FDA extended review timelines for Capricor Therapeutics’ deramiocel, delaying the PDUFA decision as the agency requests additional data for a more focused indication. The update follows earlier controversy around deramiocel’s development path in Duchenne muscular dystrophy. Capricor says the FDA pushed back its decision date to review refined information tied to a niche use-case rather than the broader initial framing. For investors and clinicians, the new timeline keeps the debate alive around evidentiary thresholds for cell-based therapies while preserving the company’s opportunity to re-argue clinical benefit within the updated parameters.