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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 Sep 11, 2026
Showing 6 Catalysts Out Of 1216. 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 TLXTelix Pharmaceuticals Limited | 11.305 -5.00% | +18.3% | 3.84 B | PDUFA Date 2026-09-11 | PDUFA | 64% Pixclara® (TLX101-Px; also known as floretyrosine F 18 / \(^{18}\)F-FET) is a PET imaging agent developed by Telix Pharmaceuticals, currently under review by the FDA through a New Drug Application (NDA) for the imaging of glioma, rather than brain metastases. The FDA has accepted the resubmitted NDA and assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 11, 2026. It is important to note that the available information does not indicate that this program is in any clinical phase beyond the NDA/PDUFA review stage, suggesting that it is at the regulatory decision point. The clinical rationale for Pixclara® is rooted in the significant unmet need within neuro-oncology imaging. Conventional MRI often struggles to differentiate between recurrent or progressive tumors and treatment-related changes, highlighting the necessity for improved imaging solutions. However, the evidence presented in the available sources is primarily focused on glioma characterization, not the diagnosis of brain metastases. Consequently, any assumptions regarding the commercialization of Pixclara® for brain metastases lack support from the current data. Based on the information provided, Pixclara® is classified as first-in-class for FET PET imaging, as it represents a novel radiotracer rather than a derivative of an existing PET agent. In terms of regulatory designations, the support for the glioma indication is favorable. The sources indicate that the FDA has acknowledged Fast Track and Orphan Drug designations, with one source also mentioning Priority Review for the NDA. However, it is crucial to emphasize that these designations pertain specifically to glioma imaging and not to brain metastases. There is no evidence in the provided materials to support Breakthrough Therapy or Accelerated Approval for the brain metastases indication, leading to those designations being marked as false or unknown. The analysis of key risks associated with Pixclara® reveals several challenges. Firstly, the publicly disclosed program is focused on glioma imaging, which raises concerns regarding the appropriateness of the requested indication for brain metastases. This mis-specification may result in a regulatory package that does not adequately support the use case for brain metastases. Additionally, the FDA has previously issued a non-approval decision, indicating that further clinical evidence was required, which underscores the importance of evidentiary adequacy for this program. As a PET imaging agent, the approval will hinge on demonstrating clinically meaningful diagnostic performance and reproducibility, which can be more demanding if the label claims are broad or if the evidence base is limited. The estimated probability of approval (PoA) for Pixclara® stands at 64.0%. This estimate reflects the late-stage nature of the product, which is currently under regulatory review and has received expedited designations. However, this probability is tempered by previous FDA concerns and the mismatch of indications. The key risks that could impact the approval process include the scope of the label, the adequacy of diagnostic performance evidence, and whether the resubmission successfully addresses prior FDA deficiencies. In summary, while Pixclara® presents a promising opportunity in the realm of neuro-oncology imaging, particularly for glioma, the challenges associated with its indication for brain metastases and the history of regulatory setbacks warrant careful consideration. Read More | – | - | – | — | 141.87 M | 1.44 M | 302.46 K | - | |||
TLXTelix Pharmaceuticals Limited | 11.305 -5.00% | +18.3% | 3.84 B | PDUFA Date 2026-09-11 | TLX101-Px (Pixclara®, Floretyrosine F18 / 18F-FET) Imaging of glioma, characterization of recurrent or progressive glioma from treatment-related changes in adult and pediatric patients Fast TrackOrphan | PDUFA | 78.5% TLX101-Px (Pixclara®) is a diagnostic positron emission tomography (PET) imaging agent developed by Telix Pharmaceuticals Limited (NASDAQ: TLX) for the characterization of recurrent or progressive glioma. This innovative agent aims to differentiate true tumor progression from treatment-related changes in both adult and pediatric patients. The drug addresses a significant clinical challenge: the ambiguity surrounding pseudoprogression—imaging changes that may be mistaken for genuine tumor progression—on conventional MRI, which can significantly impact treatment decisions. The global glioma PET imaging market is estimated to range from $500 million to $1.5 billion annually, although precise figures are not explicitly quantified in available sources. The unmet medical need in this space is substantial, as there are currently no FDA-approved targeted amino