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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AAPGAscentage Pharma Group International - American Depository Shares
Olverembatinib combined with lisaftoclax presents a promising investigational regimen for pediatric relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia (R/R Ph+ ALL), a rare yet devastating pediatric malignancy characterized by historically poor outcomes. This combination therapy integrates olverembatinib, a third-generation BCR-ABL1 tyrosine kinase inhibitor effective against resistant mutations such as T315I, with lisaftoclax, a novel BCL-2 inhibitor that targets anti-apoptotic pathways. The development of this dual-mechanism approach is spearheaded by Ascentage Pharma, a Chinese biotech firm with expanding global clinical development capabilities. The global market for pediatric R/R Ph+ ALL is estimated to be between $200-300 million, reflecting the rarity of the disease, with approximately 500-800 new cases reported annually in North America and Europe. This market also underscores a significant unmet medical need, as current standard treatment options, which include intensive chemotherapy, second-generation BCR-ABL1 inhibitors (such as dasatinib and nilotinib), and allogeneic hematopoietic stem cell transplantation, are associated with considerable toxicity and frequent treatment failures. The ability of the olverembatinib and lisaftoclax combination to achieve clinical remission without chemotherapy addresses a critical gap in pediatric oncology. This regimen is classified as "best-in-class" rather than first-in-class, as while individual components exist, their specific combination for this indication offers meaningful differentiation from existing monotherapies. Currently, the program is in Phase 1b development, with compelling early efficacy data presented at ASH 2024. Among six evaluable patients, the combination regimen achieved an 83.3% complete remission (CR) rate and a 71.4% measurable residual disease (MRD) negativity rate, significantly surpassing historical controls for this indication. In contrast, monotherapy with olverembatinib alone yielded a CR rate of only 33.3%, underscoring the synergistic benefits of dual-pathway targeting. The safety profile is notable, with no dose-limiting toxicities reported, no drug-drug interactions between the two agents, and pharmacokinetic characteristics that are comparable between pediatric and adult populations. Adverse events of grade 3 or higher were rare, primarily consisting of isolated cases of grade 2 extremity pain and myopathy. However, the program faces several development challenges. The small Phase 1b cohort (6-7 evaluable patients) necessitates larger Phase 2 trials to confirm efficacy and establish optimal dosing regimens. Currently in the dose-expansion phase, Phase 2 data are anticipated within the next 12-24 months. Additionally, lisaftoclax remains investigational and has not yet received FDA approval; any delays or safety concerns in its development could jeopardize the combination program. Furthermore, the absence of formal regulatory designations such as Fast Track, Breakthrough Therapy, or Orphan Drug for this specific indication may indicate that the FDA does not yet prioritize this program, despite its clinical promise. Comparable precedents in the field provide mixed signals. Drugs like ponatinib and dasatinib were approved for Ph+ leukemias based on Phase 1/2 data demonstrating efficacy in resistant disease, suggesting the potential for approval based on early-stage data. However, venetoclax-based regimens have achieved similar CR rates (75-80%) in pediatric R/R ALL, which may limit differentiation in the market. The regulatory pathway is expected to involve a standard NDA/BLA submission following Phase 2 data, with potential for accelerated pathways (such as Breakthrough Therapy or Orphan Drug designation) if the Phase 2 results confirm the efficacy observed in Phase 1b and if formal requests for designation are submitted. The estimated probability of approval stands at 62-72% (midpoint: 67%). This assessment reflects the compelling Phase 1b efficacy and safety data, the critical unmet medical need in this pediatric rare disease, and favorable regulatory precedents for therapies targeting Ph+ leukemia. Nevertheless, risks remain, including the small sample size, early development stage, lack of regulatory designations, and the complexity of requiring simultaneous approval of two investigational drugs. Key upcoming catalysts include the anticipated Phase 2 data readout, presentations at ASH 2025 or EHA 2025, and potential regulatory designation requests. Long-term toxicity signals, challenges in Phase 2 enrollment, and competitive pressure from venetoclax-based regimens represent significant downside risks. For investors, this program offers a high-risk, high-reward opportunity in a rare pediatric indication with substantial unmet need, though approval is not guaranteed without successful Phase 2 data and ongoing commitment from the sponsor to advance development. Read More
Lisaftoclax (APG-2575) Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) treated with Lisaftoclax in a pivotal Phase 2 study
Phase 2
