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FDA Accepts Cogent Biosciences' NDA For Bezuclastinib In Patients With Advanced Systemic Mastocytosis

Sep 15, 2026 · 08:02 AM ET· updated 1h ago

NDA supported by positive results from the APEX pivotal trial demonstrating clinically meaningful responses and evidence of disease modification in patients with AdvSMPDUFA target action date set for June 29, 2027

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Why It Matters

Cogent's new medicine got FDA approval to review for a rare blood disease. The medicine showed it could help patients, so watch if the FDA approves it.

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Source: Benzinga · Read the original report at the publisher. Headline and figures shown for context; data may be delayed.

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