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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.
Updated daily · Last refreshed Jul 28, 2026
Showing 6 Catalysts Out Of 1206. Click On The Tickers For More Details
| Company | Price | 30-Day Trend | Market Cap | Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Implied Move | Insiders | Hedge Funds | Risk | Cash | Burn Rate | Volume | Float Short | Source |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 CAPRCapricor Therapeutics, Inc. | 5.76 -17.73% | -72.9% | 1.67 B | Advisory Committee (AdCom) 2026-07-29 | Phase 3 | 72% Deramiocel (CAP-1002) is an innovative allogeneic cardiosphere-derived cell therapy developed by Capricor Therapeutics for the treatment of Duchenne muscular dystrophy (DMD). This first-in-class therapy aims to address both the decline of skeletal muscle and the cardiomyopathy associated with DMD, rather than focusing solely on dystrophin restoration. Currently, the program is undergoing late-stage regulatory review in the United States, with the Biologics License Application (BLA) under review by the FDA. The target action date for the FDA's decision is set for August 22, 2026. The pivotal study supporting Deramiocel is the HOPE-3 trial (NCT05126758), a multicenter, randomized, double-blind, placebo-controlled Phase 3 study involving both ambulatory and non-ambulatory patients with DMD. The trial has enrolled 106 randomized subjects, with the primary endpoint being the PUL v2.0 total score and a key secondary endpoint of left ventricular ejection fraction (LVEF). Preliminary results indicate that the trial met its primary endpoint, as well as the cardiac secondary endpoint, with statistically significant outcomes reported in topline disclosures (PUL v2.0 p=0.029; LVEF p=0.041). Additional data presentation highlighted a ~54% reduction in upper-limb functional decline and a ~91% reduction in cardiac decline, alongside a significant effect on the “eat 10 bites” task (p=0.018). Safety profiles have been reported as favorable, consistent with prior experiences, showing no imbalance in serious adverse events and no new safety signals emerging in public disclosures. Regulatory designations for Deramiocel in the context of DMD include Orphan Drug status, while the therapy does not currently qualify for Fast Track, Breakthrough Therapy, Priority Review, or Accelerated Approval designations. The market potential for DMD treatments is substantial, estimated at approximately $13.8 billion globally. This is particularly relevant given the high unmet need in the DMD landscape, where existing therapies only modestly slow disease progression, fail to restore dystrophin in most patients, and do not adequately address the needs of patients experiencing later-stage skeletal and cardiac decline. Deramiocel's classification as first-in-class is noteworthy, as it employs a unique cell-based mechanism that distinguishes it from other approved therapies for DMD. Its dual benefit targeting both skeletal and cardiac aspects of the disease positions it favorably in a competitive landscape that includes exon-skipping drugs and gene therapies, which are often mutation-specific and may face challenges related to durability and manufacturing. In contrast, Deramiocel is designed to be genotype-agnostic and is particularly aimed at patients with later-stage disease. Despite the promising data and regulatory designations, there are key risks associated with Deramiocel's approval. These include regulatory risks stemming from a previous Complete Response Letter (CRL) issued by the FDA in July 2025, which indicated that the BLA did not yet meet the requirements for substantial evidence of efficacy. The approval case heavily relies on the HOPE-3 trial, with limited external confirmatory evidence for this specific cell-therapy approach. Additionally, the competitive landscape poses commercial risks, as DMD already has several approved treatments and an active pipeline, necessitating differentiation in terms of functional and cardiac benefits, durability, and real-world practicality. In summary, the estimated probability of approval for Deramiocel stands at 72.0%. The combination of a positive Phase 3 dataset, a clear unmet need, and orphan regulatory advantages supports this assessment, although the novelty of the therapy and previous regulatory challenges temper the outlook. Read More | – | -9.09 M | 9 +31% | HEALTHY | 278.61 | 9.75 | 6.81 M | 29.78% | |||