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Lisaftoclax (APG-2575), developed by Ascentage Pharma, is an oral small-molecule BCL-2 inhibitor aimed at restoring apoptosis in cancer cells. This drug represents the second BCL-2 inhibitor class globally and is the first approved in China for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Lisaftoclax has undergone extensive clinical evaluation, including pivotal Phase 2 studies targeting relapsed/refractory CLL/SLL populations. The global CLL/SLL treatment market is projected to reach $4.5–6.2 billion between 2024 and 2025, with a significant unmet medical need in relapsed/refractory cases, particularly among patients resistant to Bruton's tyrosine kinase (BTK) inhibitors or those with prior venetoclax exposure. Current treatment options include venetoclax (Venclexta®), BTK inhibitors (such as acalabrutinib, ibrutinib, and zanubrutinib), and anti-CD20 monoclonal antibodies. Lisaftoclax addresses a critical treatment gap by providing an alternative BCL-2 inhibitor with a favorable safety profile and demonstrated efficacy in venetoclax-resistant populations, achieving an 86% overall response rate when combined with acalabrutinib. Classified as best-in-class, lisaftoclax differentiates itself from venetoclax, which was approved in 2016. Key differentiators include improved tolerability with minimal tumor lysis syndrome, a patient-friendly five-day ramp-up dosing schedule, and demonstrated efficacy in venetoclax-resistant patients. These attributes position lisaftoclax as a potentially superior option within the BCL-2 inhibitor class. As of May 2026, lisaftoclax has transitioned from Phase 2 to Phase 3 development. The pivotal Phase 2 trial (APG2575CC201, NCT05147467) evaluated monotherapy in relapsed/refractory CLL/SLL and successfully met its primary endpoint of overall response rate. The Phase 1/2 trial (NCT04215809) enrolled 176 patients across three arms, including monotherapy and combination regimens, demonstrating robust efficacy, particularly in combination therapies. The initiation of Phase 3 trials was announced in August 2023 following FDA IND clearance. The pivotal Phase 2 study employed a single-arm design, with overall response rate as the primary endpoint, assessing lisaftoclax monotherapy in patients with prior BTK inhibitor and/or chemoimmunotherapy exposure. The Phase 1/2 trial was more comprehensive, stratifying patients by treatment history and evaluating combination regimens. Specific details regarding the Phase 3 trial design, including randomization and comparator selection, remain undisclosed. Efficacy results from the Phase 2 trial indicate that monotherapy met the primary endpoint in relapsed/refractory CLL/SLL patients with prior BTK inhibitor exposure. Combination therapy data are particularly compelling; the combination of lisaftoclax and acalabrutinib achieved a 96% overall response rate, with 100% response in treatment-naïve patients and 98% in relapsed/refractory patients. Notably, patients with prior venetoclax exposure demonstrated an 86% overall response rate with the combination, suggesting significant potential in resistant populations. Lisaftoclax exhibits an excellent safety profile, with no cases of tumor lysis syndrome reported in monotherapy trials and extremely low incidence in combination regimens. Adverse event rates for both hematologic and non-hematologic toxicities were low, and the five-day ramp-up schedule proved feasible with close monitoring, offering a patient-friendly alternative to standard venetoclax dosing. In terms of regulatory designations, lisaftoclax received NMPA approval in China on July 10, 2025, for adult patients with CLL/SLL who have undergone at least one prior systemic therapy, including BTK inhibitors. This approval marks the first BCL-2 inhibitor authorized in China for this indication and the second globally. The drug was included in the 2025 Chinese Society of Clinical Oncology (CSCO) Guidelines. In the United States, the drug received FDA IND clearance for Phase 3 trials in August 2023, but has not yet secured Fast Track, Breakthrough Therapy, or Orphan Drug designations for this indication. The competitive landscape includes venetoclax, which remains the market-leading BCL-2 inhibitor with established efficacy and safety data. However, concerns regarding venetoclax's long-term tolerability and resistance mechanisms create opportunities for differentiated agents like lisaftoclax. Emerging competitors, including bispecific antibodies and CAR-T therapies, may further fragment the market. Lisaftoclax's potential for combination therapy synergy with next-generation BTK inhibitors, particularly acalabrutinib, provides a competitive edge. The estimated probability of approval for lisaftoclax stands at 72-78%. This estimate reflects several supporting factors, including strong Phase 2 efficacy, an excellent safety profile, and the validated BCL-2 mechanism evidenced by venetoclax's success. The unmet medical need in relapsed/refractory and venetoclax-resistant populations further supports this outlook. However, mitigating factors include the uncertainty surrounding the Phase 3 trial's outcomes, the entrenched position of venetoclax as standard-of-care, and potential regulatory hurdles in the U.S. Investors should closely monitor the initiation and progress of the Phase 3 trial, as well as any interim efficacy readouts, as these will be critical decision points for the investment thesis surrounding lisaftoclax. Read More
