Capricor Shares Surge on FDA Review of Duchenne Drug Amendment

Capricor Therapeutics shares surged more than 60 percent on Friday after the company announced the U.S. Food and Drug Administration is willing to review new data for its experimental Duchenne muscular dystrophy drug, deramiocel, potentially extending the regulatory review timeline. The move comes after a sharp stock decline last month when an FDA advisory panel voted against the drug's effectiveness for its originally proposed use.

The company's stock had plummeted on July 27, 2026, after the FDA released briefing documents raising concerns about changes to Capricor's statistical analysis plan. The decline accelerated on July 29 when the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee voted 9-3 against recommending deramiocel for cardiomyopathy associated with Duchenne muscular dystrophy. The panel questioned whether enrolled patients even had Duchenne-related cardiomyopathy, given their normal heart function at baseline, and echoed FDA staff concerns about changes to how the trial's main outcomes were measured.

During the company's second quarter 2026 earnings call on Thursday, CEO Linda Marbán emphasized that cardiomyopathy was a secondary endpoint in the Phase...