 OTLKOutlook Therapeutics, Inc. | 0.825 -22.72% | -12.7% | 37.46 M | PDUFA Date 2026-07-29 | PDUFA | 65% Outlook Therapeutics (OTLK) is advancing ONS-5010/LYTENAVA™ (bevacizumab-vikg), an innovative ophthalmic formulation of bevacizumab intended for intravitreal injection in the treatment of wet age-related macular degeneration (nAMD). This drug is positioned as a best-in-class candidate, capitalizing on the established efficacy of bevacizumab (Avastin) while providing an on-label, FDA-approved alternative to the current reliance on off-label repackaged products in the United States. The global market for wet AMD is projected to reach approximately $15 billion, driven by the high prevalence of the disease and the frequent need for anti-VEGF therapies. A significant unmet need exists in the U.S. due to the lack of an FDA-approved bevacizumab formulation for retinal disease, presenting a substantial commercial opportunity for the first approved product in this category. Currently, ONS-5010 is in the PDUFA phase, with the FDA's target action date set for December 31, 2025. The development program encompasses two pivotal registration trials: NORSE ONE, a clinical experience trial, and NORSE TWO, a 227-patient Phase 3 superiority trial. The primary endpoint for NORSE TWO is the difference in the proportion of patients achieving a gain of ≥15 letters in best-corrected visual acuity (BCVA) at 11 months, comparing monthly ONS-5010 to quarterly LUCENTIS® (PIER regimen). While NORSE TWO has reported positive topline results consistent with prior bevacizumab data, the subsequent NORSE EIGHT trial, which evaluated 12-week data, did not meet its prespecified noninferiority endpoint at Week 8, although it did achieve noninferiority at Week 12 against ranibizumab. This mixed efficacy profile presents a significant hurdle for regulatory approval. Safety data from the NORSE program appears robust, aligning with historical safety profiles associated with bevacizumab. The most common adverse event reported is conjunctival hemorrhage, with no unexpected safety signals identified. A single case of iritis was noted (0.05% incidence), but no instances of retinal vasculitis were reported. The FDA has accepted the resubmitted Biologics License Application (BLA) as a Class 1 complete response, initiating the standard review period. Although ONS-5010 does not possess Fast Track, Orphan Drug, or Breakthrough Therapy designations for nAMD, it has been granted Priority Review status, suggesting that the FDA considers it potentially significant. The competitive landscape includes established anti-VEGF therapies such as LUCENTIS®, EYLEA®, and VABYSMO®. However, ONS-5010 differentiates itself through its cost-effectiveness and on-label status. Precedents such as the approval of bevacizumab gamma in the EU (LYTENAVA) lend support to the mechanism's validity, although the U.S. FDA maintains a more stringent approach regarding efficacy endpoints. The estimated Probability of Approval (PoA) stands at 65.0%, reflecting a strong safety profile, a clear market need, and the FDA's acceptance of the BLA, tempered by the uncertainties surrounding the CRL's request for "confirmatory evidence" and the NORSE EIGHT endpoint failure. Key risks include the possibility that the FDA may require a new trial, which could delay commercialization, as well as the rare but notable safety signal related to inflammation. The upcoming FDA decision on December 31, 2025, represents a critical catalyst; a favorable outcome could position Outlook as a commercial entity with a 12-year marketing exclusivity period for the first FDA-approved ophthalmic bevacizumab. Investors should remain vigilant for any FDA communications that clarify the nature of the required evidence prior to the decision date. Read More | ±35.7% | 10.52 M | – | CRITICAL | 7.75 | 4.68 | 20.16 M | 7.4% | |||
 VTRSViatris Inc. | 17.8 0.96% | +7.0% | 19.39 B | PDUFA Date 2026-07-30 | MR-100A-01 (investigational low-dose estrogen CHC weekly patch) Contraception; women of childbearing potential | PDUFA | 92.5% MR-100A-01, developed by Viatris (VTRS), is an investigational once-weekly transdermal contraceptive patch that delivers low-dose norelgestromin (4.86 mg) and ethinyl estradiol (0.264 mg), which is equivalent to approximately 150/35 mcg per day. This combined hormonal contraceptive (CHC) is specifically designed for women of childbearing potential with a body mass index (BMI) of less than 30 kg/m² who are seeking a non-invasive, reversible contraceptive option with reduced estrogen exposure compared to existing patches, such as Xulane® (Viatris' own 150/35 mcg/day product). As a lifecycle advancement of Xulane, MR-100A-01 leverages Viatris' expertise in transdermal technology to potentially offer best-in-class adhesion and consistent hormone delivery. The global contraception market is projected to exceed $22 billion by 2025, driven by the demand for oral pills, long-acting reversibles (IUDs and implants), and patches. However, the market currently lacks significant unmet needs, as established therapies demonstrate over 99% efficacy with perfect use. MR-100A-01 aims to position itself