Prime Medicine Receives U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for PM359 for the Treatment of Chronic Granulomatous Disease (CGD)
Prime Medicine, Inc. announced that the U.S. FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to PM359 for the treatment of p47 phox-deficient chronic granulomatous disease (CGD). This designation is based on promising Phase 1/2 clinical data, including results published in The New England Journal of Medicine, which showed PM359's potential to provide a one-time, disease-modifying treatment. The RMAT designation will facilitate expedited development and review, adding to existing Fast Track, Orphan Drug, and Rare Pediatric Disease Designations for PM359.
https://www.globenewswire.com/news-release/2026/06/22/3315247/0/en/prime-medicine-receives-u-s-fda-regenerative-medicine-advanced-therapy-rmat-designation-for-pm359-for-the-treatment-of-chronic-granulomatous-disease-cgd.html