acid PET agents in the United States for glioma imaging. In Europe, 18F-FET PET imaging is only available under physician supervision at select hospital sites. The clinical implications of this diagnostic uncertainty are profound, as glioma patients often experience imaging changes that could represent either true progression necessitating therapy escalation or pseudoprogression that may resolve without intervention. This dilemma affects thousands of patients annually in developed healthcare systems. TLX101-Px is classified as a first-in-class agent, targeting L-type amino acid transporters 1 and 2 (LAT1 and LAT2). The mechanism of action involves the accumulation of 18F-FET (O-(2-[18F]fluoroethyl)-L-tyrosine) in metabolically active tumor tissue, allowing for enhanced visualization compared to standard gadolinium-enhanced MRI. The current standard of care relies on conventional MRI, which has limitations in differentiating between tumor progression and treatment effects. Currently, TLX101-Px is under FDA review, following the acceptance of a resubmitted New Drug Application (NDA) in May 2026. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of September 11, 2026. This resubmission came after a Complete Response Letter (CRL) issued in April 2025, where the FDA requested additional confirmatory evidence regarding diagnostic performance. The successful resubmission indicates that the new clinical data likely addressed the regulatory concerns raised previously. TLX101-Px has received both Fast Track designation (April 2024) and Orphan Drug designation (October 2020), highlighting the FDA's recognition of the significant unmet medical need and the potential clinical value of this agent. While specific trial names, NCT numbers, and detailed efficacy data are not disclosed, the acceptance of the resubmission suggests that the diagnostic performance data met regulatory standards. The clinical validation appears to align with established criteria for glioma imaging assessment. As a diagnostic imaging agent, TLX101-Px's approval will hinge on its diagnostic accuracy rather than traditional therapeutic efficacy endpoints, which typically presents a more straightforward regulatory pathway. In terms of competition, there are currently no FDA-approved agents for this specific indication in the United States. Internationally, clinical practice guidelines from the National Comprehensive Cancer Network (NCCN), European Association for Neuro-Oncology (EANO), and Response Assessment in Neuro-Oncology (RANO) endorse amino acid PET imaging, including 18F-FET, for glioma assessment. This existing guideline support significantly de-risks the approval process, as the FDA can reference established clinical practices. The estimated probability of approval for TLX101-Px stands at 78.5%. This figure reflects several positive factors, including the FDA's acceptance of the resubmitted NDA, the Fast Track and Orphan Drug designations, strong clinical guideline support, and the absence of direct competitors. However, some risks remain, such as limited public disclosure of specific diagnostic performance metrics and potential manufacturing challenges. Key upcoming catalysts include the FDA PDUFA decision on September 11, 2026, and the anticipated European MAA decision around November 2026. Additionally, interim data from the Phase 3 IPAX-BrIGHT trial of the companion therapeutic TLX101-Tx could further strengthen the case for TLX101-Px as a companion diagnostic. In conclusion, TLX101-Px represents a promising advancement in the diagnostic imaging landscape for glioma, addressing a critical unmet need and positioning itself favorably within the regulatory framework. Read More | – | - | – | — | 141.87 M | 1.44 M | 302.46 K | - | ||
 CVKDCadrenal Therapeutics, Inc. | 1.11 -5.93% | -43.5% | 3.96 M | Phase 2 data presentation 2026-09-11 | CAD-1005 Heparin-induced thrombocytopenia (HIT), Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) Fast TrackOrphan | Phase 2 | 28% CAD-1005 is an intravenous 12-lipoxygenase (12-LOX) inhibitor developed by Cadrenal Therapeutics for the treatment of heparin-induced thrombocytopenia (HIT) and, more recently, cardiac surgery-associated acute kidney injury (CSA-AKI). This program is positioned as a first-in-class anti-inflammatory and anti-thrombotic therapy, distinguishing itself from existing treatments, as no approved therapies share this mechanism for either HIT or CSA-AKI. Cadrenal has reported encouraging Phase 2 results for HIT, demonstrating an improved thrombotic event profile compared to placebo. The study was conducted as a blinded, placebo-controlled trial, with no serious adverse events attributed to the drug, no major bleeding signals, and no reported deaths. Treated patients exhibited over a 25% reduction in new or worsening thrombotic events versus placebo; however, detailed statistical metrics such as hazard ratios, confidence intervals, and p-values have not been disclosed. Following FDA feedback, the company has indicated that it is