as a best-in-class option within the CHC patch category, differentiating itself through lower estrogen levels, which may reduce side effects such as nausea and breast tenderness, as well as superior adhesion demonstrated under extreme conditions like heat and sweat, without introducing novel mechanisms. The development of MR-100A-01 has reached a late-stage success, evidenced by the pivotal Phase 3 multicenter, open-label, single-arm trial (NCT05139121), which enrolled 1,319 healthy post-menarcheal women aged 16 years and older who were at risk of pregnancy. Over the course of 13 cycles (12 months), the trial met its primary endpoint of contraceptive efficacy, as measured by the Pearl Index (PI), which indicates pregnancies per 100 women-years, showing favorable rates, although the exact PI has not been publicly detailed. Secondary endpoints included cycle control, safety, and tolerability, with results indicating strong adhesion and pharmacokinetics. Safety outcomes aligned with those typically seen in CHCs, with no new safety signals identified; exclusions included depression and drug abuse, but marijuana use was permitted at the discretion of investigators. Enrollment for the trial has been completed, and it is no longer recruiting participants. Currently, no regulatory designations apply to MR-100A-01, as it has not received Fast Track, Orphan, Breakthrough, Priority Review, or Accelerated Approval status for this indication. The New Drug Application (NDA), filed under the 505(b)(2) pathway referencing data from Xulane, has been accepted, with a Prescription Drug User Fee Act (PDUFA) target action date set for July 30, 2026. Positive topline data are expected to be presented at the ACOG 2026 conference, highlighting efficacy and safety. In terms of competitive positioning, MR-100A-01 offers improvements over existing products like Xulane and Twirla, which have higher estrogen levels and adhesion issues, as well as non-patch options that impose daily compliance burdens. The pipeline does not currently present direct threats from other low-dose weekly patches; however, the progestin-only patch MR-130A-01 (NCT06672016) targets estrogen-intolerant women but is still in earlier stages of development. The estimated probability of approval (PoA) for MR-100A-01 stands at 92.5%. This figure reflects the standard success rates for the 505(b)(2) pathway, which are approximately 90% for contraceptives following NDA acceptance with positive Phase 3 data. The robust single-arm data mirrors that of approved patches, and Viatris has a strong track record, including the successful approval of Xulane and a lack of recent NDA rejections in women's health. Key risks include potential FDA scrutiny regarding adhesion performance and pharmacokinetics under real-world conditions, as well as safety signals related to low-dose estrogen in the BMI <30 subgroup. Despite these risks, Viatris stands to benefit from relatively low research and development risk, with potential peak sales estimated between $200 million and $500 million due to product differentiation. Upcoming catalysts hinge on the PDUFA date, with approval potentially driving a 10-20% increase in stock value. Read More | ±9.4% | -2.51 M | – | PROFITABLE | 1.81 K | 180.72 M | 2.83 M | 4.11% | ||
 ARWRArrowhead Pharmaceuticals, Inc. | 83.83 -2.08% | +14.8% | 9.98 B | Phase 1/2a data readout 2026-07 | ARO-ALK7 Adult obesity (single-ascending dose and multiple-ascending dose; monotherapy with potential later combination cohorts) | Phase 1/2a | — | ±12.9% | -456.63 K | 7 +3% | CRITICAL | 188.52 | 47.09 | 606.76 K | 7.27% | ||
 RGNXREGENXBIO Inc. | 9.5 -2.16% | +45.8% | 328.28 M | Phase 1/IIa data readout 2026-07 | Phase 1 | 22.5% Surabgene lomparvovec (sura-vec, ABBV-RGX-314), developed by REGENXBIO in collaboration with AbbVie, is a first-in-class, one-time investigational gene therapy aimed at treating wet age-related macular degeneration (AMD). This innovative therapy employs the NAV® AAV8 vector to encode an antibody fragment that inhibits vascular endothelial growth factor (VEGF), with the goal of providing sustained suppression of leaky blood vessel growth and fluid accumulation in the retina, thereby eliminating the need for repeated injections. The global market for wet AMD is substantial, estimated at $15 billion, driven by a significant unmet medical need. Patients currently face the burden of frequent intravitreal anti-VEGF injections, typically required on a monthly or quarterly basis, which can lead to treatment fatigue and potential vision loss due to non-adherence. Surabgene lomparvovec addresses this challenge by offering a potential one-time treatment, which could reduce the injection burden by 92% (from an average of 8.8 to 0.7 annually) and achieve 60% injection-free status in second eyes at