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

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

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

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 ...