FDA schedules advisory committee meetings for rejected Replimune melanoma drug and Capricor DMD cell therapy

The FDA announced that it will hold two advisory committee meetings this week to revisit investigational therapies that were previously turned down. One meeting will consider Capricor Therapeutics' cell therapy for Duchenne muscular dystrophy‑related cardiomyopathy, while the other will review Replimune's advanced melanoma candidate RP1.

Industry observers expressed surprise at the timing of the meetings after a nine‑month lull in advisory committee activity. Some regulators and company leaders are questioning why the agency has chosen to revisit these particular assets now and whether the committee composition includes the appropriate expertise.

The FDA’s Cellular, Tissue, and Gene Therapies advisory committee (CTGTAC) is slated to convene on July 29 for Capricor’s therapy and on July 30 for Replimune’s drug. The schedule signals a shift in the agency’s approach, but stakeholders remain cautious about the potential outcomes.