one year. Currently, sura-vec is in Phase 3 development for wet AMD, with the pivotal randomized controlled ACHIEVE trial, sponsored by AbbVie, having completed enrollment in October 2025. This trial is designed to compare sura-vec delivered via subretinal injection against the standard-of-care treatment, ranibizumab, focusing on the reduction of injection burden and the preservation of long-term vision. Earlier Phase I/IIa data indicated promising safety and efficacy, with 60 participants demonstrating stable or improved vision after one year and no serious adverse events reported. A bilateral study presented at EURETINA 2025 further corroborated these findings, showing safety and efficacy in both eyes, along with a significant 92% reduction in injection frequency. Despite these encouraging results, it is noteworthy that no formal FDA regulatory designations—such as Fast Track, Breakthrough, or Orphan Drug—have been granted specifically for wet AMD. The competitive landscape for wet AMD treatment includes several approved anti-VEGF agents, such as aflibercept and ranibizumab, alongside emerging gene therapies. However, sura-vec stands out as the first gene therapy to demonstrate bilateral efficacy and significant reduction in injection frequency. Precedents in the field, including RGX-202 for Duchenne muscular dystrophy and other AAV gene therapies, highlight the importance of safety, particularly concerning intraocular inflammation, and the long-term durability of treatment effects as critical factors influencing FDA decisions. The estimated Probability of Approval (PoA) for sura-vec is 22.5%, reflecting both the high potential for clinical benefit and the considerable risks involved, including intraocular safety signals, variability in surgical delivery methods, and uncertainty regarding the long-term durability of treatment effects. Looking ahead, key upcoming catalysts include the presentation of 5-year long-term follow-up data from the Phase I/IIa trial at the ASRS conference, expected in 2026, and the eventual data readout from the ACHIEVE trial, although specific timing for this has not been disclosed. Investors should remain vigilant regarding intraocular safety data and long-term durability outcomes, as these will be critical determinants for FDA approval and the overall success of surabgene lomparvovec in the market. Read More | ±19.6% | -3.21 M | 4 +9% | DISTRESSED | 150.49 | 25.39 | 446.03 K | 22.31% | |||
RGNXREGENXBIO Inc. | 9.5 -2.16% | +45.8% | 328.28 M | Phase 2 data readout 2026-07 | Phase 2 | 22.5% Surabgene lomparvovec (sura-vec, ABBV-RGX-314), developed by REGENXBIO (Nasdaq: RGNX) in collaboration with AbbVie, represents a first-in-class one-time gene therapy aimed at delivering sustained anti-VEGF activity for diabetic retinopathy (DR). This innovative therapy employs the NAV® AAV8 vector to encode an antibody fragment that inhibits vascular endothelial growth factor (VEGF), the primary driver of fluid accumulation and neovascularization in the retina. DR is the leading cause of vision loss among adults aged 24 to 75, impacting nearly 10 million individuals in the United States alone, with a global market size estimated at $12.5 billion. Current treatment options are limited to "watchful waiting" for non-proliferative DR (NPDR) or frequent anti-VEGF injections, highlighting a significant unmet need for a durable, one-time therapeutic solution. The sura-vec program is currently in Phase IIb/III, with the pivotal NAAVIGATE trial (NCT07592273) having commenced in June 2026. This multicenter, randomized, masked, sham-controlled study is set to enroll 576 patients diagnosed with NPDR without center-involved diabetic macular edema. The primary endpoint focuses on achieving a greater than two-step improvement on the Diabetic Retinopathy Severity Scale (DRSS) within one year. Prior data from the Phase II ALTITUDE trial (NCT04567550) indicated that sura-vec was well tolerated at dose levels 1 to 3, with no drug-related serious adverse events reported as of June 2025 and no intraocular inflammation observed at the highest dose (1.0×10¹² GC/eye) over a two-year period. While these findings are encouraging, gene therapies inherently carry risks of inflammation and long-term vector-related adverse events, which remain critical considerations. Currently, sura-vec lacks any regulatory designations specific to diabetic retinopathy; it has not received Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval for this indication. The competitive landscape is evolving, with emerging oral kallikrein inhibitors (such as RZ402) and topical agents (like OPL-0401) presenting potential lower-risk alternatives if they demonstrate comparable efficacy. Historical precedents, including RGX-202 for Duchenne muscular dystrophy and other AAV-based retinal