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 has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy (DMD) cell therapy, raising questions about whether the agency's new leadership may be rowing back from ...

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 ...

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 ...

Levi Strauss & Co. (NYSE: LEVI) stock rose as Q2 results beat expectations and full-year guidance was raised. Other gainers ...

Capricor Therapeutics Inc. shares plunged more than 60% after US regulators rejected the company’s treatment for a deadly ...

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 ...

Capricor Therapeutics (CAPR) shares fell Friday after the company announced it received a complete response letter from the FDA for its Biologics License Application for Deramiocel.

Investing.com -- Capricor Therapeutics (NASDAQ: CAPR) stock plunged 53% after the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) rejecting its ...