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

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

Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees ...

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

Join the case to recover your losses. The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation. This press ...

FDA issued Complete Response Letter Capricor plans to resubmit its BLA to include data from the ongoing Phase 3 HOPE-3 trial ...

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

Capricor slumps 33% as the FDA rejects its BLA for DMD drug, deramiocel, citing lack of effectiveness data and CMC issues.

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 ...

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