FDA Calendar: Upcoming PDUFA Dates and Drug Approval Decisions

The FDA calendar for 2026 is filled with significant decision dates. The August 22 deadline for CAPR's Deramiocel (CAP-1002) stands out, with a 77% chance of approval. Understanding these upcoming FDA approvals is crucial for investors and the biopharma landscape.

The full Q3 2026 FDA calendar and PDUFA dates

CAPR's Deramiocel: A Potential Breakthrough for Duchenne Muscular Dystrophy

Deramiocel (CAP-1002) from Capricor Therapeutics faces an FDA decision on August 22, 2026, with a 77% chance of approval. This first-in-class allogeneic cell therapy targets Duchenne muscular dystrophy (DMD), addressing both skeletal muscle weakness and cardiac issues. This approach marks a shift from current therapies focusing mainly on skeletal symptoms. The Phase 3 HOPE-3 trial included 106 boys and met its primary endpoint, showing a significant improvement in upper limb function. However, the FDA had previously issued a Complete Response Letter, indicating unresolved concerns. The market for DMD treatments is large, but competition is tough. Investors should watch the FDA's evaluation, as the drug’s dual-target mechanism may change DMD treatment standards.

MPLT's ML-007C-MA: A New Hope for Schizophrenia?

MapLight Therapeutics is hopeful about ML-007C-MA, a novel combination therapy for schizophrenia. Top-line results from the ZEPHYR Phase 2 study are expected by August 31, 2026. Despite its innovative formulation, combining an M1/M4 muscarinic agonist and a peripheral anticholinergic, the drug only has a 23% chance of approval. The schizophrenia market, valued at around $15 billion, presents a huge opportunity. However, ML-007C-MA must prove more effective than recent therapies like COBENFY. The lack of regulatory designations adds to its uncertainty. Investors should consider the high risk, as ML-007C-MA must outperform existing treatments in efficacy and safety to secure FDA approval.

ML-004: A Risky Venture in Autism Spectrum Disorder

Another MapLight project, ML-004, targets autism spectrum disorder (ASD) but has just a 4% chance of approval. Recent Phase 2 trial results were disappointing, as the drug failed to improve core social communication deficits. While the ASD market could reach $15.2 billion, current treatments mainly address associated symptoms, leaving a significant unmet need. Despite its first-in-class status, ML-004 did not show efficacy in key symptoms, a crucial factor for FDA approval. Investors should be extremely cautious, given the high likelihood of program termination after failing to meet endpoints.

Tiziana Life Sciences: Foralumab's Challenge in Multiple Sclerosis

Foralumab, an intranasal anti-CD3 monoclonal antibody from Tiziana Life Sciences, is in a Phase 2a trial for non-active secondary progressive multiple sclerosis (na-SPMS), with results due in October 2026. Its approval probability is 20%, reflecting the complexities of treating na-SPMS. Early data suggest stabilization in disability scores, but the lack of pivotal efficacy data is concerning for market viability. Historically, success rates for biologics in neurology are around 15-25%. Investors should be aware of high placebo response risks and the absence of prior Phase 3 data, which could impede approval.

INO-3107: A Potential Shift for Recurrent Respiratory Papillomatosis

INO-3107 from INOVIO Pharmaceuticals awaits an FDA decision on October 30, 2026, with a 70% chance of approval. Targeting recurrent respiratory papillomatosis (RRP), INO-3107 moves away from surgical interventions, addressing a significant unmet need in this rare disease. The drug’s Phase 1/2 trial showed an 81.3% reduction in surgeries post-treatment. However, competition from new therapies like Papzimeos is a challenge, emphasizing the need for INO-3107 to show long-term efficacy. Investors should watch for FDA scrutiny of its efficacy data and its potential to capture the RRP market.

Salarius Pharmaceuticals: The Uncertain Future of the Pan-coronavirus Antiviral

Salarius Pharmaceuticals' pan-coronavirus antiviral is still in preclinical stages, with an IND application expected by November 2026. The approval probability is a low 5%, aligning with historical benchmarks for pre-IND antiviral candidates. With no clinical trials underway and limited data, the path to market is uncertain. The lack of accelerated regulatory designations and the hurdles in developing a novel antiviral for pandemic preparedness add complexity. The weak clinical foundation raises significant doubts about the program’s viability in the competitive antiviral field.

The bottom line

Investors should stay informed and ready to act as these pivotal FDA decision dates approach.