Guess the Therapy Answer February 25, 2026

Which investigational cell therapy in development for Duchenne by Capricor Therapeutics received a CRL from the FDA in 2025?

Answer: Deramiocel (previously known as CAP-1002)

See below for further reading on Deramiocel:

In Response to FDA’s Release of Full CRL for Deramiocel, Capricor Publishes Full Response to the Agency

September 12, 2025 — Following the FDA’s public release of the full complete response letter (CRL) that it issued to Capricor Therapeutics for the company’s biologics license application (BLA) for deramiocel, an investigational allogeneic cardiosphere-derived cell therapy intended for the treatment of Duchenne muscular dystrophy (DMD) cardiomyopathy, Capricor has responded by publishing its full response to the agency.

Capricor stated that it was not notified in advance by the FDA that the latter would be publishing the CRL publicly on its website. Furthermore, the FDA did not publish Capricor’s response to the CRL, which, according to the company, provides clarifications on the feedback received and insight on its proposed plans to address remaining issues. As such, Capricor published its response to the CRL on its own website.

Capricor Locks in Type A Meeting With the FDA to Discuss the Future of DMD Cardiomyopathy Cell Therapy Candidate Deramiocel

August 11, 2025 — Capricor Therapeutics has scheduled a Type A meeting with the FDA to discuss future regulatory moves for Deramiocel (also known as CAP-1002), an investigational allogeneic cardiosphere-derived cell therapy intended for the treatment of DMD cardiomyopathy.

The company noted that as a result of the meeting’s scheduling, which will focus on the pathway to resubmission of a BLA for Deramiocel, it has rescheduled its release of financial results for the second quarter to August 11, 2025. Capricor will additionally hold a webcast and conference call on that date in which it will provide a corporate update.