Capricor shares fall 70% after FDA questions efficacy

Shares of Capricor Therapeutics plummeted as much as 70% on Monday, July 27, 2026, after U.S. Food and Drug Administration staff released critical briefing documents questioning the effectiveness of the company's experimental cell therapy for Duchenne muscular dystrophy. The sharp decline followed the publication of FDA reviewers' concerns ahead of a key advisory committee meeting scheduled for Wednesday, July 29.

The FDA documents raised significant issues with deramiocel, Capricor's investigational treatment for cardiomyopathy associated with Duchenne muscular dystrophy. Agency staff concluded that the therapy did not meet the objectives of its pivotal Phase 3 trial, contradicting the company's announcement last December that the study had met both primary and secondary endpoints. Reviewers highlighted that Capricor changed how it measured the trial's main results after the study ended, switching from analyzing raw scores on a 42-point arm function test to calculating results as a percentage change. The FDA stated this post-hoc modification was not scientifically justified.

Further concerns were outlined in the briefing materials. FDA scientists noted that evidence was limited...