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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 26, 2026
Showing 11 Catalysts Out Of 1138. 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 BMYBristol-Myers Squibb Company | 61.33 -0.25% | -4.1% | 125.28 B | Phase 3 data presentation 2026-10-26 | Izalontamab brengitecan (iza-bren) EGFR-mutant non-squamous non-small cell lung cancer after progression on a third generation EGFR TKI (PANKU-Lung01) | Phase 3 | 35% Izalontamab brengitecan, also known as iza-bren, is an investigational bispecific antibody-drug conjugate being developed by SystImmune in collaboration with Bristol Myers Squibb. This innovative therapy targets both EGFR and HER3, delivering a cytotoxic payload through dual-antigen binding. This approach aims to enhance tumor selectivity and address the heterogeneous signaling often observed in EGFR-driven non-small cell lung cancer (NSCLC). The drug is positioned as a potential first-in-class EGFRxHER3 bispecific antibody-drug conjugate, distinguishing it from traditional EGFR inhibitors. The key clinical program for iza-bren is the PANKU-Lung01 study, a randomized Phase 3 trial designed to compare the efficacy of BL-B01D1/iza-bren against platinum-based chemotherapy in patients with locally advanced or metastatic NSCLC. However, the available evidence does not provide reliable details regarding the trial's NCT number, final enrollment figures, blinding status, primary and secondary endpoints, or comprehensive statistical design, necessitating caution in interpreting these aspects as unverified. Furthermore, there is a lack of mature, indication-specific data on Phase 3 outcomes such as overall response rate (ORR), progression-free survival (PFS), overall survival (OS), hazard ratios, confidence intervals, or p-values. In terms of regulatory status, the FDA granted Breakthrough Therapy Designation for a broader population of patients with EGFR exon 19 deletion or exon 21 L858R NSCLC who have progressed after treatment with an EGFR TKI and platinum-based chemotherapy. This designation was announced on August 18, 2025. However, it is important to note that this designation does not apply to the specific PANKU-Lung01 indication, which focuses on patients progressing after a third-generation EGFR TKI. Consequently, there are no confirmed Fast Track, Orphan Drug, Priority Review, or Accelerated Approval designations for PANKU-Lung01. The market analysis indicates a significant unmet need in the treatment landscape for patients who have progressed after third-generation EGFR TKIs, as these individuals often face limited durable targeted options and typically resort to chemotherapy, which presents substantial resistance and tolerability challenges. The global market size for the post-third-generation EGFR TKI treatment segment is estimated to be approximately $1.0 to $2.0 billion annually, although no reliable public source provides a precise indication-specific figure. Iza-bren is classified as a first-in-class therapy, contingent upon the absence of competing EGFRxHER3 bispecific ADCs receiving approval first. The estimated probability of approval (PoA) for the specific PANKU-Lung01 indication stands at 35.0%. This estimate reflects a meaningful biological rationale, the Breakthrough Therapy status in an adjacent population, and the substantial unmet need within this patient group. However, it is tempered by the lack of mature randomized efficacy data, uncertainties surrounding the exact Phase 3 design, potential safety risks associated with bispecific antibody-drug conjugates, and the rapidly evolving competitive landscape that includes other antibody-drug conjugates and targeted therapies addressing acquired resistance to EGFR TKIs. Key risks include the program's reliance on positive Phase 3 evidence, the broader FDA designation not aligning with the specific treatment history of the PANKU-Lung01 population, and the potential for significant safety concerns related to bispecific ADCs, such as interstitial lung disease, myelosuppression, and neuropathy. Additionally, the competitive environment is dynamic, with emerging therapies that may impact market positioning. Upcoming catalysts include the anticipated efficacy readout from the PANKU-Lung01 trial, regulatory interactions, and additional data from the global BL-B01D1-LUNG-101 study (NCT05983432). The PoA could increase significantly following a positive PFS result with manageable toxicity, but it would decrease sharply if the trial fails to meet its primary endpoint or reveals clinically significant safety issues. Read More | ±5.7% | -519.96 K | 3 -50% | PROFITABLE | 11.46 B | - | 3.79 M | 2.25% | ||
