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Cogent Biosciences Awaits FDA Decision on Bezuclastinib for Systemic Mastocytosis

Mar 16, 2026

Cogent Biosciences has submitted a New Drug Application for bezuclastinib to treat systemic mastocytosis caused by the KIT D816V mutation, with FDA review underway and strong analyst support.

Cogent Biosciences Prepares Up to Three FDA Filings for Bezuclastinib Following Pivotal Wins

Mar 15, 2026

Cogent Biosciences is preparing parallel FDA submissions for bezuclastinib across three indications following positive pivotal trial results, with potential launches beginning in late 2026 and full commercialization expected by early 2027.