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Cogent's Bezuclastinib NDA Accepted For Advanced Systemic Mastocytosis; PDUFA Set For June 2027
Source: Nasdaq
Healthcare & BiotechRegulation & Legislation
Cogent Biosciences' NDA for bezuclastinib in adults with advanced systemic mastocytosis has been accepted by the FDA. The agency set a PDUFA target action date of June 29, 2027, advancing the drug into the formal U.S. regulatory review process and providing a defined potential approval catalyst for COGT.
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