News

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 ...
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 ...
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 ...
BioSpace1d
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 ...
STAT1d
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 ...
Fierce Biotech1d
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 ...
BioPharma Dive1d
FDA turns back Capricor’s Duchenne cell therapy
The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the ...
The Pharma Letter1d
FDA slaps CRL on Capricor’s deramiocel BLA
US biotech Capricor Therapeutics today revealed receipt of a Complete Response Letter (CRL) from the US Food and Drug ...
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.
Capricor Therapeutics, Inc. (NASDAQ: CAPR) Securities Fraud Investigation; CAPR Investors Urged to Contact Award-Winning Firm, Gibbs Mura
Shares of Capricor Therapeutics, Inc. plunged over 30% in intraday trading on Friday, July 11, 2025, after the U.S. Food and Drug Administration rejected the company’s Biologics License Application ...
Capricor Therapeutics Shares Plunge Premarket on FDA Setback
Capricor Therapeutics shares plummeted in premarket trading Friday after the U.S. Food and Drug Administration turned away the biotechnology company's bid for approval of Deramiocel, its lead ...