 MGNXMacroGenics, Inc. | 2.185 -2.89% | -46.4% | 139.18 M | Phase 2 data readout 2026-10-26 | Phase 2 | 12% Lorigerlimab (MGD019) is a dual-specificity bispecific antibody developed by MacroGenics that targets both PD-1 and CTLA-4, positioning it as a first-in-class immune-oncology mechanism distinct from conventional single-pathway checkpoint inhibitors. The primary focus of this analysis is the phase 2 LINNET study, which investigates the drug's efficacy in advanced gynecologic cancers, specifically targeting platinum-resistant ovarian cancer (PROC) and clear cell gynecologic cancers (CCGC). The LINNET trial is an open-label, non-randomized, multicohort study enrolling approximately 60 patients, with a distribution of up to 40 PROC patients and 20 CCGC patients. The primary endpoint of the study is the objective response rate (ORR), while secondary endpoints include progression-free survival (PFS) and duration of response (DoR). The trial is registered under NCT06730347 / CP-MGD019-03 and is classified as Phase II. The market for advanced gynecologic cancers is significant, with an estimated size ranging from $8 to $12 billion globally. There is a notable unmet need in this therapeutic area, particularly for conditions such as platinum-resistant ovarian cancer and clear cell gynecologic cancers, which are characterized by poor outcomes, limited durable responses to chemotherapy, and historically weak sensitivity to single-agent PD-1 blockade. Despite the potential market opportunity, the development status of lorigerlimab raises several concerns. Currently, no efficacy signal has been publicly reported for the gynecologic program, and the LINNET study is still ongoing. This lack of data is a critical limitation, as approval probability in oncology typically hinges on either robust randomized evidence or a strong single-arm response in settings with unmet needs. Regulatory risks are also prominent. The FDA previously imposed a partial clinical hold on the LINNET study following several serious safety events, including one treatment-related death, which heightens the approvability risk. Although the hold has since been lifted, the incident remains a material concern. Additionally, the biology of advanced gynecologic cancers presents inherent challenges, and the competitive landscape is crowded. Lorigerlimab must demonstrate meaningful efficacy against existing treatment standards and emerging competitors, as checkpoint-based therapies have yielded mixed results in these tumor types. As for regulatory designations, it is important to approach claims conservatively. The current analysis indicates that lorigerlimab does not have Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval designations for advanced gynecologic cancers. This lack of regulatory support underscores the challenges the program faces in gaining traction within a competitive environment. Looking ahead, several upcoming catalysts could influence the investment outlook for lorigerlimab. These include clinical updates from the LINNET study, potential data readouts from the ongoing trial, and any regulatory updates following the lifted partial hold. However, the absence of efficacy data and the previous safety concerns contribute to a low-double-digit probability of approval (PoA) of 12.0%. This PoA reflects the significant risks and uncertainties associated with the program, particularly in light of the competitive landscape and the historical performance of immunotherapies in unselected patient populations. Overall, while lorigerlimab presents an innovative approach to treating advanced gynecologic cancers, the path to approval remains fraught with challenges that investors should carefully consider. Read More | ±23.8% | -378.69 K | 3 +29% | CAUTION | 173.31 M | 13.58 M | 2.14 M | 11.46% | |||
 ORKAOruka Therapeutics, Inc. | 90.185 12.36% | -16.4% | 5.97 B | Phase 2b data readout 2026-10-26 | Phase 2b | 22% The available public evidence supports a Phase 2 program for ORKA-001, rather than a confirmed Phase 2b program. ORKA-001 is Oruka Therapeutics’ long-acting anti–IL-23p19 monoclonal antibody designed for the treatment of moderate-to-severe plaque psoriasis. Its primary potential advantage lies in its less-frequent dosing—possibly once or twice a year—rather than introducing a novel disease target. In terms of regulatory designations for moderate-to-severe plaque psoriasis, no public evidence identifies any of the following designations for ORKA-001: Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval. These should be treated as not publicly documented, rather than as definitive proof that the FDA has denied them. Market analysis indicates that the global market size for biologic treatments for moderate-to-severe plaque psoriasis is approximately $15 billion. There remains a significant unmet need, as existing biologics, while effective, do not fully address the demand for durable