FDA clears IND for Prelude's JAK2V617F inhibitor PRT12396; Phase 1 to start by Q2 2026

Prelude Therapeutics Inc

FDA cleared IND for PRT12396, a mutant-selective JAK2V617F inhibitor for myeloproliferative neoplasms.
Phase 1 study in polycythemia vera and myelofibrosis to initiate by Q2 2026.
PRT12396 is subject to an exclusive option agreement with Incyte (announced Nov 2025).
JAK2V617F mutation drives ~95% of PV, 60% of ET, and 55% of MF cases.
Open-label Phase 1 will assess safety, efficacy, and PK profile.

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