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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 Oct 12, 2026
Showing 11 Catalysts Out Of 1235. 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 OCULOcular Therapeutix, Inc. | 7.54 0.40% | -27.2% | 1.66 B | Phase 3 data presentation 2026-10-12 | Phase 3 | 68% OTX-TKI, branded as Axpaxli, is Ocular Therapeutix’s innovative intravitreal axitinib hydrogel implant targeting neovascular age-related macular degeneration (nAMD). As of October 1, 2026, the program is in Phase 3, with the SOL-1 trial identified as NCT06223958 and SOL-R as NCT06495918. The SOL-1 trial is a multicenter, double-masked, randomized, parallel-group Phase 3 study focusing on treatment-naïve nAMD patients. Its primary endpoint is to maintain vision, defined as a loss of fewer than 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters by Week 36. Reports indicate that SOL-1 successfully met its primary endpoint, with 74.1% of patients maintaining vision with OTX-TKI compared to 55.8% with aflibercept at Week 36, achieving a statistically significant result (p = 0.0006). This trial is particularly noteworthy as it was designed as a head-to-head superiority study under a special protocol assessment. The SOL-R trial is a registrational Phase 3, double-masked, randomized study involving 555 patients, who are randomized in a 2:2:1 design to compare AXPAXLI dosed every six months against aflibercept administered every eight weeks. Additionally, a Phase 3b extension study (NCT07516132) has been disclosed for long-term safety follow-up. Despite the promising results from SOL-1, published efficacy details beyond the top-line signal remain limited. It is important to note that overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) are not applicable endpoints for this ophthalmology program. Safety appears broadly manageable based on public summaries, with no major new class-wide signals reported. However, the key approval risks include the durability of the treatment, potential procedure-related complications inherent to intravitreal implants, and the confirmation of a favorable benefit-risk balance over longer follow-up periods. In terms of regulatory designations, OTX-TKI has not received Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval status, which may limit regulatory flexibility but does not preclude the possibility of approval. The estimated probability of approval (PoA) for OTX-TKI stands at 68.0%. The market opportunity for nAMD is substantial, with a global market size estimated at approximately $13-15 billion. This is driven by the chronic use of anti-VEGF therapies and the persistent treatment burden faced by patients. The unmet need in this space remains significant, as many patients continue to require frequent injections, and challenges with real-world adherence and treatment durability persist. OTX-TKI is positioned as best-in-class, distinguishing itself from first-in-class or me-too products. While the target biology is not novel, the sustained-release hydrogel implant and six-month dosing schedule represent a significant differentiation from standard anti-VEGF injection regimens. In the competitive landscape, established products include aflibercept, ranibizumab, faricimab, and brolucizumab, along with newer durability-focused approaches. The commercial advantage of OTX-TKI will depend on its ability to demonstrate durable vision maintenance with an acceptable safety profile and a convenient dosing regimen. Ocular Therapeutix has no history of FDA rejections relevant to this program, and the value of its key partnership lies in the internally developed Axpaxli platform rather than a major external pharmaceutical alliance. Historical precedents in nAMD suggest that FDA success typically requires robust visual outcomes, clinically meaningful durability, and a favorable safety profile. The sector has also shown that long-acting delivery systems can fail if inflammation or procedural risks undermine the convenience benefits. Overall, while the program appears more likely than not to succeed given its positive Phase 3 signal and the validation of the indication, approval is not guaranteed until replication of results, long-term safety, and comprehensive registrational evidence are established. Read More | ±9.9% | -480.14 K | 9 -2% | HEALTHY | 598.64 M | 22.42 M | 2.63 M | 14.91% | |||
