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 told Capricor in a letter that it is unable to approve its application for Deramiocel in its current form as it does ...

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 ...

TAS-205 showed no significant impact on motor function in patients with Duchenne muscular dystrophy (DMD), highlighting the ongoing search for effective treatments for the rare condition.

Capricor Therapeutics (NASDAQ:CAPR) saw its stock plummet by 53% on Friday after the U.S. Food and Drug Administration issued a Complete Response Letter (CRL), rejecting the company’s bid for approval ...

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

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.

Capricor, which was seeking approval of Deramiocel for the treatment of cardiomyopathy associated with DMD, said the FDA issued a so-called complete response letter, indicating the agency won't ...

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 ...