FDA Clears Prelude Therapeutics' IND Application for JAK2V617F Inhibitor PRT12396

Prelude Therapeutics, Inc. +0.29%

Prelude Therapeutics, Inc.

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Prelude Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug Application (IND) for PRT12396, a mutant-selective JAK2V617F inhibitor. The company plans to initiate a Phase 1 clinical study of PRT12396 in patients with high-risk polycythemia vera and intermediate and high-risk myelofibrosis, with the first patient expected to be dosed by the second quarter of 2026. The study will assess the safety, efficacy, and pharmacokinetic profile of the investigational drug. The JAK2V617F inhibitor program is subject to an exclusive option agreement with Incyte, announced in November 2025.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Prelude Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9647790-en) on February 03, 2026, and is solely responsible for the information contained therein.

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