By Colin Kellaher

Capricor Therapeutics shares plummeted in premarket trading Friday after the U.S. Food and Drug Administration turned away the biotechnology company's bid for approval of Deramiocel, its lead cell-therapy candidate.

Capricor, which was seeking approval of Deramiocel for treatment of cardiomyopathy associated with the neuromuscular genetic disease Duchenne muscular dystrophy, or DMD, said the FDA determined that the company's application didn't meet the statutory requirement for substantial evidence of effectiveness, and that the agency needed more clinical data.

Shares of the San Diego company, which closed Thursday at $11.40, were recently down 50% to $5.70 in premarket trading.

Capricor said it was surprised by the FDA's decision, and that it plans to meet with the agency to determine its next steps, adding that it is committed to getting Deramiocel through the approval process.

DMD is a severe genetic disorder characterized by progressive muscle degeneration that affects the skeletal, respiratory and cardiac muscles. Over time, deterioration of the heart muscle leads to cardiomyopathy and heart failure, which is the leading cause of death in DMD.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

July 11, 2025 07:24 ET (11:24 GMT)

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