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Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) for Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)
Source: GlobeNewswire
Healthcare & BiotechCompany Fundamentals
A New Drug Application (NDA) is supported by positive results from the pivotal APEX trial in advanced systemic mastocytosis (AdvSM). The trial demonstrated clinically meaningful patient responses and evidence of disease modification, materially strengthening the drug's regulatory case and commercial outlook.
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