ARTICLE | Product Development
Capricor’s Phase III data shore up resubmission in DMD cardiomyopathy
Shares jump as late-stage data appear to confirm skeletal, cardiac effects seen in small Phase II study
December 3, 2025 10:44 PM UTC
A new readout for Capricor’s deramiocel builds the case for its approval to treat Duchenne muscular dystrophy, and appears to satisfy FDA’s requirements for a resubmission following a July complete response letter.
Top-line data released Wednesday morning showed deramiocel’s statistically significant effects on both the primary musculoskeletal endpoint and a key secondary endpoint measuring cardiac function in the Phase III HOPE-3 study, which evaluated more than five times as many patients than did the Phase II HOPE-2 trial upon which the company had based its previous BLA submission...