FDA Calendar 2026 Upcoming FDA Approval Dates & PDUFA Dates
Track every upcoming FDA approval date, PDUFA date, and biotech catalyst in one place. Our free FDA calendar is updated daily with clinical trial readouts, advisory committee meetings, drug approval decisions, and next FDA meeting dates for 2026. Built for biotech investors who need to stay ahead of stock-moving regulatory events.
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Showing 6 Catalysts Out Of 981. Click On The Tickers For More Details
AJ1-11095, also referred to as AJX-101, is an early-stage program targeting myelofibrosis in patients who have experienced failure with a type I JAK2 inhibitor. However, due to the lack of verifiable public trial, regulatory, or designation data, any specific probability of approval, market figures, or designation status would be speculative rather than evidence-based. The regulatory designations for myelofibrosis in this context indicate that AJ1-11095 does not currently hold any of the following statuses: Fast Track Designation, Orphan Drug Designation, Breakthrough Therapy Designation, Priority Review, or Accelerated Approval, as outlined in the provided data. Market analysis reveals that while the unmet need in this setting is significant, the specific market size remains unknown due to the absence of supporting sources. Myelofibrosis following the failure of a type I JAK2 inhibitor is widely recognized as a high-unmet-need area, characterized by persistent splenomegaly, constitutional symptoms, cytopenias, and limited treatment options. However, without concrete data, a precise global market-size estimate cannot be provided. The drug classification for AJ1-11095 is also currently unknown. The estimated probability of approval for AJ1-11095 stands at 5.0%. This figure reflects the substantial uncertainty surrounding the asset, particularly given its early development stage. Key risks associated with this program include the absence of a verifiable clinical dataset, which leaves the efficacy and safety of AJ1-11095 unproven. The high-risk nature of early-phase development, especially in a refractory myelofibrosis population, adds to the uncertainty. Furthermore, competitive and regulatory risks are significant, as the myelofibrosis landscape is populated with established JAK-inhibitor therapies, and regulatory bodies typically require compelling evidence of benefit in terms of spleen/symptom improvement and survival. Looking ahead, there are several upcoming catalysts for AJ1-11095, including an initial clinical readout, a Phase 1/2 expansion update, and potential regulatory interactions or designation announcements. However, the timing for these events has not been disclosed. In summary, AJ1-11095 represents an early-stage program in a challenging clinical setting. Given the lack of verifiable information regarding the asset’s modality, sponsor history, trial design, and regulatory designations, the program must be regarded as unvalidated from an approval standpoint. While the myelofibrosis setting after JAK inhibitor failure presents a meaningful unmet need, the absence of confirmed clinical data limits the ability to classify the asset definitively. The probability of approval is low by base-rate standards, particularly as the program is currently in Phase 1. Early-phase oncology and hematology programs often face high attrition rates due to inadequate efficacy or dose-limiting toxicity. In the context of myelofibrosis, differentiation typically requires evidence of spleen volume reduction, symptom improvement, and management of anemia or cytopenia. Without reported response rates or other critical efficacy data, the basis for a higher probability of approval is lacking. In conclusion, the estimated probability of approval for AJ1-11095 remains at 5.0%, reflecting the early-stage nature of the asset and the substantial unknowns that accompany it, rather than an assertion regarding the intrinsic quality of the drug. Read More
LB2501, associated with LEGN, is purportedly being developed for relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). However, the evidence provided does not substantiate the existence of an active LB2501 program under LEGN. Instead, the search results highlight other lymphoma assets and trials, such as GLPG5101 and LTZ-301, while failing to identify a publicly documented LB2501 initiative in R/R B-NHL. Consequently, the most defensible estimate of the probability of approval (PoA) is low, at 5.0%, reflecting substantial uncertainty primarily due to the absence of verifiable clinical and regulatory evidence. In terms of regulatory designations for R/R B-NHL, LB2501 does not currently hold any special designations, as indicated in the following data: ```json { "FastTrackDesignation": false, "OrphanDrugDesignation": false, "BreakthroughTherapyDesignation": false, "PriorityReview": false, "AcceleratedApproval": false } ``` From a market analysis perspective, the global market size for R/R B-NHL and related therapies is estimated to be between $10 billion and $15 billion. There is a significant unmet need in this area, as median overall survival after the failure of multiple prior therapies can be as short as a few months. Many patients do not achieve a cure with currently approved treatments, including CAR-T therapies, bispecific antibodies, antibody-drug conjugates, and chemoimmunotherapy options. The drug classification for LB2501 remains unknown. The key risks associated with LB2501 include the inability to verify the program's identity, which raises concerns about its legitimacy. Additionally, there is a clinical efficacy risk, as no verifiable phase 1 efficacy data, including overall response rate (ORR), progression-free survival (PFS), overall survival (OS), or response durability, have been provided for LB2501. Furthermore, the competitive landscape for R/R B-NHL is crowded, with numerous active modalities that have established efficacy, making differentiation challenging. Upcoming catalysts for LB2501 include a phase 1 safety and efficacy readout, although the timing has not been disclosed. There may also be potential for dose-escalation expansion or a phase transition, but again, the timing remains unspecified. In summary, while LB2501 is listed as a LEGN program for R/R B-NHL, the lack of verifiable evidence raises significant doubts about its development status. The clinical context indicates that R/R B-NHL is a serious condition with a notable unmet need, as median overall survival can be as low as six to ten months in certain patient populations. However, without a confirmed trial record, NCT number, enrollment status, or efficacy/safety readout for LB2501, the clinical development status remains unverified. This uncertainty significantly undermines confidence in any approval forecasts. In the standard biotech diligence framework, a first-in-human or phase 1 oncology asset lacking public response data typically carries a low probability of eventual approval unless it demonstrates exceptionally strong early efficacy or a compelling safety profile, neither of which can be substantiated for LB2501. Competitive positioning for LB2501 must consider established therapies in R/R B-NHL, including CAR-T products, CD20/CD3 bispecific antibodies, and regimens like polatuzumab-based combinations and tafasitamab/lenalidomide. Any new entrant would need to demonstrate superior response rates, durable complete remissions, meaningful convenience advantages, or a cleaner safety profile. Without a confirmed mechanism of action for LB2501, it cannot be confidently classified as first-in-class, best-in-class, or me-too. The absence of indication-specific FDA designations for LB2501 in R/R B-NHL further compounds the uncertainty, as no approval or rejection history or partnership track record has been established. The 5.0% PoA reflects the extreme uncertainty and typical attrition risk associated with an unverified phase 1 oncology program. The primary risks include the lack of program confirmation, absence of public human data, and the high efficacy bar in an indication with multiple active approved therapies. Read More
ELVN-001 is an oral, highly selective active-site BCR::ABL1 inhibitor designed to target chronic myeloid leukemia (CML) at the kinase driver level, demonstrating activity against T315I and resistance-associated mutations. This mechanism distinguishes it from approved ATP-competitive tyrosine kinase inhibitors (TKIs) and allosteric inhibitors such as asciminib, allowing it to be classified as first-in-class rather than me-too or merely best-in-class. The estimated probability of approval (PoA) for ELVN-001 stands at 24.0%. The global market for relapsed or refractory previously treated chronic-phase CML is projected to be between $2 billion and $4 billion. There remains a significant unmet need in this space, particularly for patients who fail or cannot tolerate multiple TKIs, especially those with T315I or multi-resistant disease, as they have limited durable options despite existing therapies. Currently, ELVN-001 is in Phase 1 development, specifically within the ENABLE trial (ELVN-001-101 / NCT05304377), which is an open-label, multicenter Phase 1a/1b dose-escalation and expansion study. This trial is focused on adults with CP-CML who are relapsed, refractory, or intolerant to prior TKIs. The study is actively recruiting and aims to identify recommended expansion doses while assessing safety, pharmacokinetics, and changes in BCR-ABL1 transcript burden. Additionally, a Japan-specific Phase 1 study (NCT06787144) has commenced, although the core evidence base remains anchored in the ENABLE trial. Efficacy data reported thus far are promising but still immature. Publicly available information