Bezuclastinib and SUTENT (sunitinib) - (PEAK)

November 5, 2026: Cogent Biosciences (NASDAQ: COGT) reported Q3 2026 updates centered on bezuclastinib. The company said it is preparing for a potential GIST launch ahead of a November 30, 2026 PDUFA date. Additional bezuclastinib FDA action dates are December 30, 2026 for non-advanced systemic mastocytosis (NonAdvSM) and June 29, 2027 for advanced systemic mastocytosis (AdvSM); the company also said FDA accepted the NDA for bezuclastinib in AdvSM.

For clinical development, Cogent plans multiple ASH 2026 posters (December 12-15, New Orleans) with detailed SUMMIT analyses in NonAdvSM, including skin and neurocognitive symptoms, longer-term pathobiology follow-up, an MS2D2 symptom-burden comparison, and first clinical results from a SUMMIT substudy evaluating switching from avapritinib to bezuclastinib. The company also initiated a single-arm, 40-patient PEAK extension cohort testing bezuclastinib plus sunitinib in first-line GIST, designed to prospectively assess ORR and PFS in patients with exon 9 or exon 11 primary mutations.

Pipeline milestones: planned Q4 2026 IND submissions for CGT1815 (pan-KRAS(ON)) and CGT1145 (JAK2 V617F), and completion of dose escalation for CGT4255. Cash, cash equivalents, and marketable securities were $791.1 million as of September 30, 2026, which the company said should fund operations into late 2028.