therapies, have shown that safety profiles and delivery methods significantly influence FDA decision-making. The estimated Probability of Approval (PoA) for sura-vec stands at 22.5%, indicating a moderate chance of success that is contingent upon the robustness of primary endpoint data from the NAAVIGATE trial and ongoing safety confirmations. Key risks associated with this therapy include potential gene therapy-specific adverse events, the complexity of delivery via suprachoroidal injection, and competitive pressures from emerging therapies that could erode market share. Upcoming catalysts include the anticipated data on the primary endpoint from the NAAVIGATE trial, as well as extended follow-up results from the ALTITUDE trial, although specific timing for these updates has yet to be disclosed. Investors are advised to closely monitor safety signals and the progress of clinical trials, as the success of sura-vec will depend on demonstrating both efficacy and long-term tolerability within a high-stakes chronic disease context. Read More | ±19.6% | -3.21 M | 4 +9% | DISTRESSED | 150.49 | 25.39 | 446.03 K | 22.31% |
• FAQs
Frequently asked questions about the FDA calendar
A PDUFA date is the deadline by which the FDA aims to complete its review of a new drug or biologic application and issue a decision. The name comes from the Prescription Drug User Fee Act, the law that lets the FDA collect fees from drug makers in exchange for committing to these review timelines. On or before the PDUFA date the FDA will approve the drug, issue a Complete Response Letter, or otherwise act on the application. Because these dates are binary events, they are among the most watched catalysts for biotech stocks, and upcoming ones are listed on the calendar above.
The calendar above can be sorted by date so you can see decisions expected in the current week or over the next five trading days, including small-cap biotech catalysts. Recently issued approvals and Complete Response Letters are listed alongside upcoming dates, so you can review both what just happened and what is coming next. Because the FDA can act a few days before a listed PDUFA date, it is worth watching the days leading up to each event, not just the date itself.
No. The FDA does not publish a public, forward-looking calendar of pending PDUFA dates, because confidentiality rules (21 CFR 314.430) generally bar it from confirming that an application even exists until the sponsor makes it public. The PDUFA dates you see in calendars come from the drug companies themselves, who disclose expected action dates in press releases and SEC filings, and from aggregators that compile and verify them. The calendar on this page is one such aggregated, regularly updated source.
A Complete Response Letter is the FDA's way of telling a drug company that its application cannot be approved in its current form. The letter spells out the deficiencies the company must address, which can range from manufacturing and labeling issues to questions about safety or effectiveness. A CRL is not a permanent rejection: the sponsor can fix the problems and resubmit, which starts a new review cycle and a new PDUFA date. CRLs often trigger sharp stock declines because they delay or jeopardize a product launch.
An Advisory Committee, or AdCom, is a panel of outside experts the FDA convenes to review a drug's data and vote on questions about its safety and efficacy. The vote is non-binding, but the FDA usually follows the panel's recommendation, so the outcome is a major catalyst. AdComs typically take place several months before the PDUFA date and can move a stock sharply in either direction on the day of the vote. Scheduled AdCom dates appear alongside PDUFA dates on the calendar above.
A New Drug Application (NDA) is the submission used to seek approval for small-molecule, chemically synthesized drugs, while a Biologics License Application (BLA) covers biologics such as antibodies, vaccines, and cell and gene therapies. Both are reviewed under the same PDUFA timelines and both result in either approval or a Complete Response Letter. The distinction matters because biologics follow a separate regulatory pathway and have different exclusivity rules.
After Phase 3 trials finish, a company typically needs 6 to 12 months to compile and submit the New Drug Application (NDA) or Biologics License Application (BLA). The FDA then takes about 60 days to decide whether to accept the filing, after which the formal review clock runs 10 months for a standard review or 6 months for a priority review. In total, the path from Phase 3 completion to an FDA decision often spans roughly a year and a half to two years, though it varies widely by program and review type. Each application's specific PDUFA decision date appears on the calendar above once it is set.