control, convenient dosing, treatment persistence, and options for patients experiencing incomplete response or loss of response. ORKA-001 is classified as best-in-class. The estimated probability of approval (PoA) for ORKA-001 stands at 22.0%. This estimate is contingent upon the program being in Phase 2 and employs a broad clinical-development probability framework. It is important to note that this is not a validated company forecast. Should ORKA-001 advance into a registrational Phase 3 program by October 25, 2026, the estimate would require a significant upward revision following a review of new trial data. Key risks associated with ORKA-001 include development-stage uncertainty, as public sources indicate ongoing Phase 2a and dose-ranging studies but do not confirm a completed Phase 2b or registrational trial. The competitive efficacy bar is also a concern, as existing IL-23p19 inhibitors, such as risankizumab, already demonstrate high rates of skin clearance. Therefore, the proposed annual or semiannual dosing must deliver compelling efficacy, durability, safety, and commercial value. Additionally, the long half-life of ORKA-001 raises concerns about the management of adverse effects, anti-drug antibodies, or treatment-related complications. Limited comparative evidence further complicates the picture, as current results are based on uncontrolled treatment-arm outcomes that do not yet demonstrate superiority or noninferiority against an approved active comparator. Lastly, while less frequent dosing may be clinically appealing, it could encounter payer, administration, and contracting barriers. Upcoming catalysts include results from the EVERLAST-B dose-ranging study and an update on dose selection, although the timing has not been disclosed. Further long-term safety, durability, and dosing-interval results from the ORKA-001 open-label extension (NCT07449702) are also anticipated, with timing yet to be announced. Additionally, updates on Phase 2 development or registrational trials are expected, though specific timelines remain undisclosed. In summary, ORKA-001 is a subcutaneously administered, humanized IgG1 monoclonal antibody targeting the p19 subunit of interleukin-23. By selectively blocking IL-23 signaling, it utilizes the same validated biological pathway as risankizumab and other approved IL-23p19 therapies. Its proposed differentiation lies in its pharmacokinetics, with an engineered extended half-life aimed at supporting dosing every six to twelve months, potentially enhancing convenience, persistence, and treatment durability. The evidence does not confirm the stated Phase 2b status, as public records identify the EVERLAST-A study as a randomized, double-blind, placebo-controlled Phase 2a trial, and EVERLAST-B as a randomized, double-blind, placebo-controlled dose-ranging study. EVERLAST-A enrolled 84 participants across 26 U.S. and Canadian sites, with a reported active-treatment population of 63 participants. The principal efficacy assessment was complete skin clearance, measured by PASI 100 at Week 16, where 40 of 63 ORKA-001-treated participants achieved PASI 100, equating to 63.5%. Week-28 results were also announced, but the available material lacks a complete set of placebo-adjusted response rates, p-values, confidence intervals, hazard ratios, or time-to-event analyses. Safety remains incompletely characterized, as available sources describe randomized safety evaluations but do not provide detailed adverse-event tables, serious-adverse-event rates, discontinuation rates, infection profiles, immunogenicity analyses, or exposure-adjusted event rates. This is particularly relevant for a long-acting antibody, as prolonged exposure can reduce dosing burden while complicating the management of adverse reactions. No psoriasis-specific Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval designations are publicly documented. ORKA-001 is best classified as best-in-class rather than first-in-class, as IL-23p19 inhibition is already clinically validated, with the proposed advantage being dosing frequency and potentially durable response. The global market for moderate-to-severe plaque psoriasis biologics is estimated at approximately $15 billion, with a meaningful unmet need persisting despite the availability of strong existing therapies. The principal precedent is the established IL-23p19 class, including risankizumab, whose approval reflects robust randomized efficacy and safety evidence rather than a new mechanism. ORKA-001 must demonstrate durable, reproducible clearance and acceptable safety while proving that infrequent dosing offers meaningful clinical or commercial value. The 22.0% probability of approval reflects promising early efficacy but substantial uncertainty surrounding dose selection, durability, long-term safety, comparative performance, manufacturing, and the absence of confirmed pivotal development. Read More | ±11.4% | -24.22 M | 14 +14% | HEALTHY | 1.13 B | 11.05 M | 1.63 M | 13.23% | |||
