Incyte gains FDA Breakthrough designation for its candidate against essential thrombocythemia
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Incyte has received FDA Breakthrough Therapy designation for its experimental treatment INCA033989, targeting essential thrombocythemia. This designation aims to expedite the development of treatments showing promise, based on Phase 1 data indicating good tolerability and platelet count normalization. The treatment is for patients with CALR mutations type 1 and non-type 1. Incyte plans to launch a registry program in H1 2026 for patients resistant to existing therapies, marking a strategic move in rare myeloproliferative diseases.
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