indicates a major molecular response (MMR) rate of approximately 44% to 47% at 24 weeks, with responses observed even in heavily pretreated patients, including those previously exposed to ponatinib or asciminib. However, as this is a Phase 1 single-arm study, no randomized comparator data or public hazard ratios, p-values, overall survival (OS), or progression-free survival (PFS) metrics are available. Safety data appears favorable, with no maximum tolerated dose (MTD) identified, a lack of clear dose-toxicity relationships, low rates of dose reductions and discontinuations, and a reported 6.4% discontinuation rate due to adverse events in the EHA 2026 update. The primary adverse events noted are hematologic, including thrombocytopenia and neutropenia, with no significant cardiovascular signals reported. In terms of regulatory designations for previously treated CP-CML, ELVN-001 has received orphan drug designation, although there is no public evidence of Fast Track, Breakthrough Therapy, Priority Review, or Accelerated Approval for this specific indication. The competitive landscape for CP-CML is challenging, as multiple effective TKIs and asciminib already address most of the patient population. The unmet need is particularly pronounced in cases of multi-resistant, intolerant, and T315I-mutant disease. Successful precedents in this setting, such as asciminib, have demonstrated the importance of a differentiated mechanism and meaningful activity after prior TKI treatment. Overall, while ELVN-001's PoA is above average for a Phase 1 program due to its targeting of a validated pathway, encouraging early molecular responses, and favorable tolerability, the lack of controlled data and the necessity for durable benefit in a competitive market contribute to the estimate remaining in the mid-20% range. Read More
Divesiran (SLN124) is a first-in-class GalNAc-conjugated small interfering RNA (siRNA) developed by Silence Therapeutics (NASDAQ: SLN) for the treatment of polycythemia vera (PV), a rare myeloproliferative neoplasm. The drug targets TMPRSS6, a negative regulator of hepcidin, to increase hepcidin production and suppress red blood cell production, thereby addressing the underlying pathophysiology of PV. This innovative mechanism distinguishes divesiran from existing therapies that primarily inhibit the JAK2 pathway. The global market for polycythemia vera is estimated to be between $1.2 billion and $1.8 billion, driven by a patient population of approximately 100,000 to 150,000 worldwide. There is a significant unmet medical need in this area, as current first-line management relies heavily on phlebotomy, an invasive and burdensome procedure. Existing pharmacological options, including hydroxyurea, ruxolitinib, and peginterferon alfa-2a, face challenges such as resistance, variable efficacy, and toxicity concerns. Divesiran aims to alleviate these issues by providing a subcutaneously administered treatment that reduces the frequency of phlebotomy. Currently, divesiran is in Phase 1/2 clinical development, with results from the SANRECO trial (NCT05499013) showing promising outcomes. The open-label, dose-escalation study has enrolled 21 patients across three dose cohorts (3, 6, and 9 mg/kg), with administration every six weeks for four doses. The trial includes a 34-week treatment period followed by a 16-week follow-up, focusing on safety, tolerability, and preliminary efficacy. The efficacy data from Phase 1 are compelling, demonstrating a 94% reduction in phlebotomy frequency—from 79 phlebotomies pre-treatment to just 5 during treatment and 2 to 4 during follow-up. Notably, three patients with baseline hematocrit levels below 45% required no phlebotomies post-treatment. Mean hematocrit levels decreased across all dose cohorts, with sustained reductions observed through Day 232. Additionally, hepcidin induction was confirmed in all patients, and ferritin levels increased, indicating improved iron metabolism. Hematological parameters remained stable, with platelet counts increasing and white blood cell counts stable across cohorts. The safety profile of divesiran is exceptional for a Phase 1 study, with 83% of treatment-emergent adverse events classified as Grade 1 (mild). The most common adverse event was injection site reaction, affecting 66.7% of patients. Importantly, no dose-limiting toxicities, serious adverse events, or treatment-related discontinuations were reported, significantly de-risking the development program. Divesiran is classified as a first-in-class therapy, with no other approved drugs targeting TMPRSS6 for any indication. Although polycythemia vera qualifies for orphan drug status, there is no documented evidence of Fast Track, Breakthrough Therapy, or Priority Review designations for divesiran, indicating that the FDA views this development as standard. The competitive landscape includes approved therapies