013) showing promising outcomes. The open-label, dose-escalation study has enrolled 21 patients across three dose cohorts (3, 6, and 9 mg/kg), with administration every six weeks for four doses. The trial includes a 34-week treatment period followed by a 16-week follow-up, focusing on safety, tolerability, and preliminary efficacy. The efficacy data from Phase 1 are compelling, demonstrating a 94% reduction in phlebotomy frequency—from 79 phlebotomies pre-treatment to just 5 during treatment and 2 to 4 during follow-up. Notably, three patients with baseline hematocrit levels below 45% required no phlebotomies post-treatment. Mean hematocrit levels decreased across all dose cohorts, with sustained reductions observed through Day 232. Additionally, hepcidin induction was confirmed in all patients, and ferritin levels increased, indicating improved iron metabolism. Hematological parameters remained stable, with platelet counts increasing and white blood cell counts stable across cohorts. The safety profile of divesiran is exceptional for a Phase 1 study, with 83% of treatment-emergent adverse events classified as Grade 1 (mild). The most common adverse event was injection site reaction, affecting 66.7% of patients. Importantly, no dose-limiting toxicities, serious adverse events, or treatment-related discontinuations were reported, significantly de-risking the development program. Divesiran is classified as a first-in-class therapy, with no other approved drugs targeting TMPRSS6 for any indication. Although polycythemia vera qualifies for orphan drug status, there is no documented evidence of Fast Track, Breakthrough Therapy, or Priority Review designations for divesiran, indicating that the FDA views this development as standard. The competitive landscape includes approved therapies such as ruxolitinib, peginterferon alfa-2a, and hydroxyurea, as well as pipeline competitors. However, divesiran's novel mechanism, outstanding safety profile, and convenient dosing regimen (every six weeks) provide a distinct advantage over existing options. Historical precedents, such as ruxolitinib's approval based on Phase 2 data for myelofibrosis and subsequent approval for PV, underscore the importance of demonstrating a favorable safety-efficacy balance for FDA approval. The probability of approval (PoA) for divesiran is estimated to be between 32% and 42%. This estimate reflects a balanced risk-benefit assessment. Positive factors include the exceptional safety profile observed in Phase 1, a clear efficacy signal with significant reductions in phlebotomy frequency, confirmed target engagement, and the first-in-class mechanism addressing a substantial unmet need. However, challenges remain, including the early development stage, small sample size, open-label design, and the absence of expedited regulatory designations, which may necessitate Phase 3 trials. Investors should consider divesiran as a high-risk, high-reward opportunity. If successful, it could establish a first-in-class, differentiated therapy in an underserved rare disease market with significant commercial potential. However, the early development stage, regulatory uncertainties, and sponsor scale present material risks. Upcoming catalysts, including Phase 2 initiation and interim data, will be crucial in validating the investment thesis. In conclusion, divesiran represents a promising advancement in the treatment of polycythemia vera, with the potential to transform patient management through its innovative mechanism and favorable safety profile. The ongoing clinical development will be closely monitored as it progresses toward potential regulatory approval. Read More
Etentamig (ABBV-383) is an investigational BCMAxCD3 bispecific antibody developed by AbbVie for the treatment of relapsed/refractory immunoglobulin light chain (AL) amyloidosis, a rare plasma-cell disorder characterized by the deposition of toxic light chains in various organs. The current development program is in an open-label phase 1/2 study known as M24-209, which is registered in Japan under jRCT2071230131 and cross-referenced to NCT06158854. This study aims to evaluate the safety and efficacy of etentamig in patients with AL amyloidosis. The design of the study consists of two parts: dose escalation followed by dose expansion. However, available public sources do not indicate any randomization, placebo control, or blinding, which aligns with the exploratory nature of this early-stage trial. As of the analysis date, there are no published efficacy results for AL amyloidosis from this program, including overall response rate (ORR), progression-free survival (PFS), overall survival (OS), hazard ratios, p-values, or