Setmelanotide (IMCIVREE) is a melanocortin-4 receptor (MC4R) agonist that has emerged as the first targeted therapy for acquired hypothalamic obesity, particularly in patients who have undergone prior bariatric surgery, provided they meet the criteria for the acquired hypothalamic obesity population. A significant update in the drug's development status is that it is no longer in Phase 3; the FDA has approved IMCIVREE for acquired hypothalamic obesity in both adults and pediatric patients aged four and older, based on Phase 3 data and a supplemental NDA review. Consequently, the development phase for this indication is now classified as approved/commercialized rather than late-stage investigational. The estimated probability of approval (PoA) for Setmelanotide stands at 98.0%. This high PoA reflects the robust clinical data supporting the drug's efficacy and safety profile. From a market perspective, the global market size for acquired hypothalamic obesity is estimated to be between $0.1 billion and $0.3 billion. There is a significant unmet need in this area, as acquired hypothalamic obesity is a rare, severe, and challenging condition to treat, primarily driven by hypothalamic injury and dysregulated hunger and weight gain. The available evidence indicates that IMCIVREE is the first and only treatment specifically targeting this pathway for the condition, reinforcing its first-in-class classification. While the indication is now approved, key risks remain. The primary concern is not the failure of approval but rather the post-launch uptake, reimbursement, and real-world tolerability of the drug. Safety and tolerability are critical factors, as Phase 2 data reported common adverse events including nausea, vomiting, hyperpigmentation, and diarrhea. Long-term treatment persistence will also be a crucial consideration. Furthermore, the evidence base for the specific subgroup of participants with prior bariatric surgery appears limited, which raises the risk of extrapolation if this subgroup differs materially from the broader acquired hypothalamic obesity population. Upcoming catalysts include updates on post-marketing adoption and real-world utilization, although specific timing has not been disclosed. Additionally, decisions regarding payer coverage and formulary inclusion are anticipated, along with further subgroup or long-term extension data in acquired hypothalamic obesity. Setmelanotide is administered as a prescription subcutaneous daily peptide that activates the MC4R pathway, which plays a vital role in hunger and weight regulation. Rhythm’s product materials emphasize that IMCIVREE is the “first and only” therapy targeting impaired MC4R signaling in acquired hypothalamic obesity, Bardet-Biedl syndrome, and certain genetic obesity disorders. The pivotal evidence supporting its approval includes a Phase 2, open-label, multicenter trial (NCT04725240) involving patients aged 6 to 40 years over a 16-week treatment period. The primary endpoint assessed the proportion of patients achieving at least a 5% reduction in BMI at 16 weeks compared to a historical control rate of less than 5%. Although detailed Phase 3 protocol information and efficacy tables are not publicly available, it is confirmed that FDA approval was granted based on Phase 3 data. The safety profile of Setmelanotide aligns with previous experiences, with nausea (61%), vomiting (33%), skin hyperpigmentation (33%), and diarrhea (22%) reported as frequent adverse events in the acquired hypothalamic obesity study. No major new safety signals have been identified in the available sources. Regulatory exclusivity and designations for this specific indication have not been verified, leading to a classification of false/negative for fast track, orphan, breakthrough, priority review, or accelerated approval designations. The competitive landscape appears favorable, as there are no approved direct competitors for this indication, further supporting its first-in-class classification. Rhythm’s track record in securing approvals in this niche is commendable, with IMCIVREE being an established product that has successfully expanded its label to include acquired hypothalamic obesity. Historical precedents in rare obesity drug development demonstrate that single-mechanism, biomarker-defined approvals, where efficacy and tolerability are critical, have been successful. In this case, the approval of IMCIVREE serves as a clear precedent, with biologic plausibility, demonstrated weight-loss benefits, and the absence of alternatives being decisive factors in its approval. Read More
