Welcome to our dedicated page for Prime Medicine news (Ticker: PRME), a resource for investors and traders seeking the latest updates and insights on Prime Medicine stock.
Prime Medicine, Inc. develops genetic medicines using its proprietary Prime Editing platform, which is designed to make targeted edits within genes. News about PRME centers on its pipeline for genetically defined diseases, including PM577 for Wilson Disease, PM647 for Alpha-1 Antitrypsin Deficiency and PM359, an investigational autologous hematopoietic stem cell product for p47phox chronic granulomatous disease.
Company updates also cover financial results, regulatory interactions, clinical-data publications, investor conference participation and finance leadership changes. Additional recurring themes include an in vivo cystic fibrosis program supported by the Cystic Fibrosis Foundation and Prime Edited CAR-T product development with Bristol Myers Squibb for hematology, immunology and oncology.
Prime Medicine (Nasdaq: PRME) announced that the U.S. FDA has cleared its Investigational New Drug (IND) application for PM577a, an investigational in vivo Prime Editor for Wilson disease (WD). This clearance allows PM577a to proceed to clinical study in the United States.
Combined with a previously cleared Clinical Trial Application in New Zealand, the IND supports a global Phase 1/2, first-in-human, open-label trial in adults and adolescents with WD carrying the H1069Q mutation in the ATP7B gene, a prevalent WD-causing allele in North America and Europe. The trial will assess safety, tolerability, biological activity and efficacy across ascending doses, with planned evaluations including copper-related biomarkers and hepatic copper by biopsy. Trial initiation is expected in the second half of 2026, with initial clinical data anticipated in 2027.
Prime Medicine (Nasdaq: PRME) reported a binding arbitration win against Beam Therapeutics regarding PM647 for Alpha-1 Antitrypsin Deficiency (AATD).
The tribunal confirmed PM647 is within Prime Medicine’s contractual field, found no breach, and awarded no damages. Prime plans an IND/CTA for PM647 in Q3 2026, with initial clinical data in 2027.
Prime Medicine (Nasdaq: PRME) received U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) designation for PM359, an investigational autologous Prime Edited stem cell therapy for p47phox-deficient chronic granulomatous disease (CGD).
The RMAT decision, based on Phase 1/2 data in two patients, adds to Fast Track, Orphan Drug, and Rare Pediatric Disease designations and enables intensive FDA interaction plus eligibility for rolling and priority BLA review.
Prime Medicine (Nasdaq: PRME) received New Zealand Medsafe clearance for a Clinical Trial Application for PM577a, an investigational in vivo Prime Editing therapy targeting the H1069Q ATP7B mutation in Wilson Disease.
This first clinical authorization for Prime Medicine’s in vivo Prime Editing enables a global open-label Phase 1/2 trial, expected to start in the second half of 2026, with initial data anticipated in 2027.
Prime Medicine (Nasdaq: PRME) announced that CEO Allan Reine, M.D., will participate in a fireside chat at the Goldman Sachs 47th Annual Global Healthcare Conference on June 10, 2026, at 10:40 a.m. ET in Miami Beach, FL.
A live audio webcast and 90-day replay will be available in the News & Events section of Prime Medicine’s website.
Prime Medicine (Nasdaq: PRME) announced that CEO Allan Reine, M.D., will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 4, 2026, at 12:50 p.m. ET in New York.
A live audio webcast and a 90-day replay will be available in the News & Events section of the company’s website.
Prime Medicine (Nasdaq: PRME) reported Q1 2026 results and program updates on May 7, 2026. Key points: cash and investments $149.2M as of March 31, 2026, providing a runway into 2027; net loss $49.1M for Q1; R&D $34.1M and G&A $17.4M. The company is on track to file IND/CTA for PM577 (Wilson Disease) H1 2026 and PM647 (AATD) mid-2026, with initial clinical data expected in 2027, and continues regulatory dialogue toward a potential BLA for PM359 (CGD).
Prime Medicine (Nasdaq: PRME) appointed Svetlana Makhni as Chief Financial Officer, effective April 16, 2026. Ms. Makhni will lead financial operations, investor relations, financial planning and corporate development.
She brings over 20 years of biotech and investment banking experience, including prior CFO roles and work on strategic transactions with Ipsen and Gilead Sciences. The company said her hire supports planned clinical entry for Wilson Disease and Alpha-1 Antitrypsin Deficiency and broader Prime Editing programs.
Prime Medicine (Nasdaq: PRME) reported full‑year 2025 results and provided program updates on March 3, 2026. Key clinical and financial points: cash and investments $191.4M, net loss $201.1M, R&D $160.6M and G&A $52.3M. The company plans IND/CTA filings for Wilson Disease and AATD in 1H and mid‑2026, with initial clinical data expected in 2027.
Regulatory progress includes ongoing FDA engagement for PM359 in CGD and intent to submit a BLA; NEJM publication of PM359 Phase 1/2 data was announced.
Prime Medicine (Nasdaq: PRME) said management will participate in three investor conferences in early March 2026: TD Cowen (fireside chat, Mar 4, 2026, 1:10 p.m. ET, Boston), Jefferies Biotech on the Beach (1x1 meetings, Mar 10, 2026, Miami Beach) and Citizens Life Sciences (fireside chat, Mar 11, 2026, 2:15 p.m. ET, Miami Beach).
Live audio webcasts of the fireside chats will be available under Events & Presentations on the company website, with replays accessible for 90 days.