Capricor Therapeutics shares tumble as FDA rejects Duchenne muscular dystrophy drug application

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  Posted by Two Blokes Jul 11 - Filed in Stock - 7 views
  
  Capricor Therapeutics (NASDAQ:CAPR) shares plummeted more than 26% after it reported the US Food and Drug Administration (FDA) has not approved its Biologics License Application for deramiocel, the company's lead cell therapy candidate for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). In a Complete Response Letter to Capricor, the FDA stated that the application did not meet the statutory requirement for substantial evidence of effectiveness and requested additional clinical data before reconsidering approval.