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FDA, Capricor and cell therapy

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 questions about whether the agency's new leadership may be rowing back from some of the flexibility shown by the old regime. Capricor’s share price fell 38% to $7.11 in premarket trading.

Zacks.com on MSN · 3h

FDA Rejects CAPR's Cell Therapy BLA for Genetic Disorder, Stock Tanks

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

Reuters on MSN · 3d

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 asked for more data, the drugmaker said on Friday, sending its shares 50% lower in premarket trading.

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.

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

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 ...

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 ...

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 ...

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