08:07 AM EDT, 08/14/2026 (MT Newswires) -- Capricor Therapeutics ( CAPR ) stock surged over 98% in Friday's premarket after the company said the US Food and Drug Administration is willing to review an amendment to its biologics license application for deramiocel, potentially shifting the drug's focus to upper-limb skeletal muscle function in Duchenne muscular dystrophy.

The company, in its quarterly earnings call, said it plans to submit 24-month data from the HOPE-3 study and additional analyses supporting the revised indication.

The FDA has indicated it may extend the review timeline to consider the amendment, Capricor said. The timing of the submission has not been finalized.

The development follows a 9-3 FDA advisory committee vote against deramiocel's efficacy for DMD-related cardiomyopathy. However, the committee was directionally supportive of evidence related to upper-limb function, it said.