Prime Medicine Receives U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for PM359 for the Treatment of Chronic Granulomatous Disease (CGD)

-- 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 p47 phox -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).

GlobeNewsWire • Jun 22, 2026

Prime Medicine Announces New Zealand Clearance of Clinical Trial Application for PM577a in H1069Q-mutated Wilson Disease

-- First clinical authorization for an in vivo Prime Editing therapy from Prime Medicine -- -- PM577a targets the H1069Q mutation in the ATP7B gene, the most prevalent WD-causing allele in North America and Europe --

GlobeNewsWire • Jun 18, 2026

Ocular Therapeutix vs. Prime Medicine: Which Healthcare Stock Is a Better Buy in 2026?

Ocular Therapeutix is transitioning into a major player in the retinal disease market with its lead program, Axpaxli. Prime Medicine is pioneering a DNA technology to search and replace genetic mutations at their source.

The Motley Fool • Jun 15, 2026

Prime Medicine's Prime Editing Is Worth The Risk

Prime Medicine's PM359 data gives the stock some early human validation for its main value driver: Prime Editing. PM359 was essentially their most advanced application of Prime Editing, even though CGD is a relatively niche market because it's a rare disease. Management decided to deprioritize PM359, and instead, it's now focused on applying Prime Editing towards larger TAMs like Wilson Disease and AATD.

Seeking Alpha • Jun 13, 2026

Prime Medicine, Inc. (PRME) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Prepared Remarks Transcript

Prime Medicine, Inc. (PRME) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Prepared Remarks Transcript

Seeking Alpha • Jun 10, 2026

Prime Medicine, Inc. (PRME) Presents at Jefferies Global Healthcare Conference 2026 Transcript

Prime Medicine, Inc. (PRME) Presents at Jefferies Global Healthcare Conference 2026 Transcript

Seeking Alpha • Jun 5, 2026

Prime Medicine to Present at Goldman Sachs 47th Annual Global Healthcare Conference

CAMBRIDGE, Mass., June 03, 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 Allan Reine, M.D.

GlobeNewsWire • Jun 3, 2026

Prime Medicine to Present at Jefferies Global Healthcare Conference

CAMBRIDGE, Mass., May 28, 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 Allan Reine, M.D.

GlobeNewsWire • May 28, 2026

Prime Medicine Reports First Quarter 2026 Financial Results and Provides Business Updates

CAMBRIDGE, Mass., May 07, 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 reported financial results for the quarter ended March 31, 2026 and provided a business update.

GlobeNewsWire • May 7, 2026

Prime Medicine, Inc. (PRME) Reports Q1 Loss, Misses Revenue Estimates

Prime Medicine, Inc. (PRME) came out with a quarterly loss of $0.28 per share versus the Zacks Consensus Estimate of a loss of $0.24. This compares to a loss of $0.4 per share a year ago.

Zacks Investment Research • May 7, 2026