confidence intervals. This lack of data limits confidence in estimating the probability of approval (PoA), which is currently set at 18.0%. Consequently, the assessment relies heavily on class-level logic and the maturity of the program. A significant safety concern arises from the underlying mechanism of ABBV-383 as a T-cell engager, which is associated with risks such as cytokine release syndrome (CRS), infections, and cytopenias. While pooled phase 1 data from multiple myeloma suggest a manageable safety profile, with low incidences of grade 3/4 infections and durable responses, these results are not directly applicable to AL amyloidosis and should be viewed as supportive rather than predictive. Regarding regulatory designations for relapsed/refractory AL amyloidosis, there is no evidence of FDA Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval status for this indication. Although AbbVie may hold orphan status or other designations for different indications within its portfolio, these do not apply to this specific program. The absence of indication-specific designations modestly reduces the PoA, although the rarity and severity of AL amyloidosis could still support expedited regulatory pathways if compelling organ-response data emerge. From a commercial perspective, the market for relapsed/refractory AL amyloidosis is relatively small, with an estimated global drug sales opportunity of approximately $0.3 billion. This figure reflects the rarity of the disease and the limited treatable population. The unmet need is significant, as relapse following treatment with proteasome inhibitors, anti-CD38 therapies, alkylators, and stem-cell approaches is common, and there is currently no established disease-specific standard for refractory cases. Mechanistically, etentamig is positioned as a first-in-class therapy for AL amyloidosis, as BCMA-directed T-cell redirection is novel in this context, even though it is not unprecedented across hematologic malignancies. AbbVie has a mixed but generally credible development track record, with a strong history of late-stage approvals in immunology, oncology, and neuroscience. However, ABBV-383 remains an investigational asset without prior approvals in AL amyloidosis. The program benefits from AbbVie’s experience in bispecifics and oncology execution. Historical precedents indicate that FDA decisions in this therapeutic area are heavily influenced by durable hematologic responses, organ-response evidence, tolerability in frail patients, and effective management of infections and CRS. Given these considerations, the mid-teens PoA is deemed appropriate until the program can demonstrate convincing efficacy and safety specific to AL amyloidosis. Read More
Venetoclax (VENCLEXTA®), marketed by AbbVie, is an oral BCL-2 inhibitor that induces apoptosis in chronic lymphocytic leukemia (CLL) cells by antagonizing the anti-apoptotic BCL-2 protein. As a first-in-class agent, it was the first BCL-2 inhibitor approved for CLL and continues to define the mechanistic landscape of this therapeutic class. The current development status for previously untreated CLL indicates that the drug is effectively approved rather than still in Phase 3 trials. The Phase 3 AMPLIFY trial (NCT03836261) supported FDA approval of the fixed-duration combination of venetoclax and acalabrutinib in February 2026 for adults with previously untreated CLL/SLL. This regimen represents the first all-oral, fixed-duration first-line CLL option approved in the U.S. The AMPLIFY trial was a randomized Phase 3 study that compared the venetoclax-acalabrutinib combination against standard chemoimmunotherapy regimens (FCR or BR, depending on patient characteristics). According to communications from AbbVie and the FDA, the combination demonstrated a 35% reduction in the risk of disease progression or death compared to chemoimmunotherapy, with a hazard ratio of 0.65 (95% CI 0.49–0.87; p=0.0038). However, publicly available data do not provide a complete overview of the overall response rate (ORR), progression-free survival (PFS), or overall survival (OS) metrics, and OS data remains immature or unreported. Safety profiles for the first-line combination were consistent with known effects, reporting a tumor lysis syndrome incidence of 0.3% and no new safety signals. In terms of regulatory designations for previously untreated CLL, the combination has received orphan drug designation, while Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval designations were not supported for this indication. It is important to note that earlier breakthrough, priority, or accelerated approvals for venetoclax were granted for different