Prelude receives FDA clearance for investigational IND for PRT12396

Prelude Therapeutics (PRLD) announced that the U.S. Food and Drug Administration, FDA, cleared the Company to proceed with a Phase 1 study under its Investigational New Drug Application, IND, for PRT12396, a mutant-selective JAK2V617F inhibitor being developed for the treatment of patients with certain myeloproliferative neoplasms. The Company anticipates dosing the first patient by Q2 of 2026. “The FDA’s clearance of our IND for PRT12396 marks a pivotal first milestone in the strategic transformation and development focus on our JAK2 and KAT6 programs that we outlined last quarter,” stated Kris Vaddi, Chief Executive Officer of Prelude. “This achievement demonstrates our ability to translate high-quality science rapidly into clinical progress and our clear focus on executing these programs that represent the potential to reshape the treatment landscape for the target patient populations. We look forward to advancing PRT12396 into the phase 1 study in patients with polycythemia vera and myelofibrosis in parallel.”