 CYTKCytokinetics, Incorporated | 62.91 1.45% | -12.7% | 7.83 B | Phase 3 data presentation 2026-10-12 | Phase 3 | 88% The current evidence indicates a high probability of approval for aficamten in nonobstructive hypertrophic cardiomyopathy (nHCM), with an estimated probability of approval (PoA) at 88.0%. This assessment is primarily based on the successful outcomes of the pivotal Phase 3 ACACIA-HCM trial, which met both primary endpoints using a robust randomized placebo-controlled dataset. Importantly, no new major safety signals were identified beyond the expected class effect of left ventricular ejection fraction (LVEF) reduction. However, residual risks remain, including potential FDA scrutiny regarding systolic dysfunction, labeling and monitoring requirements, and the necessity for a comprehensive regulatory package rather than relying solely on topline results for approval. In terms of regulatory designations for nHCM, the following statuses are noted: ```json { "FastTrackDesignation": false, "OrphanDrugDesignation": false, "BreakthroughTherapyDesignation": false, "PriorityReview": false, "AcceleratedApproval": false } ``` The market analysis reveals a multi-billion dollar global market for nHCM, although specific estimates for the nHCM-only segment are not consistently available in public sources. There is a significant unmet need in this area, as symptomatic nHCM currently lacks disease-specific therapies, and there is no established myosin-inhibitor standard comparable to that for obstructive HCM. This gap underscores the necessity for improved symptom management and enhanced functional capacity. Aficamten is classified as best-in-class within its category. Key risks associated with aficamten include the potential for LVEF suppression and heart failure due to cardiac myosin inhibition, which could necessitate dose interruptions, lead to boxed warnings, or result in restrictive labeling. Additionally, the FDA may require more comprehensive durability and safety follow-up prior to approval if the agency perceives the efficacy gains as modest or the safety monitoring as overly burdensome. Furthermore, the competitive landscape and labeling complexities in relation to approved myosin inhibitors for obstructive HCM could limit the commercial potential of aficamten, even if approval for nHCM is achieved. Looking ahead, several upcoming catalysts could impact the investment landscape. These include the FDA's decision on the nHCM filing, the timing of which has not been disclosed, as well as the detailed presentation and publication of the full ACACIA-HCM results. Updates regarding potential label-expansion strategies from Cytokinetics are also anticipated, although specific timelines remain unspecified. Aficamten (MYQORZO) is Cytokinetics’ oral cardiac myosin inhibitor for hypertrophic cardiomyopathy, already established in obstructive HCM and now supported by pivotal Phase 3 data in symptomatic nHCM. The nHCM program is centered around the ACACIA-HCM trial, a multicenter, randomized, double-blind, placebo-controlled Phase 3 study (NCT06081894) that enrolled 516 participants outside Japan, comparing aficamten against placebo on a 1:1 basis. The study's design included dual primary endpoints assessing changes from baseline to Week 36 in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) and peak VO2, with key secondary endpoints focusing on additional functional and biomarker measures. Cytokinetics reported that ACACIA-HCM met both primary endpoints with statistically significant improvements compared to placebo, and secondary endpoints also favored aficamten. While topline summaries suggest meaningful benefits in symptoms and exercise capacity, detailed hazard ratios and confidence intervals have yet to be fully disclosed. Safety remains a critical focus, as aficamten's mechanism can lead to reductions in left ventricular systolic function, with reported instances of LVEF decline below 50% in treated patients, consistent with expected pharmacology. Although this risk has not resulted in a novel or prohibitive toxicity signal, it is likely to influence conservative labeling and monitoring requirements. Overall, the nHCM program appears substantially de-risked by positive Phase 3 efficacy results; however, the probability of approval is tempered by uncertainties surrounding safety labeling and the potential for regulators to seek additional data before broadening the indication. Read More | ±6.8% | -14.29 M | 13 -22% | HEALTHY | 1.70 B | 53.28 M | 1.12 M | 13.03% | |||
 EWTXEdgewise Therapeutics, Inc. | 39.06 -0.43% | -8.7% | 4.24 B | Phase 1 data presentation 2026-10-12 | Phase 1 | 14% EDG-15400 is a novel oral, selective cardiac sarcomere modulator developed by Edgewise Therapeutics for the treatment of heart failure, with a primary focus on heart failure with preserved ejection fraction (HFpEF). The current clinical study is a Phase 1, randomized, double-blind, placebo-controlled trial involving healthy adults, identified by the clinical trial number NCT07177066. This trial evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of EDG-15400, with participants receiving either the drug or a placebo. The study is designed for healthy adults aged 18 to 59, with a planned enrollment of 108 participants. As of August 2026, Edgewise reported that dosing has been completed, indicating that the Phase 1 portion is likely in the data-readout or analysis stage. It is important to note that no efficacy endpoints such as overall response rate (ORR), progression-free survival (PFS), or overall survival (OS) are applicable to this study, and no efficacy results have been published to date. From a commercial perspective, the market for "healthy adult participants" is effectively non-existent, resulting in a direct market size of $0. The actual investment opportunity lies in the future HFpEF market, which presents a significant unmet