Prelude Therapeutics Inc. (PRLD) announced that the FDA has cleared its Investigational New Drug Application (IND) for PRT12396, a mutant-selective JAK2V617F inhibitor.
The clearance allows the company to initiate a Phase 1 clinical trial of PRT12396 in patients with polycythemia vera and myelofibrosis, with dosing expected to begin by the second quarter of 2026.
PRT12396 is designed to selectively target the JAK2V617F mutation, which is present in the majority of polycythemia vera patients and a significant proportion of those with essential thrombocythemia or primary myelofibrosis.
Currently, JAK2 inhibitors often lack selectivity, leading to off-target effects, so Prelude's approach aims to deliver more precise and tolerable treatment options.
Prelude's pipeline also includes KAT6 inhibitors in preclinical development and other precision oncology assets targeting genetically defined cancers.
PRLD has traded between $0.61 and $4.22 over the past year. The stock is currently trading at $2.20, up 8.37%.
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