 AVBPArriVent BioPharma, Inc. | 15.181 -28.06% | -26.5% | 777.83 M | Phase 1 data presentation 2026-10-26 | ARR-217 (MRG007), CDH17-directed exatecan ADC Gastrointestinal cancers, locally advanced or metastatic solid tumors | Phase 1 | 12% ARR-217, also known as MRG007, is an antibody-drug conjugate (ADC) developed by ArriVent BioPharma, targeting CDH17 for the treatment of gastrointestinal cancers, including locally advanced or metastatic solid tumors. This drug is licensed from Lepu Biopharma for development and commercialization outside of greater China. The ADC comprises a humanized anti-CDH17 antibody linked via a glycan-based linker to exatecan, a topoisomerase-I inhibitor. CDH17 is predominantly expressed in gastrointestinal epithelial tumors, particularly colorectal cancers, while its limited distribution in normal tissues is designed to enhance tumor selectivity. Despite its mechanistic differentiation from traditional chemotherapy, clinical validation remains pending. The gastrointestinal cancer therapeutics market is projected to reach approximately $30 billion globally between 2024 and 2026. This figure encompasses the broader oncology treatment landscape rather than a specific market for ARR-217's biomarker-defined population. While the drug is classified as potentially best-in-class, it is important to note that no comparative clinical evidence has yet established its superiority over existing therapies. The estimated probability of approval (PoA) for ARR-217 stands at 12.0%. This figure represents an indication-level estimate for regulatory approval based on the current Phase 1 development stage, assuming continued progress in treating unresectable, locally advanced, or metastatic gastrointestinal tumors. It does not reflect the likelihood of success in the next trial or guarantee approval across all tumor types. Key risks associated with ARR-217 include early-stage clinical uncertainty, as the drug is still in Phase 1 and lacks mature efficacy data, including objective response rates (ORR), duration of response, progression-free survival (PFS), overall survival (OS), hazard ratios, confidence intervals, and p-values. Additionally, the potential toxicity associated with the exatecan/topoisomerase-I payload raises concerns regarding dose-limiting hematologic, gastrointestinal, hepatic, and possibly pulmonary toxicities. The necessity for clinical validation of CDH17 expression and on-target/off-tumor exposure further complicates the risk profile. The competitive landscape is crowded, with ARR-217 needing to contend with both established and emerging therapies targeting HER2, TROP2, Claudin 18.2, EGFR, BRAF, KRAS, and other biomarkers, as well as irinotecan- and topoisomerase-I-based ADCs. Furthermore, the assertion of being "best-in-class" remains unvalidated, primarily supported by mechanistic and preclinical rationale without randomized clinical comparisons. Lastly, the partnership with Lepu Biopharma introduces execution risks, as ArriVent must navigate global development while managing other programs. Upcoming catalysts for ARR-217 include the first public Phase 1 clinical readout at the 2026 ESMO Congress, with the specific presentation date yet to be disclosed. An ongoing Phase 1 dose escalation and expansion study is underway, although the timing for interim or topline data has not been revealed. Additionally, there is potential for initiating a combination therapy study with MRG007 in advanced colorectal cancer (NCT07737600), which is currently listed as not yet recruiting. In summary, ARR-217 represents a significant opportunity within the gastrointestinal oncology therapeutics market, which is characterized by a substantial unmet need due to the high rates of relapse following standard treatments. While the drug is positioned as potentially best-in-class, the competitive landscape and the absence of mature clinical data necessitate caution. The 12.0% PoA reflects both the promising biological rationale and the considerable unmet need, tempered by the uncertainties inherent in early-stage development and the complexities of ADC safety and competitive dynamics. The primary valuation catalyst will be the ESMO 2026 first clinical readout, followed by data from ongoing studies and potential developments in combination therapies. Read More | ±36.6% | - | 7 +18% | HEALTHY | 373.12 M | 13.19 M | 4.57 M | 22.84% | ||
