Prime Medicine Surges 12% on FDA Clearance for Gene Editing Therapy PM647

Prime Medicine Inc (NASDAQ: PRME) shares gained over 12% in after-hours trading following FDA clearance of its Investigational New Drug (IND) application for PM647 🔗.

PM647 is an in vivo gene editing therapy targeting Alpha-1 Antitrypsin Deficiency (AATD), designed to correct the E342K mutation in the SERPINA1 gene. The planned Phase 1/2 clinical trial will evaluate safety, tolerability, and preliminary efficacy in adults with AATD 🔗.

This marks the company's second regulatory milestone, following clearance for PM577a, and aims to address both liver and lung manifestations of AATD, a condition with no approved curative treatment for its underlying genetic cause 🔗.