Oral deucrictibant is Pharvaris’s investigational, orally administered bradykinin B2 receptor antagonist being developed for both prophylaxis and on-demand use in hereditary angioedema (HAE). The prophylaxis program has progressed beyond Phase 2, with the key placebo-controlled Phase 2 study, CHAPTER-1 (NCT05047185), now complete. Pharvaris is currently conducting the pivotal Phase 3 CHAPTER-3 (NCT06669754) study, which targets adolescents and adults with HAE. This global, multicenter, randomized, double-blind, placebo-controlled trial evaluates once-daily oral deucrictibant XR 40 mg for the prevention of attacks. The Phase 2 study enrolled 34 patients who were randomized to receive deucrictibant at doses of 20 mg, 40 mg, or placebo. The primary endpoint was the monthly attack rate, and the results demonstrated a statistically significant reduction compared to placebo, with rates of 0.40 attacks/month for the 20 mg dose and 0.30 for the 40 mg dose versus 1.93 for placebo, corresponding to reductions of 79.2% and 84.5%, respectively, with p-values of 0.0010 and 0.0008. Safety data from the trial were encouraging, revealing that treatment-related adverse events were mild, occurring in 18% and 8% of active-dose patients compared to 9% in the placebo group, with no serious adverse events or deaths reported. Deucrictibant represents a first-in-class mechanism for HAE prophylaxis, as it is a selective B2 receptor antagonist. The publication explicitly states that this trial provides the first clinical evidence supporting bradykinin B2 receptor antagonism for the prevention of HAE attacks. However, the commercial opportunity exists within a crowded prophylaxis market that includes established injected and oral options, raising the bar for differentiation. Despite multiple approved prophylactic options, there remains a significant unmet need, as many HAE patients continue to seek improved oral convenience, sustained attack control, and enhanced tolerability, indicating that long-term prophylaxis is still an active area of demand. In terms of regulatory designations specific to prophylaxis in HAE, the available sources do not indicate any Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval status for this indication. Consequently, these designations have been marked as false or unknown where applicable. Pharvaris has a positive development track record in HAE, having advanced both prophylaxis and on-demand programs into late-stage development, with no prior FDA approval or rejection history indicated for this company in this context. The key risks associated with deucrictibant include execution risk in Phase 3, as the program's success hinges on confirming the efficacy and safety observed in Phase 2 within larger, more diverse populations. Additionally, competitive differentiation is a concern, as existing prophylaxis options necessitate that deucrictibant demonstrates clear advantages in attack reduction, tolerability, and oral convenience to achieve meaningful market uptake. Regulatory scrutiny is also anticipated, particularly regarding attack-rate endpoints, durability, and safety in a chronic preventive setting, given the need for a robust benefit-risk profile. Looking ahead, upcoming catalysts include the readout from the CHAPTER-3 Phase 3 prophylaxis trial, with timing not disclosed, as well as potential regulatory interactions and updates enabling the New Drug Application (NDA), also with timing not disclosed. Overall, while the Phase 2 signal is strong and the safety profile is favorable, the probability of approval is moderated by uncertainties in Phase 3 and the necessity to establish a meaningful advantage in a competitive chronic prevention market. A probability of approval (PoA) of 68.0% is deemed reasonable for a well-designed, late-stage rare-disease prophylaxis program with positive randomized Phase 2 data and ongoing pivotal testing, contingent on the CHAPTER-3 trial confirming efficacy and tolerability at scale. Read More
Olverembatinib (HQP1351), developed by Ascentage Pharma (AAPG), is an oral third-generation BCR-ABL1 tyrosine kinase inhibitor (TKI) designed to address the challenges of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This aggressive subtype comprises 25-50% of adult ALL cases and is characterized by high relapse rates and poor long-term survival outcomes. Current treatment regimens, which typically combine TKIs with intensive chemotherapy, yield complete response (CR) rates exceeding 80%. However, these approaches still result in relapse rates of 50-70% and a five-year overall survival (OS) rate of approximately 40-50%. The global market for Ph+ ALL therapies is estimated to reach $1.2 billion at peak sales, driven by an annual incidence of approximately 5,000-7,000 new cases in the US, EU, and Japan. Despite the presence of existing treatments, a significant unmet need remains, particularly for adults who are unfit for intensive chemotherapy or allogeneic hematopoietic stem cell transplantation (allo-HSCT). Olverembatinib, when combined with low-intensity chemotherapy, is positioned as a best-in-class therapy, offering a differentiated profile due to its third-generation mechanism and chemotherapy-sparing potential. Phase 2 data indicate a complete molecular response (CMR) rate of 62% at three months when combined with venetoclax, and over 90% CMR in combinations with blinatumomab, which contrasts with the shallower responses seen with ponatinib. Currently, olverembatinib is in Phase 3 development, with the POLARIS-1 trial (NCT06051409) evaluating its efficacy against standard TKI plus chemotherapy. This global, randomized, multicenter study aims to determine whether olverembatinib combined with low-intensity chemotherapy can achieve superior CMR rates at three months, with secondary endpoints including OS and event-free survival (EFS). While topline results are expected after the 2024 ASH presentation, preliminary Phase 2 data from a cohort of 79 adults showed a CMR of 62%, a one-year OS of 93.1%, and an EFS of 89.1%, with no induction-related deaths reported. Safety