need due to the limitations of current therapies and the fact that many patients remain symptomatic despite available treatments. EDG-15400 is positioned as a first-in-class asset, as it represents a novel selective cardiac sarcomere modulator, with no existing approved therapies sharing this exact mechanism for HFpEF. However, the absence of human proof-of-concept data places the program in a high-risk category rather than a de-risked best-in-class profile. Regulatory designations for healthy adults are absent, with no Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval designations applicable to this Phase 1 safety study. These pathways are typically associated with disease treatment programs and future new drug application (NDA) or biologics license application (BLA) submissions, not with studies involving healthy volunteers. There is no public information indicating any regulatory designation for EDG-15400 in this context. In terms of competitive landscape, EDG-15400 will need to differentiate itself from other HFpEF programs and broader cardiac contractility modulators. Its success will depend on the ability to improve filling pressures, alleviate symptoms, enhance exercise capacity, and reduce hospitalizations without incurring unacceptable safety risks. Historical precedents indicate that the FDA favors clear efficacy demonstrated alongside a strong safety profile; however, cardiac programs can fail if they exhibit unfavorable hemodynamic effects or tolerability issues. For instance, HFpEF and cardiovascular drugs often encounter challenges when biomarker improvements do not translate into tangible patient benefits, while successful approvals in related cardiovascular areas have necessitated robust event reduction or compelling symptomatic improvements. The estimated probability of approval (PoA) for EDG-15400 stands at 14.0%. This figure reflects the early Phase 1 status of the asset, which currently lacks clinical efficacy evidence, does not possess any special regulatory designations, and faces significant safety uncertainties related to its mechanism of action. The PoA is primarily supported by the sponsor's advancement into human testing rather than any established proof of efficacy. Key risks include first-in-human safety concerns, the translational uncertainty from healthy volunteers to HFpEF patients, and execution risks associated with later-stage development. Upcoming catalysts include the anticipated initiation of the Phase 2 trial in HFpEF, expected in the second half of 2026, as well as the subsequent disclosure of data from both the healthy volunteer study and the HFpEF trial. Read More | ±7.6% | -1.90 M | 12 -2% | HEALTHY | 460.71 M | 14.16 M | 1.06 M | 11.65% | |||
 EPRXEupraxia Pharmaceuticals Inc. | 7.46 -1.45% | +11.8% | 485.04 M | Phase 1b/2 data presentation 2026-10-12 | Phase 1b/2 | 22% EP-104GI is Eupraxia Pharmaceuticals’ long-acting fluticasone propionate intra-esophageal injection designed for the treatment of eosinophilic esophagitis (EoE). This innovative approach aims to provide localized corticosteroid exposure directly within the esophagus while minimizing systemic effects. The drug is classified as first-in-class, and its lead clinical study, RESOLVE (NCT05608681), is currently in the Phase 1b/2 stage. Initially described as a multicenter open-label dose-escalation trial, the study has evolved to include an expanded randomized Phase 2b design. However, it is important to note that the program has not yet reached a registrational stage. The RESOLVE study is focused on evaluating the safety, tolerability, feasibility, pharmacokinetics, and efficacy of EP-104GI in adults with active, histologically confirmed EoE. According to publicly available updates, the trial is actively recruiting approximately 117 patients, with an estimated completion date of December 1, 2026. The study design reportedly incorporates a placebo/vehicle control in its later stages, with endpoints that assess endoscopic and histologic disease activity, symptom outcomes, and safety. Preliminary efficacy data have highlighted histologic improvements, particularly in the 8 mg dose cohort, which has shown significant reductions in eosinophil counts and other tissue measures. However, comprehensive peer-reviewed efficacy statistics, including p-values and confidence intervals, have yet to be published. It is also important to note that traditional oncology endpoints such as overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) are not applicable in the context of EoE. Safety data thus far appears promising, with reports indicating no serious adverse events or cases of candidiasis in the higher-dose cohort. Nonetheless, the small sample sizes and the inherent biases of open-label studies raise concerns about the durability and reproducibility of the results. Furthermore, the absence of any FDA Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval designations for EP-104GI is notable. In terms of market dynamics, the global market for EoE is projected to reach approximately $0.9 billion by 2025, with a recognized unmet need due to the limitations of existing therapies. Current