11:12 AM EDT, 09/25/2025 (MT Newswires) -- Capricor Therapeutics ( CAPR ) shares were up 5% in recent Thursday trading after it reported a regulatory update on its biologics license application for deramiocel, its investigational Duchenne muscular dystrophy therapy, following a recent Food and Drug Administration Type A meeting.

The regulator said that it and Capricor are aligned on endpoints for the HOPE-3 trial, and that the trial should serve as an "additional study" as requested in a July complete response letter, according to the company. The FDA also said HOPE-3 data can be submitted as part of the current BLA, recommending left ventricular ejection fraction as a key secondary endpoint.

The company said it expects HOPE-3 topline results in mid-Q4 and plans to include them in its CRL, seeking a label that reflects both cardiac and skeletal muscle benefits.

Capricor Therapeutics ( CAPR ) said it has sufficient financial resources to support deramiocel's regulatory review and potential launch.

Price: 6.50, Change: +0.31, Percent Change: +5.04