such as ruxolitinib, peginterferon alfa-2a, and hydroxyurea, as well as pipeline competitors. However, divesiran's novel mechanism, outstanding safety profile, and convenient dosing regimen (every six weeks) provide a distinct advantage over existing options. Historical precedents, such as ruxolitinib's approval based on Phase 2 data for myelofibrosis and subsequent approval for PV, underscore the importance of demonstrating a favorable safety-efficacy balance for FDA approval. The probability of approval (PoA) for divesiran is estimated to be between 32% and 42%. This estimate reflects a balanced risk-benefit assessment. Positive factors include the exceptional safety profile observed in Phase 1, a clear efficacy signal with significant reductions in phlebotomy frequency, confirmed target engagement, and the first-in-class mechanism addressing a substantial unmet need. However, challenges remain, including the early development stage, small sample size, open-label design, and the absence of expedited regulatory designations, which may necessitate Phase 3 trials. Investors should consider divesiran as a high-risk, high-reward opportunity. If successful, it could establish a first-in-class, differentiated therapy in an underserved rare disease market with significant commercial potential. However, the early development stage, regulatory uncertainties, and sponsor scale present material risks. Upcoming catalysts, including Phase 2 initiation and interim data, will be crucial in validating the investment thesis. In conclusion, divesiran represents a promising advancement in the treatment of polycythemia vera, with the potential to transform patient management through its innovative mechanism and favorable safety profile. The ongoing clinical development will be closely monitored as it progresses toward potential regulatory approval. Read More
Etentamig (ABBV-383) is an investigational BCMAxCD3 bispecific antibody developed by AbbVie for the treatment of relapsed/refractory immunoglobulin light chain (AL) amyloidosis, a rare plasma-cell disorder characterized by the deposition of toxic light chains in various organs. The current development program is in an open-label phase 1/2 study known as M24-209, which is registered in Japan under jRCT2071230131 and cross-referenced to NCT06158854. This study aims to evaluate the safety and efficacy of etentamig in patients with AL amyloidosis. The design of the study consists of two parts: dose escalation followed by dose expansion. However, available public sources do not indicate any randomization, placebo control, or blinding, which aligns with the exploratory nature of this early-stage trial. As of the analysis date, there are no published efficacy results for AL amyloidosis from this program, including overall response rate (ORR), progression-free survival (PFS), overall survival (OS), hazard ratios, p-values, or confidence intervals. This lack of data limits confidence in estimating the probability of approval (PoA), which is currently set at 18.0%. Consequently, the assessment relies heavily on class-level logic and the maturity of the program. A significant safety concern arises from the underlying mechanism of ABBV-383 as a T-cell engager, which is associated with risks such as cytokine release syndrome (CRS), infections, and cytopenias. While pooled phase 1 data from multiple myeloma suggest a manageable safety profile, with low incidences of grade 3/4 infections and durable responses, these results are not directly applicable to AL amyloidosis and should be viewed as supportive rather than predictive. Regarding regulatory designations for relapsed/refractory AL amyloidosis, there is no evidence of FDA Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval status for this indication. Although AbbVie may hold orphan status or other designations for different indications within its portfolio, these do not apply to this specific program. The absence of indication-specific designations modestly reduces the PoA, although the rarity and severity of AL amyloidosis could still support expedited regulatory pathways if compelling organ-response data emerge. From a commercial perspective, the market for relapsed/refractory AL amyloidosis is relatively small, with an estimated global drug sales opportunity of approximately $0.3 billion. This figure reflects the rarity of the disease and the limited treatable population. The unmet need is significant, as relapse following treatment with proteasome inhibitors, anti-CD38 therapies, alkylators, and stem-cell approaches is common, and there is currently no established disease-specific standard for refractory cases. Mechanistically, etentamig is positioned as a first-in-class therapy for AL amyloidosis, as BCMA-directed T-cell redirection is novel in this context, even though it is not unprecedented across hematologic malignancies. AbbVie has a mixed but generally credible development track record, with a strong history of late-stage approvals in immunology, oncology, and neuroscience. However, ABBV-383 remains an investigational asset without prior approvals in AL amyloidosis. The program benefits from AbbVie’s experience in bispecifics and oncology execution. Historical precedents indicate that FDA decisions in this therapeutic area are heavily influenced by durable hematologic responses, organ-response evidence, tolerability in frail patients, and effective management of infections and CRS. Given these considerations, the mid-teens PoA is deemed appropriate until the program can demonstrate convincing efficacy and safety specific to AL amyloidosis. Read More
