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

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

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

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.

Capricor Therapeutics Inc. shares tumbled 35% after US regulators rejected the company’s treatment for a deadly muscle ...

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 ...

FDA head Marty Makary said the agency may fast-track drugs from companies that “equalize” the cost of medicines between the U ...

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 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 ...

The company said it was optimistic that the issues identified by the Food and Drug Administration could be resolved with new data.