FDA Calendar: Upcoming PDUFA Dates and Drug Approval Decisions

The FDA calendar for Q4 2026 is packed with five major PDUFA dates. BioXcel Therapeutics' IGALMI stands out with a decision due on November 14, 2026, a crucial moment for the company and its investors.

The full Q3 2026 FDA calendar and PDUFA dates

BTAI's IGALMI®: A First-in-Class Solution for Acute Agitation

IGALMI® (dexmedetomidine), from BioXcel Therapeutics (BTAI), aims to treat acute agitation in bipolar disorders and schizophrenia. Its PDUFA date is November 14, 2026, with a 10% probability of approval (PoA), marking it as a long shot. Initially approved by the FDA in April 2022, it's the sole sublingual film for these conditions, addressing an unmet need. Traditional treatments like benzodiazepines are invasive with significant side effects, making IGALMI a promising non-invasive alternative. The current decision involves a supplemental NDA possibly for Alzheimer's-related agitation, causing some ambiguity about its target. The TRANQUILITY II trial showed positive results, with significant reductions in agitation scores two hours after administration. Common side effects include mild somnolence and dizziness, but concerns about QT interval prolongation and bradycardia persist, particularly in vulnerable groups. The market potential is substantial, but the low PoA and the FDA's pending decision introduce uncertainty.

CAPR's Deramiocel: Navigating the DMD Landscape

Deramiocel (CAP-1002) by Capricor Therapeutics (CAPR) is under FDA review for Duchenne muscular dystrophy (DMD), slated for a November 22, 2026 PDUFA date. This allogeneic cell therapy targets cardiomyopathy linked to DMD, with a moderate 42% probability of approval. The DMD treatment market is projected to hit $3.8 billion by 2026, highlighting its commercial potential. The pivotal HOPE-3 trial supports the Biologics License Application (BLA), but questions linger over the statistical evidence for efficacy. Safety data seems manageable, but advisory committee doubts about the efficacy data's strength introduce uncertainty. Its mechanism, using cardiosphere-derived cells, differentiates it from traditional methods, yet mixed efficacy data poses risks. The high unmet need in DMD treatment makes the PDUFA decision crucial for Deramiocel's future and Capricor's market position.

INO's INO-3107: A Promising Approach for RRP

INO-3107, an investigational DNA immunotherapy by INOVIO Pharmaceuticals (INO), targets recurrent respiratory papillomatosis (RRP) with an FDA decision expected on October 30, 2026. The approval probability is high at 70% due to its first-in-class status. RRP, caused by HPV, has mostly relied on surgery, making INO-3107's approach particularly appealing. The Phase 1/2 trial showed an 81.3% reduction in surgeries post-treatment, with a good safety profile. However, Papzimeos' recent approval presents new challenges for INO-3107 despite its unique DNA platform. This decision could mark the first approval of a DNA medicine in this area, potentially changing the RRP treatment landscape.

TLSA's Foralumab: Early Insights into MS Treatment

Foralumab, an intranasal anti-CD3 monoclonal antibody from Tiziana Life Sciences (TLSA), is being tested for non-active secondary progressive multiple sclerosis (na-SPMS), with results expected in October 2026. The approval probability is low at 20% due to the early-stage trial. Preliminary data from a patient cohort showed stabilization in EDSS scores and reduced fatigue, but defining clinical endpoints remains a challenge. The lack of prior Phase 3 data complicates the approval process. Foralumab's unique delivery method could offer advantages in the evolving MS treatment field; however, the absence of established efficacy metrics and regulatory designations raises concerns. Investors should watch the upcoming results closely as they will impact Foralumab's therapeutic potential and market viability.

GRI's GRI-0621: Addressing IPF with Novel Mechanism

GRI-0621 from GRI Bio is a selective agonist targeting idiopathic pulmonary fibrosis (IPF) and is in Phase 2a trials. The probability of approval is low at 24%, reflecting early-stage challenges and a small sample size. The IPF market is projected to grow to $6.2 billion, emphasizing the need for effective treatments. GRI-0621's mechanism focuses on immune modulation rather than just slowing disease progression, differing from existing antifibrotics. Preliminary data indicated safety and tolerability, but the lack of definitive clinical endpoint data raises approval concerns. The competitive landscape is tough, with current therapies dominating. The results will be key in determining GRI-0621's future and the company's ability to succeed in IPF treatment.

The bottom line

With these critical PDUFA dates approaching, investors should stay alert and consider how each decision will impact the future of these companies.