-- RMAT designation granted based on Phase 1/2 clinical data, including results previously published in The New England Journal of Medicine, demonstrating PM359’s potential to address unmet need in p47phox-deficient CGD --

-- Designation enables early and intensive FDA engagement, and provides eligibility for rolling and priority Biologics License Application review --

-- PM359 now holds RMAT, Fast Track, Orphan Drug, and Rare Pediatric Disease Designations --

CAMBRIDGE, Mass., June 22, 2026 (GLOBE NEWSWIRE) -- Prime Medicine, Inc. (NASDAQ:PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to PM359, an investigational autologous Prime Edited hematopoietic stem cell therapy for the treatment of p47phox-deficient chronic granulomatous disease (CGD). RMAT designation was granted based on Phase 1/2 clinical data, including data previously published in The New England Journal of Medicine, and will provide the benefits of intensive FDA guidance and expedited review through the program’s development.