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 976. Click On The Tickers For More Details
Century Therapeutics (NASDAQ: IPSC) is advancing CNTY-813, its lead program targeting type 1 diabetes (T1D) through an innovative allogeneic induced pluripotent stem cell (iPSC)-derived beta islet cell therapy. Utilizing the proprietary Allo-Evasion 5.0 technology, CNTY-813 aims to facilitate durable insulin production and glycemic control without the need for systemic immunosuppression, thereby positioning itself as a potentially curative option in a therapeutic landscape that has primarily focused on symptomatic insulin management. The T1D market is significant, with an estimated global market size of $15 billion for insulin and related therapies as of 2024. This market is driven by approximately 8-10 million patients worldwide who require lifelong daily insulin injections, facing risks of hypoglycemia and complications such as neuropathy and retinopathy. The unmet need in this area is acute, as no approved therapies currently restore endogenous insulin production without immunosuppression. CNTY-813 is classified as first-in-class, offering a novel hypoimmunogenic iPSC islet approach that stands apart from existing treatments, including standard insulins like Humalog and insulin pumps, as well as near-term competitors. As of May 14, 2026, CNTY-813 remains in pre-clinical development, with no clinical trials initiated and no NCT numbers or enrollment data available. The anticipated IND submission is set for 2026, with initial Phase 1 clinical data expected in 2027, according to the company's financing announcement. Details regarding trial design, endpoints, and safety profiles have not yet been disclosed. Notably, CNTY-813 has not received any regulatory designations for T1D, including Fast Track, Orphan Drug, or Breakthrough Therapy designations. The competitive landscape for CNTY-813 includes Vertex's zimislecel (formerly VX-880), which is currently in Phase 3 and requires immunosuppression, as well as pre-clinical efforts from ViaCyte/Sandoz. There are currently no direct approved rivals for curative cell therapies in this space. Century Therapeutics has not yet achieved any FDA approvals, having previously focused on iPSC platforms, and its prior oncology assets encountered setbacks. However, the pivot to T1D leverages advancements in Allo-Evasion technology. Notably, there are no partnerships currently associated with this program. Precedents in the field inform the estimated probability of approval (PoA) for CNTY-813, which is set at 18-25%. Vertex's VX-880 has demonstrated proof-of-concept for insulin independence in a small Phase 1/2 trial, though it requires immunosuppression, underscoring the value and risk associated with immune evasion technology. Historical challenges with Sernova's Cell Pouch and islet transplants, which have shown limited durability, highlight the typical pre-clinical to approval odds for cell therapies in T1D and autoimmunity, generally ranging from 10-20%. The PoA for CNTY-813 reflects strong financing and execution signals that mitigate some modality risks, despite the absence of human data and Century's unproven status. Key risks associated with CNTY-813 include high technical challenges related to iPSC-derived islet engraftment, vascularization, and long-term function in humans. Additionally, there are concerns regarding potential immune evasion failures leading to rejection, manufacturing scalability, and consistency of potency for allogeneic cell therapy at a commercial scale. Upcoming catalysts include the IND submission in 2026 and initial Phase 1 clinical data in 2027. The investment thesis for CNTY-813 presents a high-risk, high-reward opportunity for a breakthrough in T1D treatment, warranting close monitoring of preclinical updates. Read More
Aleniglipron, developed by Structure Therapeutics (GPCR), is a once-daily oral small-molecule glucagon-like peptide-1 receptor agonist (GLP-1RA) aimed at treating obesity. As a non-peptide mimetic, it provides a pill alternative to established injectable therapies such as Wegovy (semaglutide) and Zepbound (tirzepatide), catering to patient preferences for oral administration amid growing injection fatigue. The obesity market is substantial, projected to reach $150 billion globally by 2030, driven by increasing prevalence and demand for pharmacological interventions. There is a significant unmet need, as current injectable therapies leave approximately 30-40% of patients non-adherent due to needle aversion, while oral options remain limited. Aleniglipron is positioned as a best-in-class oral treatment, claiming "injectable-like efficacy" with a reported 16.3% placebo-adjusted weight loss (39 lbs) at a 180mg dose over 44 weeks, surpassing Lilly's orforglipron, which achieved an 11% weight loss at 72 weeks. Currently, aleniglipron is in the post-Phase 2 development stage, with no further advancements reported as of May 2026. Key trials include ACCESS II (NCT06693843, Phase IIb) and the ACCESS open-label extension (OLE). ACCESS II was a randomized, double-blind, placebo-controlled study involving approximately 85 overweight and obese adults, with the primary endpoint focused on placebo-adjusted weight loss at 44 weeks and secondary endpoints assessing safety and tolerability. The efficacy results were promising, showing weight loss of 16.3% (180mg, p<0.0001), 16.0% (240mg, p<0.0001), and 14.7% (lower dose), with no evidence of a plateau. The OLE demonstrated sustained efficacy, with a continued weight loss of 16.2% (40.5 lbs) at a 120mg dose over 56 weeks. Safety profiles were consistent with the GLP-1 class, with gastrointestinal adverse events (AEs) being predominant, including nausea and vomiting. However, discontinuation rates raised concerns, with an overall rate of 3.4% (median follow-up of 20 weeks), 10.4% in the Phase IIb trial, and 27.9% during titration, which involved a suboptimal 5mg starting dose. No severe cardiac events were reported. Aleniglipron does not currently hold any regulatory designations for obesity, such as Fast Track or Breakthrough Therapy status. The competitive landscape is intense, with approved injectables like semaglutide (15-20% weight loss) and tirzepatide (20-22% weight loss) setting high benchmarks. Orforglipron, an oral competitor with Phase 3 trials completed and imminent approval, shows a weight loss of 11-14%, trailing behind aleniglipron's Phase 2 results but benefiting from a more mature data profile. Other pipeline oral therapies, such as Novo's amycretin, are still lagging in data. The estimated probability of approval (PoA) for aleniglipron stands at 52.5%. This figure reflects strong Phase 2 efficacy, positioning aleniglipron among the top oral therapies with efficacy comparable to injectables, and is supported by consistent results across multiple trials. Historical data suggests a Phase 2-to-approval probability of approximately 45-55% for obesity treatments and GLP-1s. The lack of a plateau in efficacy and relatively low baseline discontinuation rates compared to competitors bolster this PoA, although concerns remain regarding the sponsor's novelty, as Structure Therapeutics has no prior approvals and lacks partnerships with major pharmaceutical companies. The risks include potential increases in adverse events and gaps in long-term efficacy data. Upcoming catalysts include an FDA meeting scheduled for Q2 2026 and the initiation of Phase 3 trials in the second half of 2026. The bullish case suggests that aleniglipron could disrupt the $150 billion obesity market as a best-in-class oral treatment, while the bearish case highlights the risk of eroded differentiation against generics and injectables. This presents a high-reward binary opportunity for GPCR shareholders. Read More
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
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
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