The U.S. Food and Drug Administration has extended its review of Capricor Therapeutics’ biologics license application for deramiocel to November 22, 2026, three months beyond the original target date of August 22, 2026.
The extension follows the Center for Biologics Evaluation and Research’s acceptance of a major amendment to the submission, which included 24-month data from the HOPE-3 open-label extension study and additional analyses. The revised proposed indication focuses on upper limb function, aligning with the primary endpoint evaluated in the HOPE-3 study.
The FDA’s decision to extend the review period allows additional time for assessment of the amended application. Earlier this year, an advisory committee voted 9 to 3 against approval, increasing regulatory risk for the biotech firm.
HC Wainwright maintained a Neutral rating on Capricor’s stock, citing continued high regulatory risk despite the submission of new data. The firm plans to reassess its position once further regulatory feedback on the application is received.
The key question remains whether the 24-month HOPE-3 extension data and supplementary analyses will sufficiently address the FDA’s concerns to support approval for the refined indication.