updating the primary endpoint for the registration study to focus on the worsening of HIT based on thromboembolic progression through Day 14 or hospital discharge. The development status of CAD-1005 has progressed beyond the initial "Phase 2" label. The HIT program has completed Phase 2 trials, received FDA Fast Track and Orphan Drug designations, and achieved orphan drug status from the European Medicines Agency (EMA). Cadrenal has also disclosed positive outcomes from an FDA Type D meeting regarding a Phase 3 registration study, which enhances the regulatory visibility of the program. In terms of CSA-AKI, the company has announced a Phase 2a clinical plan set for 2026, indicating that this indication is still in earlier stages compared to HIT. Market analysis reveals a combined long-term opportunity exceeding $1 billion globally, although no credible public sources specify a dedicated market figure for HIT or CSA-AKI. Both conditions currently lack approved disease-modifying therapies, with existing care primarily focused on supportive measures or the substitution of anticoagulants. The unmet need in this space is significant, reinforcing the potential for CAD-1005 as a first-in-class treatment. The competitive landscape for CAD-1005 is both favorable and challenging. Current treatment for HIT involves discontinuing heparin and utilizing alternative anticoagulants, with no targeted disease-modifying therapies available. Similarly, CSA-AKI represents a substantial unmet need, as prevention and treatment options remain largely supportive. The clinical heterogeneity of both indications and variable event rates contribute to heightened development risk. However, there are key risks associated with the program. While Phase 2 data are promising, they remain limited, and no Phase 3 efficacy or confirmatory safety data have been reported. The expansion of the program into CSA-AKI introduces additional execution risks and may dilute development focus. Furthermore, although the regulatory path has been partially de-risked through Fast Track and Orphan designations, the absence of Breakthrough or Accelerated Approval signals for this specific program remains a concern. Upcoming catalysts include the initiation of a Phase 3 registration study for HIT, details of which have not been disclosed, as well as additional late-breaking or full clinical readouts for the CSA-AKI Phase 2a plan. Potential business development or partnering updates for CAD-1005 are also anticipated, although specific timing remains undisclosed. In summary, the estimated probability of approval (PoA) for CAD-1005 stands at 28.0%. This figure is justified by the program's positive Phase 2 data, regulatory support, and a clear pathway toward Phase 3 trials. However, the lack of confirmatory pivotal data, broad safety exposure, and a fully mature regulatory package underscores the inherent risks associated with this investment opportunity. Read More | – | -270.81 K | – | CRITICAL | 2.39 | 0.74 | 118.86 K | 2.74% | ||
 ANIXAnixa Biosciences, Inc. | 2.7601 0.37% | -22.8% | 94.58 M | Phase 1 data presentation 2026-09-11 | Phase 1 | 18% Anixa Biosciences is advancing a first-in-class breast cancer vaccine designed as a preventive and therapeutic immunotherapy. This innovative approach utilizes alpha-lactalbumin, a protein associated with lactation, to train the immune system to recognize and target breast cancer cells while minimizing damage to normal tissues. The development of this vaccine is being conducted in collaboration with the Cleveland Clinic, with the investigational product currently undergoing Phase 1 trials, specifically under the clinical trial identifier NCT04674306. Recent updates indicate that the Phase 1 trial has completed patient visits, with 21 participants enrolled in one report and 35 in another. The trial has successfully met its primary safety and immunogenicity objectives, demonstrating that the vaccine is safe and well tolerated at the maximum tolerated dose. Notably, protocol-defined immune responses were observed in 74% of participants, with injection-site irritation being the most common adverse event reported. No significant safety signals or discontinuation issues have been highlighted in public disclosures. Despite these encouraging results, the program remains in the early stages of clinical development, with only Phase 1 data available and no validation of efficacy endpoints at this time. Anixa's plans for the next phase of development appear to be underway, as evidenced by a manufacturing agreement with Cytovance Biologics established in April 2026 for the supply of cGMP materials for the anticipated Phase 2 clinical trial. However, there is currently no publicly available information regarding the start date for Phase 2 trials, randomized outcomes, or any efficacy metrics such as overall response rate (ORR), progression-free survival (PFS), overall survival (OS), hazard ratios, or p-values. This lack of efficacy data limits confidence in the probability of approval, as