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 Biotech5d
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 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 ...
BioSpace6h
FDA Layoffs, 200 Rejection Letters, User Fees and Priority Vouchers, Bad Week for Rare Disease
Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees ...
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 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 ...
BioSpace5d
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 ...
STAT5d
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 ...
MedCity News5d
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 ...
Morningstar5d
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 ...
STAT5d
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 ...
U.S. News & World Report5d
Capricor Shares Sink as US FDA Declines to Approve Cell Therapy - U.S. News
FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo By Christy Santhosh ...