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.
Price
Change In Price
Date
Select
Select
Select
Select
Event Type
Select
Showing 6 Catalysts Out Of 974. Click On The Tickers For More Details
SAB-142 is SAB Biotherapeutics’ lead asset targeting type 1 diabetes (T1D), a fully human anti-thymocyte immunoglobulin (hIgG) designed to delay the onset and progression of this autoimmune disease by modulating the immune response against pancreatic beta cells. As a first-in-class therapy, SAB-142 is positioned as a novel fully human alternative to rabbit anti-thymocyte globulin (ATG), aiming to preserve the same disease-modifying concept while potentially improving redosing and tolerability. The program has progressed beyond pre-clinical stages into human studies, with a first-in-human Phase 1 trial reported in Australia in October 2023. Currently, a Phase 2b study, named SAFEGUARD (NCT07187531), is underway, featuring a randomized, placebo-controlled, investigator- and participant-blinded design involving 159 participants across three arms: high-dose SAB-142, low-dose SAB-142, and placebo. The T1D market presents a significant opportunity, estimated at $30-35 billion globally. This figure reflects the ongoing chronic use of insulin, glucose-monitoring technologies, and the large population currently receiving treatment. However, a critical unmet need persists, as there remains no approved disease-modifying therapy that reliably prevents the onset of T1D or preserves beta-cell function at scale. The absence of such therapies underscores the importance of demonstrating a clear clinical benefit over existing insulin-centric care and other immune-modulating approaches currently in development. SAB-142 is still in the early clinical stage, having only reached first-in-human and early Phase 2 development. Consequently, there is no established proof of efficacy, and the primary uncertainty revolves around whether the biologic activity observed will translate into clinically meaningful beta-cell preservation. Additionally, the program carries inherent risks associated with safety and immunosuppression. As an anti-thymocyte immunoglobulin, there are central risks related to infection, immune suppression, and infusion-related toxicities. The trial protocol explicitly excludes patients with recent serious infections and significant liver disease, indicating a cautious approach to managing these risks. Furthermore, while rabbit ATG has demonstrated biologic and clinical activity in T1D, it does not guarantee that SAB-142 will achieve a superior benefit-risk profile or reproducible efficacy in the target population. Upcoming catalysts for SAB-142 include enrollment and interim progress updates from the Phase 2b SAFEGUARD study, with timing yet to be disclosed. Additionally, top-line efficacy and safety data from the Phase 2b study are anticipated by December 31, 2028. Further clinical updates from the SAB-142-101 early T1D study are also expected, although specific timelines remain undisclosed. In terms of regulatory designations, there is no public evidence of Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval for SAB-142 in the context of T1D, suggesting that these designations should be treated as false in the absence of public notice. Given the current evidence, a probability of approval (PoA) of 22.0% is justified. This figure reflects a higher likelihood than that of an unvalidated preclinical asset, as the mechanism has class support and the program has entered controlled human testing. However, it remains significantly lower than late-phase assets due to the lack of human efficacy proof and the high bar for safety and durable disease modification that SAB-142 must clear. Overall, while the potential for SAB-142 exists within a substantial market, the path forward is fraught with challenges that must be navigated carefully. Read More
Clearmind Medicine Inc. (CMND) is advancing CMND-100, a proprietary oral, non-hallucinogenic drug candidate derived from 5-methoxy-2-aminoindane (MEAI), a psychoactive compound structurally akin to MDMA. This innovative drug is designed to modulate reward mechanisms in the brain, aiming to produce an alcohol-like euphoric effect that could effectively reduce cravings and consumption in patients suffering from Alcohol Use Disorder (AUD). Unlike traditional psychedelics, CMND-100 seeks to provide a breakthrough non-hallucinogenic profile, targeting addictive behaviors without inducing perceptual distortions. The market for AUD represents a substantial global opportunity, estimated at $15 billion. This market is characterized by a high prevalence of affected individuals, with millions suffering worldwide, and a significant unmet need. Current treatment options, including naltrexone, acamprosate, and disulfiram, demonstrate only modest efficacy, achieving abstinence rates of 20-30% while facing challenges such as high relapse rates and poor adherence. The persistent unmet need is exacerbated by the serious complications associated with AUD, including liver disease, cardiovascular issues, and mental health disorders. CMND-100 is positioned as a first-in-class therapy, leveraging a novel MEAI mechanism that distinguishes it from existing opioid antagonists and GABA modulators, with no other drugs sharing this specific mechanism of action. As of May 13, 2026, the development of CMND-100 has progressed beyond the initial Phase I stage into a multinational, FDA-approved Phase I/IIa trial (HIC# 2000035043 at Yale), although no NCT number is listed in the sources. This trial is structured as a four-part study involving both single and multiple doses, enrolling participants aged 18-60, including healthy volunteers and individuals with moderate to severe AUD or binge drinking patterns (BMI 18-35). The trial is being conducted at prestigious sites such as Yale School of Medicine, Johns Hopkins, and IMCA Center in Israel. It features a partially blinded design with a placebo control, focusing on inpatient monitoring over 24 hours. The primary endpoints include safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD), while secondary endpoints assess preliminary efficacy through reductions in drinking patterns and cravings. Enrollment is ongoing, with 18 participants having completed treatment and follow-up. Positive interim data from the third dose cohort indicate high tolerability, no serious adverse events, and favorable safety at higher doses, although full PK/PD or efficacy metrics remain unreported. Currently, CMND-100 does not hold any specific regulatory designations for AUD, such as Fast Track or Breakthrough Therapy status. The safety profile appears robust thus far, with no discontinuations or adverse signals noted. In terms of competitive positioning, CMND-100 stands apart from established AUD treatments and the limited pipeline of alternatives, as there are no direct MEAI competitors. While psychedelic-adjacent programs, such as ibogaine derivatives, encounter regulatory challenges, precedents like nalmefene (approved in the EU for relapse risk) have shown modest efficacy but limited uptake. Recent rejections of suvorexant analogs for addiction due to safety and efficacy concerns further highlight the competitive landscape. Conversely, successes like the repurposing of semaglutide for AUD, which has shown promising Phase II signals, underscore the potential of reward modulation but also emphasize the necessity for robust Phase III data. The estimated probability of approval (PoA) for CMND-100 stands at 12.5%. This figure reflects the progress made in the Phase I/IIa trial, with historical data suggesting a PoA of approximately 10-15% from Phase I in addiction contexts, slightly enhanced by the clean safety profile and novel mechanism of action. However, the small size of the sponsoring biotech, which has no prior FDA approvals and lacks pharmaceutical partnerships, coupled with unproven long-term efficacy and the inherent risks associated with psychedelic compounds, tempers the outlook. While the standard PoA for Phase II to approval is around 30%, the early-stage nature of CMND-100 and execution challenges result in a lower estimate. The investment appeal is contingent on upcoming catalysts, such as the release of full Phase I/IIa data, but the high binary risk associated with this asset suggests it is best suited for speculative portfolios. Read More
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
Searchable FDA calendar providing data readouts and PDUFA
Includes 3 day Elite access 