Venetoclax (VENCLEXTA®), marketed by AbbVie, is an oral BCL-2 inhibitor that induces apoptosis in chronic lymphocytic leukemia (CLL) cells by antagonizing the anti-apoptotic BCL-2 protein. As a first-in-class agent, it was the first BCL-2 inhibitor approved for CLL and continues to define the mechanistic landscape of this therapeutic class. The current development status for previously untreated CLL indicates that the drug is effectively approved rather than still in Phase 3 trials. The Phase 3 AMPLIFY trial (NCT03836261) supported FDA approval of the fixed-duration combination of venetoclax and acalabrutinib in February 2026 for adults with previously untreated CLL/SLL. This regimen represents the first all-oral, fixed-duration first-line CLL option approved in the U.S. The AMPLIFY trial was a randomized Phase 3 study that compared the venetoclax-acalabrutinib combination against standard chemoimmunotherapy regimens (FCR or BR, depending on patient characteristics). According to communications from AbbVie and the FDA, the combination demonstrated a 35% reduction in the risk of disease progression or death compared to chemoimmunotherapy, with a hazard ratio of 0.65 (95% CI 0.49–0.87; p=0.0038). However, publicly available data do not provide a complete overview of the overall response rate (ORR), progression-free survival (PFS), or overall survival (OS) metrics, and OS data remains immature or unreported. Safety profiles for the first-line combination were consistent with known effects, reporting a tumor lysis syndrome incidence of 0.3% and no new safety signals. In terms of regulatory designations for previously untreated CLL, the combination has received orphan drug designation, while Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval designations were not supported for this indication. It is important to note that earlier breakthrough, priority, or accelerated approvals for venetoclax were granted for different indications and do not apply here. The market for CLL treatment is substantial, with a global market size estimated at $8.5 billion. Despite improvements in outcomes with BTK inhibitors and fixed-duration venetoclax-based regimens, there remains a significant unmet need for deeper and more durable remissions, lower cumulative toxicity, and time-limited therapy options that alleviate long-term treatment burdens. The competitive landscape for first-line CLL therapies is intense, primarily dominated by BTK inhibitors and their combinations. Venetoclax's strategic advantage lies in its ability to provide time-limited, deep-remission therapy, addressing a pressing unmet need, as many patients still require prolonged treatment and face cumulative toxicity. Key risks associated with the venetoclax-acalabrutinib regimen include safety concerns related to class effects, particularly tumor lysis syndrome and myelosuppression, which could impact market uptake and labeling. Additionally, competitive displacement from BTK inhibitor-based regimens and newer combinations may limit commercial potential even post-approval. There is also a risk of an evidence ceiling, where the long-term overall survival or minimal residual disease (MRD) depth advantages may not continue to mature favorably, narrowing the program's differentiation. Upcoming catalysts include additional overall survival and duration-of-response updates from the AMPLIFY trial, as well as regulatory and health technology assessment decisions in Europe and other regions for the venetoclax-acalabrutinib combination. The timing for these updates has not been disclosed. Given AbbVie's strong regulatory track record with venetoclax in CLL, the robust basis of the randomized Phase 3 trial, the clinically meaningful PFS benefit observed, and the absence of new major safety signals, the probability of approval (PoA) for the previously untreated CLL program is estimated at 99.0%. This assessment acknowledges that the program is already approved in the U.S., with remaining risks primarily related to post-approval commercial dynamics and label expansion rather than binary approval risks. Read More
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