profiles appear manageable, with common adverse events being grade 1 or 2, including thrombocytopenia and hyperpigmentation, alongside a low discontinuation rate. Regulatory designations for olverembatinib include Orphan Drug Designation for Ph+ leukemia, which enhances exclusivity, though it lacks Fast Track or Breakthrough Therapy Designation for newly diagnosed Ph+ ALL. The competitive landscape features established therapies such as ponatinib and emerging options like asciminib, as well as potential threats from chemotherapy-free regimens combining blinatumomab and venetoclax. Ascentage Pharma has a solid track record, having secured approval for olverembatinib in China for T315I chronic myeloid leukemia (CML) in 2021, and is pursuing global expansion through partnerships, including one with Johnson & Johnson for commercialization efforts. The estimated probability of approval for olverembatinib stands at 72.5%, reflecting the historical success rate for oncology Phase 3 trials, coupled with the promising efficacy and safety data from Phase 2 studies. Key risks include the potential failure of the Phase 3 trial to demonstrate superior CMR or OS compared to standard therapies, safety concerns leading to dose limitations, and increasing competition from alternative treatment regimens. Upcoming catalysts include topline data from the POLARIS-1 trial and potential FDA filing, which could significantly impact the market positioning of olverembatinib. Overall, olverembatinib represents a compelling investment opportunity in the high-need Ph+ ALL space, with significant upside potential if it can demonstrate improved outcomes compared to existing therapies. Read More
Budoprutug is Climb Bio’s anti-CD19 monoclonal antibody, designed to deplete B cells through antibody-dependent cellular cytotoxicity. This innovative, first-in-class approach targets immune thrombocytopenia (ITP) and distinguishes itself from existing therapies. The current public evidence indicates that the ITP program is undergoing an open-label, sequential-cohort Phase 1b/2a dose-escalation and expansion study involving adults with platelet counts below 30,000/µL despite prior treatments. While the study is reported to be enrolling participants, there is no indication as of the analysis date that it has progressed beyond Phase 1b/2a. The trial involves two intravenous infusions spaced 14 days apart, with endpoints focused on safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy. However, the absence of a randomized, placebo-controlled, or blinded design limits the interpretability of early results and leaves efficacy uncertain. Currently, no peer-reviewed efficacy results, response rates, hazard ratios, or duration metrics have been disclosed for the ITP program. Safety data specific to the ITP cohort are also not available, raising questions about tolerability. Mechanistically, CD19 depletion is compelling, as B cells play a significant role in autoantibody production and immune dysregulation in ITP. However, this strategy may be broader and potentially more immunosuppressive than many standard-of-care agents. In the competitive landscape, budoprutug will face established therapies such as corticosteroids, IVIG, rituximab, TPO receptor agonists, fostamatinib, and newer immune-modulating agents in development. The differentiation bar is set high; budoprutug must demonstrate rapid platelet improvement, durable responses, and an acceptable safety profile regarding infections and immunoglobulin levels. Market analysis reveals that the global market for ITP is valued at $3.0 billion, with a significant unmet need. Primary ITP is a chronic relapsing autoimmune disorder that requires durable platelet responses, steroid-sparing options, and therapies that minimize long-term immunosuppression or splenectomy. Current treatment options often exhibit limited durability, variable response rates, and tolerability issues. Budoprutug's classification as a first-in-class therapy positions it uniquely within this market. Regarding regulatory designations, budoprutug does not currently hold Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval status for primary ITP. It is crucial to note that designations granted for other indications, such as primary membranous nephropathy, do not apply to ITP. Climb Bio is a relatively new clinical-stage company without prior FDA approval history, which introduces execution risks, although this alone does not disqualify the drug's potential. The estimated probability of approval (PoA) for budoprutug stands at 17.5%. This figure is informed by standard phase-adjusted biotechnology probabilities, which typically assign a low-to-mid teens PoA to Phase 1b/2a antibody programs in competitive autoimmune indications until significant human efficacy is demonstrated. Budoprutug’s PoA benefits from a biologically plausible mechanism and growing interest in B-cell depletion, but it is tempered by early-stage uncertainties, the absence of blinded or randomized data, and no current efficacy readout in ITP. Historical precedents in ITP indicate that even promising immune-targeting approaches can fail in later stages or yield modest, non-durable responses. The upcoming data release in June 2026 will be a critical value-inflection point for the program. Read More
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