News

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.
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 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 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 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 ...
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 ...
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 ...
MedCity News3d
FDA Turns Down Capricor Cell Therapy for Cardio Complications of Rare ...
Capricor Therapeutics said the FDA asked for more data supporting the efficacy of Deramiocel, the biotech’s off-the-shelf cell therapy for treating the heart complications of Duchenne muscular ...
STAT3d
Questions about the FDA’s ‘radical transparency’ efforts
Happy Friday. Today, we talk about the stem cell fire sale at CIRM, and about the FDA’s move to release a limited batch of ...
Morningstar3d
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 ...