treatment options, including swallowed topical steroids and biologic therapies, do not adequately address all aspects of symptom relief, inflammation, and fibrotic disease. EP-104GI stands out as a first-in-class option, distinguishing itself from existing therapies with its unique intra-esophageal extended-release delivery method. The approval of dupilumab has set a precedent, demonstrating that strong symptom and histologic data can facilitate EoE drug approvals. However, other EoE drug candidates have struggled to translate histologic improvements into meaningful symptom relief, which poses a challenge for EP-104GI. Eupraxia Pharmaceuticals is a development-stage company with a limited track record of FDA approvals, which may impact investor confidence compared to larger, established sponsors. The overall probability of approval (PoA) for EP-104GI is estimated at 22.0%. This figure reflects the drug's innovative mechanism and early promising histologic signals, tempered by the challenges associated with its early-stage development, the lack of pivotal evidence, small datasets, and the competitive landscape in EoE, where the FDA is likely to demand robust evidence of symptom and tissue benefits from well-controlled trials. Read More | – | - | 8 +11% | — | 80.42 M | 2.71 M | 1.05 M | 14.17% | |||
T TRAXFirst Tracks Biotherapeutics, Inc. | 31.85 -0.50% | -23.9% | 1.14 B | Phase 1b topline data readout 2026-10-12 | Phase 1b | 8% ANB033 is an investigational monoclonal antibody being developed by AnaptysBio, Inc. under the ticker TRAX, targeting celiac disease, an autoimmune disorder triggered by gluten exposure. This drug functions as a CD122 antagonist, which targets the common beta subunit of the IL-2 and IL-15 receptors. By inhibiting this pathway, ANB033 aims to diminish the pathogenic natural killer cells and certain subsets of cytotoxic CD8+ and CD4+ T cells that rely on IL-2 or IL-15 for their persistence and activity. This mechanism is distinct from dietary and enzymatic approaches, positioning ANB033 as a first-in-class therapy for celiac disease, with the potential to be classified as best-in-class within the CD122 antagonism category. The global market for celiac disease treatment is projected to reach approximately $690.2 million in 2024, with expectations of growing to $1.34 billion by 2030. This commercial opportunity may exceed current treatment market revenues, as the majority of patients do not receive any disease-modifying drug therapies. The unmet need in this space is substantial; a strict gluten-free diet remains the only established treatment, and adherence to this regimen is challenging. Accidental gluten exposure is frequent, and intestinal inflammation or villous injury can persist despite dietary management. AnaptysBio has indicated that celiac disease affects over 2.1 million individuals in the United States, with no approved therapies currently available. Currently, ANB033 is in Phase 1b development. The ongoing study is a multicenter, randomized, double-blind, placebo-controlled trial involving approximately 60 participants, who are randomized 1:1 to receive either subcutaneous ANB033 or a placebo. Cohort 1 consists of around 30 patients with less-damaged mucosa, who will receive treatment for four weeks followed by a daily gluten challenge for 14 days, with biopsy assessments at Week 6 to evaluate the prevention of gluten-induced mucosal damage. Cohort 2 includes approximately 30 patients with more significant mucosal injury, treated for four weeks and assessed by biopsy at Week 12 for potential mucosal healing. The primary objectives of the trial are to evaluate safety and tolerability, while pharmacokinetic and pharmacodynamic assessments, along with exploratory outcomes related to gastrointestinal symptoms and intestinal histology, are also included. As of now, no patient-level efficacy results, objective response rates, or other detailed clinical data have been publicly reported. Although Phase 1a results in healthy volunteers have been described as favorable regarding safety and tolerability, specifics concerning adverse event frequencies, discontinuations, and exposure duration remain undisclosed. The principal upcoming catalyst for ANB033 is the top-line Phase 1b data expected in Q4 2026. Regarding regulatory designations, ANB033 does not currently hold any celiac-specific Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval designations. The competitive landscape includes immune modulators, gluten-degrading enzymes, barrier-protective agents, and antigen-specific approaches. However, the absence of an approved pharmacologic comparator provides a unique positioning opportunity. There are limited precedents in the celiac disease space, as no recently approved drugs have established a validated approval pathway. Immune-directed therapies in other autoimmune conditions highlight both the potential and risks associated with infection, immunosuppression, and the necessity for durable clinical benefits. The estimated probability of approval (PoA) for ANB033 stands at 8.0%. This figure reflects a standard early Phase 1b base rate, adjusted for the lack of efficacy data, small sample size, uncertain correlation between histological improvement and clinical benefit, and potential long-term immune safety concerns. A robust Phase 1b outcome demonstrating significant protection against gluten-induced injury, evidence of mucosal healing, acceptable immune safety, and a clear dose-response relationship could substantially increase the PoA estimate. Conversely, a negative histological result or significant immunologic toxicity could sharply diminish it. Read More | ±58.4% | -1.98 M | – | STABLE | 168.02 M | 10.64 M | 855.24 K | 14.82% | |||
