On Wednesday, July 29, 2026, the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) will meet to review Capricor Therapeutics’ Biologics License Application (BLA) for Deramiocel as a potential treatment for Duchenne.
The meeting marks an important step in the FDA’s review process and provides an opportunity for independent experts to discuss the available evidence and make a recommendation to the FDA. While the Advisory Committee’s recommendation is non-binding, the FDA will consider the committee’s discussion, along with the totality of the evidence, before making its final regulatory decision by the Prescription Drug User Fee Act (PDUFA) action date of August 22, 2026.
Meeting Details
Date and time: Wednesday, July 29, 2026, 9:30 AM – 4:50 PM ET
Location: FDA White Oak Campus, 10903 New Hampshire Ave, Building 31, Room 1503, Silver Spring, MD 20993
The meeting will also be available to the public via the FDA’s online webcast.
The committee is expected to hear:
- Presentations from the FDA review team
- A presentation from Capricor Therapeutics
- Public comments during the Open Public Hearing
- Committee discussion and voting on questions posed by the FDA
The meeting agenda, webcast information, and other materials are available on the FDA’s Advisory Committee webpage.
You Can Still Submit Written Comments
Thank you to everyone who submitted written comments by the deadline for inclusion in the Advisory Committee briefing materials.
If you missed that deadline, you can still submit comments to the FDA docket. While they will not be provided to Advisory Committee members before the meeting, comments submitted on or before July 28, 2026, will continue to be considered by the FDA as part of its ongoing review of Deramiocel. Check out our previous blog for more information and helpful tips for submitting written comments.
Every voice matters, and we encourage members of the Duchenne community to continue sharing their experiences and perspectives.
Join PPMD for a Town Hall Webinar
Following the Advisory Committee meeting, PPMD and our advocacy partners will host a town hall webinar on Tuesday, August 4 at 1:00 PM ET, to review what happened during the meeting, discuss next steps in the FDA review process, and answer questions from the Duchenne community.
During the webinar, PPMD and our advocacy partners will:
- Review the Advisory Committee discussion and vote
- Explain what the committee’s recommendation means—and what it does not mean
- Discuss next steps leading up to the FDA’s August 22 PDUFA action date
- Answer questions from individuals and families
Whether you watched the Advisory Committee meeting or are looking for a clear overview afterward, we encourage you to join us.
Looking Ahead
PPMD will continue to monitor the FDA review process and provide timely, accurate updates throughout the week. Following the Advisory Committee meeting, we’ll share a recap of the discussion, explain what comes next, and continue to share information as possible.
Thank you to everyone who has shared their voice and participated in this important process. Your engagement helps ensure that the lived experiences of individuals and families living with Duchenne remain at the forefront of the regulatory conversation.
The post What to Know Ahead of This Week’s Deramiocel FDA Advisory Committee Meeting appeared first on Parent Project Muscular Dystrophy.