10:34 AM EDT, 09/09/2025 (MT Newswires) -- Capricor Therapeutics ( CAPR ) said Tuesday it has posted the preliminary response it sent to the US Food and Drug Administration on its website after the agency released the complete response letter regarding the company's biologics license application for deramiocel.

Capricor said the preliminary response provides clarifications to the agency's feedback and outlines its plan to address the outstanding issues.

The FDA issued the letter in July, saying that deramiocel, a potential treatment for cardiomyopathy associated with Duchenne muscular dystrophy, did not meet the statutory requirement for substantial evidence of effectiveness.

Capricor said it is awaiting minutes from a recent Type A meeting with the FDA, expected later this quarter, which will help determine next steps in the regulatory pathway. The company also expects topline data from its phase 3 HOPE-3 trial in Q4 and plans to use those results to support resubmission of its application.

Shares of Capricor Therapeutics ( CAPR ) were down 1.6% in recent trading.

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