Capricor: A Hold Rating With Regulatory FDA Form Given For Deramiocel Advancement

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  Posted by Two Blokes Jun 11 - Filed in Stock - 7 views
  
  I am downgrading Capricor Therapeutics, Inc. stock from Strong Buy to Hold due to FDA Form 483 risks from a Pre-License Inspection of its manufacturing facility. While deramiocel's clinical data for DMD Cardiomyopathy is strong, the unresolved FDA inspection findings create significant regulatory uncertainty for CAPR. The timing of the FDA Advisory Committee meeting and PDUFA date introduces additional risk, as both could be delayed and affect approval prospects.