T TECXTectonic Therapeutic, Inc. Common Stock | 23.33 2.55% | -34.5% | 456.09 M | Phase 1a data presentation 2026-10-12 | Phase 1a | 18% TX2100 is a VHH-Fc fusion antagonist antibody developed by Tectonic Therapeutics, specifically targeting the APJ/apelin receptor pathway, which is a pro-angiogenic GPCR axis implicated in hereditary hemorrhagic telangiectasia (HHT). The company positions TX2100 as a potential first-in-class therapy for HHT, a condition currently lacking approved disease-modifying treatments. The market for HHT is estimated to be between $0.3 billion and $0.6 billion globally, with a significant unmet need due to the absence of effective therapies. Care for HHT patients is primarily supportive and symptom-directed, focusing on recurrent epistaxis, iron-deficiency anemia, transfusion dependence, and complications related to arteriovenous malformations (AVMs). As of late September 2026, TX2100 is still in the early stages of development, currently undergoing a Phase 1a trial involving healthy volunteers that commenced in February 2026. This trial is designed as a randomized, placebo-controlled, double-blind, ascending-dose study, with safety and tolerability as the primary endpoints and pharmacokinetics as a secondary endpoint. While several single-dose cohorts have been administered, no efficacy data in HHT patients have been released, and metrics such as overall response rate (ORR), progression-free survival (PFS), overall survival (OS), hazard ratios, and other response-related efficacy measures are not applicable at this stage. The upcoming catalysts for TX2100 include topline results from the Phase 1a trial, expected by the end of Q4 2026, although initial expectations were set for the end of Q3 2026. Additionally, Tectonic plans to initiate a Phase 1b trial in hematologic-support-dependent HHT patients, as well as a placebo-controlled Phase 2 trial in moderate-to-severe HHT patients, although specific timelines for these studies have not been disclosed. The regulatory landscape for TX2100 currently shows no Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval designations, indicating a conservative assessment of its regulatory prospects. The competitive landscape for HHT is relatively sparse, with no approved disease-modifying therapies available. Current treatment options primarily involve supportive care, ablative procedures, and investigational agents aimed at addressing bleeding or vascular dysregulation. This lack of approved competition may provide a commercial advantage for TX2100, but it also means that FDA precedents are limited, necessitating compelling clinical endpoints. Key risks associated with TX2100 include its current status in Phase 1a testing, which means there is no human efficacy evidence available for HHT at this time. The mechanism of action, while novel, has not been clinically validated in the context of HHT, and the program's success hinges on demonstrating safety, tolerability, and meaningful clinical benefits in later-phase trials. The absence of established FDA approvals for Tectonic increases execution risk compared to more seasoned biotechs. In summary, TX2100 presents an attractive first-in-class opportunity within a significant unmet need; however, it remains in the pre-proof-of-concept stage. Given these factors, the estimated probability of approval stands at 18.0%, reflecting the challenges and uncertainties inherent in early-stage biotech development. Read More | ±19.8% | -16.69 K | 7 -1% | HEALTHY | 227.07 M | 7.15 M | 110.71 K | 21.81% | |||
 ALECAlector, Inc. | 2.08 2.97% | -11.1% | 232.25 M | Pre-clinical data presentation 2026-10-13 | Pre-clinical | ±9.1% | -578.01 K | 5 +18% | STABLE | 172.80 M | 11.41 M | 3.12 M | 7.41% | ||||
ALECAlector, Inc. | 2.08 2.97% | -11.1% | 232.25 M | Pre-clinical data presentation 2026-10-13 | Pre-clinical | ±9.1% | -578.01 K | 5 +18% | STABLE | 172.80 M | 11.41 M | 3.12 M | 7.41% | ||||
ALECAlector, Inc. | 2.08 2.97% | -11.1% | 232.25 M | Pre-clinical data presentation 2026-10-13 | Pre-clinical | ±9.1% | -578.01 K | 5 +18% | STABLE | 172.80 M | 11.41 M | 3.12 M | 7.41% | ||||
 IRDOpus Genetics, Inc. | 4.65 4.26% | +26.0% | 384.31 M | Phase 1/2 data presentation 2026-10-14 | Phase 1/2 | ±16.1% | -4.32 M | – | STABLE | 88.81 M | 3.98 M | 1.26 M | 18.69% | ||||
 VSTMVerastem, Inc. | 8.38 3.33% | +16.1% | 758.92 M | Phase 1/2 data readout 2026-10-14 | Phase 1/2 | ±37.4% | -381.48 K | 6 +20% | CAUTION | 136.35 M | 14.64 M | 2.97 M | 22.05% |
• 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.