indications and do not apply here. The market for CLL treatment is substantial, with a global market size estimated at $8.5 billion. Despite improvements in outcomes with BTK inhibitors and fixed-duration venetoclax-based regimens, there remains a significant unmet need for deeper and more durable remissions, lower cumulative toxicity, and time-limited therapy options that alleviate long-term treatment burdens. The competitive landscape for first-line CLL therapies is intense, primarily dominated by BTK inhibitors and their combinations. Venetoclax's strategic advantage lies in its ability to provide time-limited, deep-remission therapy, addressing a pressing unmet need, as many patients still require prolonged treatment and face cumulative toxicity. Key risks associated with the venetoclax-acalabrutinib regimen include safety concerns related to class effects, particularly tumor lysis syndrome and myelosuppression, which could impact market uptake and labeling. Additionally, competitive displacement from BTK inhibitor-based regimens and newer combinations may limit commercial potential even post-approval. There is also a risk of an evidence ceiling, where the long-term overall survival or minimal residual disease (MRD) depth advantages may not continue to mature favorably, narrowing the program's differentiation. Upcoming catalysts include additional overall survival and duration-of-response updates from the AMPLIFY trial, as well as regulatory and health technology assessment decisions in Europe and other regions for the venetoclax-acalabrutinib combination. The timing for these updates has not been disclosed. Given AbbVie's strong regulatory track record with venetoclax in CLL, the robust basis of the randomized Phase 3 trial, the clinically meaningful PFS benefit observed, and the absence of new major safety signals, the probability of approval (PoA) for the previously untreated CLL program is estimated at 99.0%. This assessment acknowledges that the program is already approved in the U.S., with remaining risks primarily related to post-approval commercial dynamics and label expansion rather than binary approval risks. Read More
Obicetrapib Safety in patients treated for elevated LDL-C / hypercholesterolemia
Phase 3
78%
Obicetrapib is an oral, once-daily, highly selective CETP inhibitor developed by NewAmsterdam Pharma, aimed at lowering LDL-C levels in patients with elevated LDL-C, particularly those with atherosclerotic cardiovascular disease (ASCVD) and familial hypercholesterolemia (HeFH) who have not achieved target levels despite maximally tolerated therapy. Currently, the drug is in Phase 3 clinical development, with pivotal studies including BROADWAY (NCT05142722), BROOKLYN (NCT05425745), and the ongoing outcomes program PREVAIL. BROADWAY was a randomized, double-blind, placebo-controlled trial involving 2,530 patients with ASCVD and/or HeFH, where obicetrapib demonstrated a significant LDL-C reduction of 33% compared to placebo at day 84 (P<0.0001). Similarly, BROOKLYN, also randomized and placebo-controlled, reported a placebo-adjusted LDL-C reduction of 36.3% at week 12 and 41.5% at week 52, both with P-values less than 0.0001. Safety data from these trials indicate that obicetrapib is well tolerated, with a safety profile comparable to placebo. Notably, no concerning blood-pressure signals were observed in the BROOKLYN study. The market opportunity for obicetrapib is substantial, with a global market size exceeding $20 billion. There remains a significant unmet need, as many high-risk patients with ASCVD, HeFH, or persistent hypercholesterolemia fail to reach guideline LDL-C targets despite existing therapies, including statins, ezetimibe, and PCSK9 inhibitors. The potential for an effective oral LDL-C lowering agent is clinically valuable in addressing this gap. Obicetrapib is classified as best-in-class rather than first-in-class, as CETP inhibition is not a novel mechanism. However, it appears to be the first CETP inhibitor with a credible late-stage efficacy and safety profile following previous class disappointments. In terms of regulatory designations, obicetrapib does not currently have any FDA fast track, breakthrough, orphan, priority review, or accelerated approval designations associated with its indication for safety in patients treated for elevated LDL-C and hypercholesterolemia. This lack of designations could impact the drug's market entry timeline and overall commercialization strategy. The estimated probability of approval (PoA) for obicetrapib stands at 78.0%. This estimate is bolstered by consistent LDL-C lowering results across Phase 3 trials, a favorable safety profile, and the maturity of