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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 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,

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 ...

Nasdaq3d

Capricor Therapeutics to Resubmit BLA for Deramiocel Following FDA ...

Capricor plans to resubmit its BLA to the FDA, incorporating data from the ongoing Phase 3 HOPE-3 trial, indicating proactive steps toward potential approval for Deramiocel.

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