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FDA, Capricor and cell therapy

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 company said on Friday, sending its shares tumbling 30% in early trading. In its "complete response letter,

BioSpace · 2d

Capricor Plunges on FDA Rejection of DMD Cell Therapy

STAT · 2d

FDA rejects Capricor’s cell therapy for Duchenne muscular dystrophy

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 ...

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 ...

STAT2d

Pharmalittle: We’re reading about a FDA offer on drug reviews, a Moderna Covid approval, and more

FDA head Marty Makary said the agency may fast-track drugs from companies that “equalize” the cost of medicines between the U ...

2don MSN

Capricor shares sink after US FDA declines approval for cell therapy

The U.S. Food and Drug Administration declined to approve Capricor Therapeutics' cell therapy for a heart condition and asked ...

2don MSN

Capricor shares drop after FDA issues complete response letter for lead DMD therapy

Capricor Therapeutics (CAPR) shares fell Friday after the company announced it received a complete response letter from the FDA for its Biologics License Application for Deramiocel.

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