the program has yet to demonstrate clinical efficacy in patients. From a regulatory standpoint, the vaccine has not received any specific designations for breast cancer, including Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval. The absence of these designations is significant, as they indicate a lack of late-stage efficacy evidence and highlight the challenges of navigating a broad indication like breast cancer, which typically does not meet orphan criteria. Nevertheless, the market opportunity remains substantial, with global breast cancer market estimates projected to reach $31.3 billion by 2025. The unmet need in this space is pronounced, particularly for high-risk, recurrent, and biologically aggressive subtypes of the disease. The competitive landscape for breast cancer treatments is notably crowded, featuring a variety of effective therapies including targeted agents, antibody-drug conjugates, endocrine therapies, PARP inhibitors, and immunotherapies. For the vaccine to succeed, it must not only demonstrate immunogenicity but also provide a clear clinical advantage, particularly in prevention or minimal-residual-disease settings. Historical precedents in cancer vaccines and immunotherapies suggest that robust immune activation alone is often insufficient for approval without accompanying clinical benefits. Given the early stage of development, the program's probability of approval is assessed at 18.0%. This estimate reflects the promising biological mechanism and an acceptable early safety profile, while also acknowledging the considerable clinical and regulatory uncertainties that remain. Read More | ±28.9% | 142.30 K | – | STABLE | 13.86 | 0.59 | 302.75 K | 3.09% | |||
 ENVBEnveric Biosciences, Inc. | 1.4231 -2.53% | +2.1% | 5.24 M | Pre-clinical data presentation 2026-09-11 | Pre-clinical | 12% EB-003 is Enveric Biosciences’ lead neuroplastogen and represents the company’s most advanced psychiatric program targeting antidepressant and anxiolytic effects. Described in public disclosures as a novel small-molecule, non-hallucinogenic serotonin receptor agonist, EB-003 is designed to engage both 5-HT2A and 5-HT1B receptors, exhibiting partial agonism at 5-HT2A and full agonism at 5-HT1B. Enveric positions this compound as a first-in-class therapy aimed at promoting neuroplasticity and emotional rebalancing while avoiding the hallucination liabilities associated with traditional psychedelics. While EB-003 is intended for depression, anxiety, and related neuropsychiatric conditions, this analysis specifically focuses on its antidepressant and anxiolytic effects. As of September 2, 2026, the program remains in the pre-clinical stage. Publicly disclosed data includes positive results from rodent studies in the Open Space Forced Swim Test, where oral administration of EB-003 at a dose of 30 mg/kg significantly reduced depression-like behavior within 30 minutes, achieving statistical significance with a p-value of less than 0.01, and demonstrating effects comparable to imipramine. Enveric has reported consistency in repeat studies, with no adverse locomotor effects observed at this dosage, as well as results from a 22-day daily dosing study that showed no adverse behavioral, physiological, or neurological effects. Additional disclosures indicate favorable oral bioavailability, effective brain penetration, and the completion of 7-day dose-range-finding toxicology studies in two preclinical species, which supports ongoing IND-enabling efforts. However, no clinical trial names, NCT numbers, randomized placebo-controlled human data, or human efficacy results are available, as the program has not yet entered human studies. Regulatory designations for the antidepressant and anxiolytic effects of EB-003 have not been publicly established. There are currently no Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval designations disclosed for this indication. Given that the program is still in preclinical development, there is no basis for FDA procedural designations at this time. From a market perspective, depression and anxiety represent substantial commercial opportunities, with a global market estimate for antidepressant and anxiolytic therapies around $18 billion. Despite this significant market potential, the opportunity is highly competitive and crowded. The unmet need remains pronounced, as many patients do not achieve durable remission with existing SSRIs, SNRIs, benzodiazepines, or newer adjunct therapies. Issues such as slow onset and tolerability continue to limit patient adherence. EB-003 is positioned as a first-in-class therapy, aiming to leverage a new neuropsychiatric mechanism rather than being a me-too SSRI or SNRI. However, being classified as first-in-class also introduces higher development risk due to the lack of clinical validation for its mechanism. The competitive landscape includes approved fast-acting or novel psychiatric agents like esketamine, which underscores the interest in rapid-onset antidepressant approaches, as well as