Prelude Therapeutics Receives FDA Clearance for Mutant-selective JAK2V617F Inhibitor PRT12396.

Prelude Therapeutics has received FDA clearance for a Phase 1 study of PRT12396, a mutant-selective JAK2V617F inhibitor for treating myeloproliferative neoplasms. The study aims to assess safety, efficacy, and PK profile in patients with high-risk polycythemia vera and intermediate and high-risk myelofibrosis. Prelude expects to dose the first patient by Q2 2026. This marks a significant milestone in the company's strategic transformation and development focus on JAK2 and KAT6 programs.