FDA indicated to Capricor that it  will  be unable to approve Deramiocel without additional data

Capricor Therapeutics announced that it has received a Complete Response Letter indicating that the FDA has completed the review of Deramiocel for Duchenne cardiomyopathy, but would be unable to approve the application in its current form.  Capricor shared that the letter cites that their application does not meet the statutory requirement for substantial evidence of effectiveness, and that the FDA has asked for additional data.   Capricor, which received early funding from CureDuchenne, plans to resubmit their application in Q3 2025 with data from their ongoing Phase 3 HOPE-3 trial. 

Link to Press Release:

https://www.capricor.com/investors/news-events/press-releases/detail/319/capricor-therapeutics-provides-regulatory-update-on