Dive Brief:
Capricor Therapeutics hasn’t definitively proven that its experimental cell therapy benefits people with heart-related complications of Duchenne muscular dystrophy, a Food and Drug Administration panel concluded Wednesday.
Capricor reported last year that its treatment, deramiocel, hit the main goals of a Phase 3 study in Duchenne patients with cardiomyopathy. But FDA scientists expressed skepticism about the data Capricor compiled and, by a 9-3 vote, the advisory panel determined the results didn’t show “substantial evidence” of the therapy’s effectiveness.
The FDA rejected deramiocel last July but agreed to review a revised pitch from Capricor afterwards. The agency typically, though not always, sides with its advisory panels. It’s expected to make a decision on the company’s latest submission by Aug. 22.
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