 ZLABZai Lab Limited | 24.27 1.12% | -2.2% | 2.76 B | Phase 1b/1c data presentation 2026-10-26 | Zocilurtatug pelitecan (zoci, formerly ZL-1310) First-line extensive-stage small cell lung cancer (ES-SCLC) Fast TrackOrphan | Phase 1b | 18% Zocilurtatug pelitecan, or zoci, previously known as ZL-1310, is an investigational DLL3-directed antibody-drug conjugate developed by Zai Lab for the treatment of small cell lung cancer (SCLC). This drug targets delta-like ligand 3 (DLL3), a protein frequently expressed in SCLC, and is designed to deliver a cytotoxic payload selectively to DLL3-positive tumor cells. Zai Lab positions this program as potentially first-in-class among DLL3-targeted ADCs, although it is more accurately described as first-in-class rather than best-in-class due to the lack of mature head-to-head evidence against other approved DLL3 ADCs. The current development status includes an ongoing global Phase 1a/1b study, registered as NCT06179069. The first-line extensive-stage small cell lung cancer (ES-SCLC) evaluation is a Phase 1b investigation assessing zoci in combination with atezolizumab, with or without carboplatin. Publicly available information does not confirm a randomized, placebo-controlled, or blinded study design; instead, the reported cohorts appear exploratory and nonrandomized. Consequently, the available results should be interpreted as preliminary signal-finding rather than confirmatory evidence. At the recommended dose of 1.6 mg/kg, the zoci-atezolizumab combination achieved a confirmed investigator-assessed overall response rate (ORR) of 81.8% in 33 patients, with a 95% confidence interval of 64.5% to 93.0%. The six-month progression-free survival (PFS) rate was reported at 81.9%. However, no mature median overall survival (OS) data, randomized PFS comparisons, or OS hazard ratios have been disclosed. In a separate cohort of 13 patients receiving the triplet therapy of zoci, atezolizumab, and carboplatin, a 92.3% ORR was observed, with a median PFS of 8.4 months and a median duration of response of 7.7 months, although this cohort included multiple dose levels. The preliminary tolerability profile of the doublet therapy was encouraging, with no dose-limiting toxicities reported during the escalation phase and no treatment-related discontinuations. Grade 3 or higher adverse events related to zoci occurred in 9.1% of patients at the 1.6 mg/kg dose. Common treatment-emergent events included anemia, nausea, leukopenia, neutropenia, decreased appetite, elevated ALT, and lymphopenia. In contrast, the triplet therapy presented a less favorable safety profile, with Grade 3 or higher adverse events occurring in 76.9% of the 13 patients. Despite the promising early data, the program does not currently hold any Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval designations for the first-line ES-SCLC indication, as no public evidence confirms these designations. The indication presents a significant unmet need, as the standard treatment of platinum-etoposide combined with PD-L1 immunotherapy often results in limited durable control, with relapse and treatment toxicity being common issues. The global market for first-line ES-SCLC therapy is estimated to be approximately $2-4 billion, although no specific company-related market estimates have been identified. The primary competitive benchmark for zoci is the combination of atezolizumab or durvalumab with platinum-etoposide. To successfully displace this standard, zoci must demonstrate more than just a high early ORR. Additionally, DLL3-targeted approaches face competition from non-ADC agents and other investigational DLL3 therapies. Regulatory precedents favor randomized evidence, mature survival benefits, and manageable toxicity profiles, as accelerated approvals in oncology typically depend on robust response data followed by mandatory confirmatory trials. The estimated probability of approval (PoA) for zoci stands at 18.0%. This estimate reflects the strong early response signal, apparent tolerability of the doublet, biologically rational targeting, and the substantial unmet need in the disease area. However, the probability remains below typical late-phase estimates due to the limited evidence from a small Phase 1b cohort, the absence of a control arm, a lack of mature OS data, and concerning toxicity signals associated with the triplet therapy. Key upcoming catalysts include additional follow-up data, the selection of a definitive treatment regimen, and the initiation of a randomized registrational study. Read More | ±18.4% | -235.15 K | 4 +44% | HEALTHY | 617.52 M | 21.14 M | 1.26 M | 6.82% | ||
