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Prelude Therapeutics Receives FDA Clearance of Investigational New Drug Application (IND) for PRT12396, a Mutant-selective JAK2V617F Inhibitor
Phase 1 study of PRT12396 in patients with polycythemia vera and myelofibrosis anticipated to initiate by Q2 2026WILMINGTON, Del., Feb. 03, 2026 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a precision oncology company, today 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 treatmen
About this update from Prelude Therapeutics Incorporated
[{"type":"image","alt":"Prelude Therapeutics, Incorporated","displaySize":"","headline":null,"caption":"Prelude Therapeutics, Incorporated","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":103,"url":"https://media.zenfs.com/en/globenewswire.com/8835d8a0be4b67686e42408eafbca555"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/9HVZo7WrFLmSMiAVkGF1.A--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE0NDtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/8835d8a0be4b67686e42408eafbca555","width":300,"height":103}},"lazy":false},{"type":"text","content":"Phase 1 study of PRT12396 in patients with polycythemia vera and myelofibrosis anticipated to initiate by Q2 2026","length":113,"tagName":"p"},{"type":"text","content":"WILMINGTON, Del., Feb. 03, 2026 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a precision oncology company, today 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 (MPNs). The Company anticipates dosing the first patient by Q2 of 2026.","length":514,"tagName":"p"},{"type":"text","content":"“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.”","length":631,"tagName":"p"},{"type":"text","content":"The Phase 1 study of PRT12396 is an open-label, multi-center, safety and efficacy study in patients with high-risk polycythemia vera (PV) and intermediate and high-risk myelofibrosis (MF). The primary endpoints of the study include safety, efficacy and PK profile.","length":264,"tagName":"p"},{"type":"text","content":"The JAK2V617F inhibitor program is subject to an exclusive optio...