its late-stage development. However, key risks remain, including the uncertainty surrounding definitive cardiovascular outcomes data, competitive pressures from established lipid-lowering therapies, and historical skepticism regarding the CETP inhibitor class. Previous failures in this class, such as torcetrapib and evacetrapib, were largely due to safety or efficacy concerns, contrasting with the success of newer lipid-lowering agents like bempedoic acid, PCSK9 therapies, and inclisiran, which have demonstrated either outcome benefits or strong LDL-C lowering with acceptable safety profiles. Upcoming catalysts for obicetrapib include the readout of the PREVAIL Phase 3 outcomes trial, potential NDA filing and regulatory submissions, and additional updates from ongoing registrational studies. The competitive landscape will be critical as obicetrapib seeks to establish its position in a crowded market of lipid-lowering therapies. Read More
Obicetrapib Pharmacokinetics and safety in moderate hepatic impairment
Phase 1
96%
Obicetrapib is an investigational, highly selective cholesteryl ester transfer protein (CETP) inhibitor developed by NewAmsterdam Pharma, ticker NAMS. It is primarily intended as an adjunct LDL-C-lowering therapy for patients with dyslipidemia and atherosclerotic cardiovascular disease (ASCVD). The focus of this analysis is on the pharmacokinetics and safety of obicetrapib in individuals with moderate hepatic impairment, which is currently in Phase 1 of clinical development. The market analysis indicates that the market size for this specific indication is approximately $0.1 billion globally. While there is an unmet clinical need to understand dosing, exposure, and safety in patients with moderate hepatic impairment—due to the potential for hepatic dysfunction to alter drug clearance and tolerability—this study is classified as a narrow enabling pharmacokinetic and safety evaluation rather than a commercial therapeutic indication. The drug is categorized as "me-too," reflecting its position within a class of CETP inhibitors that have been previously explored, including torcetrapib, dalcetrapib, anacetrapib, and evacetrapib. Obicetrapib's clinical status is currently in Phase 1, with the trial identified as NCT06048302. This open-label, single-dose, parallel-group study compares participants with moderate hepatic impairment to those with normal hepatic function following a single oral dose of 10 mg. The study enrolls 18 participants and aims to evaluate plasma pharmacokinetics and safety. It is important to note that no efficacy outcomes such as overall response rate (ORR), progression-free survival (PFS), or overall survival (OS) are applicable, as this is not an oncology efficacy program. The key readouts from this study will focus on pharmacokinetic parameters, particularly exposure and safety/tolerability. Previous data suggest that obicetrapib has a long half-life, with a mean terminal half-life of approximately 131 hours at a 10 mg dose, and no clinically relevant accumulation observed in prior studies. This supports the potential for once-daily dosing in later-phase dyslipidemia trials. Regarding regulatory designations for moderate hepatic impairment, there is no public evidence of Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval status for this indication. Such designations would need to be specifically tied to the program in question rather than to obicetrapib's broader LDL-lowering development. The risks associated with this program include the potential for increased drug exposure in patients with hepatic impairment, which could necessitate labeling restrictions or dose adjustments if pharmacokinetics change significantly. Additionally, safety and tolerability findings in the hepatic impairment cohort may reveal higher adverse event rates compared to healthy subjects. The program's regulatory dependence is also noteworthy, as this Phase 1 study serves as an enabling study for a broader lipid program rather than a standalone efficacy trial. Upcoming catalysts include the results from the Phase 1 hepatic impairment study and the interpretation of labeling and pharmacokinetics for special populations, although specific timing for these events has not been disclosed. Despite the challenges, the estimated probability of approval (PoA) for this specific Phase 1 study is high at 96.0%. This is attributed to the study's small size, straightforward mechanistic approach, and the fact that it is already underway. The primary uncertainty lies in the extent of any pharmacokinetic changes rather than the feasibility of completing the study. Read More
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