pipeline compounds inspired by psychedelics that aim for durable symptom relief with improved outpatient usability. Recent precedents indicate that FDA scrutiny remains focused on clear human efficacy, robust safety, and tolerability; preclinical promise alone has not been sufficient to de-risk approval. The estimated probability of approval (PoA) for EB-003 is 12.0%, reflecting the typical attrition rates observed in preclinical psychiatry programs, compounded by the translational uncertainties associated with its novel mechanism. This risk is partially offset by strong mechanistic novelty and encouraging early preclinical tolerability. A critical factor influencing the program's success will be its ability to advance into human dosing with a compelling safety profile and reproducible biomarkers or early efficacy signals. Key risks include the absence of human safety, pharmacokinetic, or efficacy data, the novelty of the mechanism, and the limited track record of Enveric as a small sponsor in late-stage development and regulatory processes. Read More | – | - | – | CAUTION | 8.30 | 0.81 | 27.70 K | 0.29% | |||
 BNTXBioNTech SE | 96.98 0.60% | +3.8% | 24.54 B | Phase 1/2 data presentation 2026-09-12 | pumitamig (BNT327/BMS986545) + elfetabart drozuntecan (elfe-D / BNT324/DB-1311) Advanced/metastatic SCLC and NSCLC | Phase 1/2 | 22% Pumitamig (BNT327/BMS986545) and elfetabart drozuntecan (BNT324/DB-1311) represent a promising investigational combination in the treatment of advanced/metastatic small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). Pumitamig is a PD-L1xVEGF-A bispecific antibody, while elfetabart drozuntecan is a B7-H3-targeting antibody-drug conjugate (ADC). This innovative program aims to leverage a "novel-novel" strategy that combines checkpoint inhibition and angiogenesis blockade with direct tumor cytotoxicity, thereby positioning itself as a first-in-class therapy rather than a me-too option. The global market for advanced/metastatic SCLC and NSCLC is substantial, estimated at $15 billion. Despite this significant market potential, there remains a considerable unmet need. Patients with advanced/metastatic SCLC and NSCLC experience high relapse rates, limited durable benefits in later treatment lines, and substantial resistance following chemotherapy, immunotherapy, and antibody-drug conjugates. This unmet need underscores the importance of developing effective therapies that can improve patient outcomes. Currently, the combination of pumitamig and elfetabart drozuntecan is undergoing evaluation in a global Phase 1/2 clinical trial, identified as NCT06892548. This trial is designed to establish safe combination doses, optimize dosing in NSCLC and SCLC cohorts, and evaluate preliminary efficacy. The open-label, multi-part trial structure allows for the establishment of two safe dose levels in Part 1, while Part 2 focuses on dose optimization in treatment-naïve NSCLC and relapsed/progressive SCLC. Expansion cohorts will assess proof-of-concept, although mature efficacy data, such as overall response rate (ORR), progression-free survival (PFS), and overall survival (OS), have not yet been reported. While the individual components of this combination have demonstrated activity in their respective indications, safety remains a critical concern. Each agent carries its own risk profile, and their combination may exacerbate potential side effects, including cytopenias, fatigue, gastrointestinal toxicity, infusion reactions, and immune-related pulmonary events. Therefore, careful consideration of tolerability and dose selection will be essential to the program's success. Regulatory designations for the advanced/metastatic SCLC and NSCLC indications have not been established, as all relevant designations are currently classified as false or unknown. Although BioNTech benefits from a strong partnership with Bristol Myers Squibb and has a solid track record in oncology development, this specific combination has not yet progressed to late-stage registrational trials. The competitive landscape in lung cancer suggests that the likelihood of approval will heavily depend on the depth of response, durability of effect, and manageable toxicity profiles. Programs that demonstrate strong signals in Phase 2 trials can advance rapidly if they show clinically meaningful benefits compared to historical benchmarks. However, combinations lacking randomized confirmation may face skepticism from regulatory bodies. The estimated probability of approval (PoA) for this combination stands at 22.0%. This figure reflects the promising biological activity and early signals from the individual agents, tempered by the challenges of early-stage development, the inherent risks of combining two novel agents, and uncertainties regarding the ability of this regimen to outperform existing treatment standards in chemotherapy and emerging ADCs. Read More | ±6% | -104.17 M | 7 +158% | — | 9.01 B | 70.48 M | 663.60 K | 0.92% |
• 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.