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 Inc. received a complete response letter (CRL) from the U.S. FDA on the BLA for deramiocel to treat cardiomyopathy in Duchenne muscular dystrophy patients. The company’s CEO said ...

Shares of Capricor TherapeuticsCAPR plummeted Friday after the Food and Drug Administration rejected its experimental ...

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

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 multiple cell and gene therapy officials from the agency during deramiocel’s review.

The FDA published a database of letters sent to drugmakers during the review process of medications that provide information on the agency's initial feedback or requirements for more data. These ...

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

The U.S. Food and Drug Administration declined to approve Capricor Therapeutics' cell therapy for a heart condition and asked ...

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 ...