News Related to Advanced Systemic Mastocytosis

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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.

Cogent Biosciences Reports Deepening Clinical Benefit for Bezuclastinib in Systemic Mastocytosis

Mar 01, 2026

Cogent Biosciences presented additional SUMMIT trial data showing bezuclastinib achieved 56% improvement in symptoms at 48 weeks in NonAdvSM patients, with multiple regulatory submissions advancing toward expected commercial launch in second half of 2026.