FDA policy explicitly states it will not grant RMAT designation if an IND is on hold or placed on hold during review3.
No search results indicate recent changes or FDA 'opening the door' to RMAT for therapies on clinical hold as of early 20261234.
Recent examples include FDA lifting holds (e.g., Intellia Therapeutics' MAGNITUDE-2 trial, Tenaya's MyPeak-1) and granting RMAT to therapies not on hold (e.g., Krystal Biotech's KB707, Senti Bio's SENTI-202)12.
FDA placed holds on Regenxbio trials (RGX-111, RGX-121) due to safety concerns, with no RMAT granted1.
RMAT, from the 21st Century Cures Act, offers expedited development for regenerative therapies showing preliminary clinical benefit for serious conditions345.
Sources:
1. https://www.insights.bio/cell-and-gene-therapy-insights/journal/article/3760/longterm-followup-data-and-clinical-holds-define-the-start-of-2026
2. https://www.cgtlive.com/view/fda-activity-recap-december-2025-features-multiple-approvals-rmat-designation-more
3. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenerative-medicine-advanced-therapy-designation
4. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-regenerative-medicine-therapies-serious-conditions-0
5. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/cber-regenerative-medicine-advanced-therapy-rmat-approvals