 ALNYAlnylam Pharmaceuticals, Inc. | 227.87 1.79% | -10.4% | 30.49 B | Phase 1b data presentation 2026-10-26 | Phase 1b | 12% Brezosiran, previously known as ALN-HTT02, is an investigational intrathecal RNA interference (RNAi) therapy being developed by Alnylam Pharmaceuticals for the treatment of Huntington's disease. This therapy utilizes Alnylam’s proprietary C16 conjugate platform to deliver RNAi directly into the central nervous system, aiming to reduce levels of mutant huntingtin, the pathogenic protein associated with the expanded HTT gene. Given that no approved therapies for Huntington's disease currently employ this specific mechanism, brezosiran is classified as first-in-class rather than best-in-class or me-too. The market analysis for Huntington's disease indicates a significant unmet need, as existing treatments primarily focus on managing chorea and psychiatric symptoms without providing disease modification or effectively halting neurodegeneration. While specific market size figures remain undisclosed and unverifiable, the need for effective therapies is clear. Brezosiran's potential differentiation lies in its infrequent dosing schedule, possibly every six months, and its ability to engage targets durably, although these advantages are still under preliminary investigation. As of October 23, 2026, brezosiran is in an ongoing Phase 1b clinical trial, which is randomized, double-blind, placebo-controlled, and designed as a single-ascending-dose study. The trial has enrolled 48 participants across five evaluated dose cohorts, with an additional cohort of 12 participants still in the enrollment phase. The study population consists of adults aged 25 to 70 years with genetically confirmed Huntington's disease, specifically those in HD-ISS Stage 2 or early Stage 3. The trial's objectives include assessing safety, tolerability, pharmacokinetics, pharmacodynamics, and various exploratory measures related to disease progression. However, it is important to note that no validated clinical efficacy endpoints have been reported, and the trial has not yet provided a verified NCT number. Initial biomarker results from the trial have shown promise, with a mean reduction of approximately 60% to 64% in CSF mutant huntingtin levels from baseline at Month 3 for the highest evaluated dose, and a maximum individual reduction of 83%. While durability of these effects has been reported through follow-up of up to 12 months, these findings do not yet establish a slowed clinical progression. Moreover, the preliminary dataset did not indicate a dose-dependent increase in inflammatory markers or other safety concerns, although detailed adverse-event data remain unavailable. Regulatory designations for brezosiran have not been established, as there are no identified Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval designations specific to Huntington's disease. The absence of these designations reflects the ongoing investigational status of the program. Key risks associated with brezosiran include the potential disconnect between biomarker reduction and clinical outcomes, safety concerns related to intrathecal administration, and the challenges inherent in conducting pivotal trials for Huntington's disease, which often face slow progression and heterogeneous patient phenotypes. The estimated probability of eventual approval for brezosiran stands at 12.0%. This figure accounts for the promising early pharmacodynamic activity and the experience of the sponsor, balanced against the program's early development stage, the lack of clinical outcome evidence, and the historical difficulties in translating biomarker reductions into meaningful functional benefits. Upcoming catalysts include the completion of the Dose 6 cohort, the reporting of longer-term extension data, and the initiation of a pivotal study planned for 2027, pending regulatory alignment. Read More | ±12.4% | -398.86 K | 7 +268% | PROFITABLE | 3.31 B | - | 1.05 M | 5.78% | |||
 ORICOric Pharmaceuticals, Inc. | 9.05 -31.47% | +4.1% | 1.03 B | Phase 1b data presentation 2026-10-26 | Phase 1b | ±39.1% | -2.02 M | 10 -11% | HEALTHY | 387.56 M | 10.54 M | 5.66 M | 23.92% | ||||
 SMMTSummit Therapeutics Inc. | 14.515 -6.24% | -16.0% | 11.58 B | Phase 2 data presentation 2026-10-26 | Phase 2 | ±13.6% | - | 5 +1% | CAUTION | 690.68 M | 47.04 M | 3.82 M | 27.03% | ||||
 AZNAstraZeneca PLC | 171.385 -0.04% | +4.7% | 265.80 B | Phase 3 data presentation 2026-10-26 | osimertinib (TAGRISSO) plus savolitinib treatment‑naïve MET‑overexpressed, EGFRm locally advanced or metastatic NSCLC (China) | Phase 3 | ±7.8% | 3.25 K | 1 -33% | — | 5.72 B | - | 1.85 M | 0.17% | |||
AZNAstraZeneca PLC | 171.385 -0.04% | +4.7% | 265.80 B | Phase 1 data presentation 2026-10-26 | Phase 1 | ±7.8% | 3.25 K | 1 -33% | — | 5.72 B | - | 1.85 M | 0.17% | ||||
BMYBristol-Myers Squibb Company | 61.33 -0.25% | -4.1% | 125.28 B | Phase 2 data presentation 2026-10-26 | Izalontamab brengitecan (iza-bren) EGFR mutant locally advanced or metastatic NSCLC, iza-bren plus osimertinib (Phase 2) | Phase 2 | ±5.7% | -519.96 K | 3 -50% | PROFITABLE | 11.46 B | - | 3.79 M | 2.25% |
• 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.