The FDA has scheduled an Advisory Committee meeting for July 29, 2026 to review Deramiocel, Capricor’s investigational cell therapy for Duchenne muscular dystrophy. The meeting will be held virtually, and a live stream will be available for public viewing.
The Duchenne community is actively working together to prepare for this important meeting. Following the announcement, PPMD convened Duchenne advocacy partners to align on how we can collaborate and deliver a clear, unified message about the urgent unmet need in Duchenne and the potential role of new therapies like Deramiocel.
We need your voice on July 29th. Join us in ensuring that patient, caregiver, and scientific perspectives are fully represented to help inform FDA and its Advisory Committee as they evaluate this therapy. Whether you plan to submit written testimony or participate in public testimony efforts, our community is strongest when we work together.
How to Submit Written Testimony
Submitting written testimony is a critical way to share your perspective. All written comments are compiled and provided to FDA Advisory Committee members in advance of the meeting and play an important role in shaping their understanding.
We strongly encourage members of the Duchenne community – including families, clinicians, and researchers – to submit comments.
Written testimonies must be submitted on or before July 20th via the FDA public docket. Submissions should include the appropriate docket number (FDA-2026-N-6771) listed in the Federal Register notice for the Cellular, Tissue, and Gene Therapies Advisory Committee meeting for Deramiocel.
What Should You Include in Your Testimony?
Your comments should reflect your lived experience with Duchenne and, if applicable, your perspective on disease progression, cardiac impacts, and treatment needs.
The Advisory Committee will review extensive clinical and scientific data and will be asked to weigh the safety and potential benefits of Deramiocel. Your voice helps ensure that the real-world impact of Duchenne – and what matters most to patients and families – is clearly understood.
By submitting written testimony, you help FDA incorporate patient priorities into their evaluation.
PPMD and our partners have developed a written comment guide to support you in drafting your testimony, including key themes to consider and step-by-step submission instructions.
Support with Your Submission
While all testimonies must be submitted directly to the FDA, PPMD and our partner organizations are available to review drafts and provide feedback.
If you would like support, please email your draft to lauren@parentprojectmd.org by July 15th.
Watch the Meeting
The Advisory Committee meeting will be livestreamed on July 29, 2026. While public viewing is open, participation during the Open Public Hearing (OPH) portion will be limited to individuals selected by the FDA.
Additional details on how to access the livestream will be shared as they become available.
Together, the Duchenne community will continue working to ensure this Advisory Committee meeting is as impactful as possible. If you have questions or would like to get involved, please contact lauren@parentprojectmd.org.
Watch the Webinar Recording
PPMD and our advocacy partners hosted a community webinar on July 7th focused on how our community can engage in the upcoming FDA Advisory Committee meeting for Deramiocel.
We are working together to help coordinate community engagement in the OPH process, as available speaking slots are limited and can be subject to a lottery. By coordinating our efforts across organizations, we can help ensure the broadest possible representation of experiences, avoid unnecessary duplication, and maximize the number of unique community voices that may be heard during the meeting.
If you are interested in requesting an OPH speaking opportunity, please complete our interest form as soon as possible. Completing this form allows our organizations to work together to support applicants, coordinate participation, and help make the strongest possible case for a diverse group of speakers.
The post Preparing for the Deramiocel FDA Advisory Committee Meeting: How to Submit Written Testimony appeared first on Parent Project Muscular Dystrophy.