Capricor Soars on Key FDA Regulatory Breakthrough

A Constructive Shift from Regulators

Shares of Capricor Therapeutics experienced a significant 10% surge yesterday, closing at $6.79. This substantial gain was driven by a pivotal clarification from the U.S. Food and Drug Administration (FDA) concerning the regulatory pathway for its stem cell therapy, Deramiocel.

The recent development marks a notable turnaround for the biotechnology firm. Following a Type-A meeting with the regulatory agency, Capricor confirmed that the FDA has agreed to accept the already-completed HOPE-3 clinical study. This study will serve as the “additional study” requested in the Complete Response Letter issued back in July 2025. This agreement is a critical step, allowing the company to integrate the HOPE-3 data directly into its existing Biologics License Application (BLA), thereby facilitating a faster resumption of the review process.