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 ...

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 ...

Dyne Therapeutics, Inc. (NASDAQ: DYN) is one of the 13 Best Healthcare Stocks to Buy Under $10. In a report released on July ...

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 ...