News

Capricor shares sink as US FDA declines to approve cell therapy
The U.S. Food and Drug Administration has declined to approve Capricor Therapeutics' cell therapy for a heart condition, the ...
Capricor Sinks After FDA Rejects Drug for Muscle Disease
Capricor Therapeutics Inc. shares tumbled 35% after US regulators rejected the company’s treatment for a deadly muscle ...
Capricor shares sink after US FDA declines approval for muscle disorder therapy
The U.S. Food and Drug Administration has declined to approve Capricor Therapeutics' cell therapy for a heart condition and ...
Capricor Therapeutics: Buying Opportunity Following FDA's Complete Response Letter
Capricor Therapeutics's dip caused by the CRL is a buying opportunity considering the readout of HOPE-3 within 2-3 months.
STAT3d
FDA rejects Capricor’s cell therapy for Duchenne muscular dystrophy
The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment ...
Fierce Biotech3d
FDA rejects Capricor’s DMD cell therapy, asks for more data
The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy (DMD) cell therapy, raising ...
Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular Dystrophy
FDA issued Complete Response Letter Capricor plans to resubmit its BLA to include data from the ongoing Phase 3 HOPE-3 trial ...
BioSpace3d
Capricor Plunges on FDA Rejection of DMD Cell Therapy
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 ...
The Pharma Letter3d
FDA slaps CRL on Capricor’s deramiocel BLA
US biotech Capricor Therapeutics today revealed receipt of a Complete Response Letter (CRL) from the US Food and Drug ...
Capricor: Maintaining Hold Rating In Light Of Deramiocel Complete Response Letter
Capricor Therapeutics is expected to release data from the phase 3 HOPE-3 trial in Q3'25, thus presenting a potential path ...
Capricor Therapeutics: FDA Rejects Bid for Deramiocel Approval
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 ...
Nasdaq3d
Capricor Therapeutics to Resubmit BLA for Deramiocel Following FDA ...
Capricor plans to resubmit BLA for Deramiocel after FDA Complete Response Letter, aiming for approval pending additional trial data.