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Capricor, FDA 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,

Fierce Biotech · 2d

FDA rejects Capricor’s DMD cell therapy, asks for more data

BioSpace · 2d

Capricor Plunges on FDA Rejection of DMD Cell Therapy

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 ...

STAT2d

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 News2d

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 ...

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