Capricor Therapeutics's dip caused by the CRL is a buying opportunity considering the readout of HOPE-3 within 2-3 months.

Shares of Capricor Therapeutics CAPR tanked 33% on Friday after it announced that the FDA issued a complete response letter ( ...

Capricor plans to resubmit its application for the approval of deramiocel for DMD after the FDA declined to accept the ...

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

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

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

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 ...

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

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

Capricor’s BLA for Deramiocel was granted Priority Review in March 2025 and was supported by data from the HOPE-2 trial, its open-label extension (OLE), and natural history comparisons from FDA-funded ...

In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy associated with Duchenne muscular dystrophy. The decision comes after CBER ...