Shares of Capricor Therapeutics, Inc. plunged over 30% in intraday trading on Friday, July 11, 2025, after the U.S. Food and Drug Administration rejected the company’s Biologics License Application ...

Capricor Therapeutics plummeted Friday after the FDA rejected its experimental treatment for cardiomyopathy associated with ...

The company said it was optimistic that the issues identified by the Food and Drug Administration could be resolved with new data.

Capricor Therapeutics Inc. said it has received a complete response letter from the U.S. FDA on the BLA for deramiocel to treat cardiomyopathy in Duchenne muscular dystrophy patients. The BLA has a ...

Capricor Therapeutics is expected to release data from the phase 3 HOPE-3 trial in Q3'25, thus presenting a potential path ...

US biotech Capricor Therapeutics today revealed receipt of a Complete Response Letter (CRL) from the US Food and Drug ...

The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the ...

The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy (DMD) cell therapy, raising ...

In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy ...

Happy Friday. Today, we talk about the stem cell fire sale at CIRM, and about the FDA’s move to release a limited batch of ...

Frequency Electronics reported earnings of 34 cents per share for the fourth quarter, up from 28 cents per share in the ...

The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment ...