Phase 3 PEAK trial results for 2nd-line GIST patients and pivotal APEX results for AdvSM patients expected in November and December, respectively. Breakthrough Therapy Designation granted for bezuclastinib, with NDA filing for NonAdvSM on track for year-end 2025. Pro forma cash position of $430 million expected to fund operations through 2027.

Bezuclastinib abstracts selected for ASH 2025, including SUMMIT data in NonAdvSM. Novel JAK2 V617F mutant-selective candidate to be showcased at ASH 2025. Recent positive results and FDA alignment for SUMMIT NDA submission plan. IND submission for CGT4255 cleared by FDA, Phase 1 trial set to begin in November.

Financial results for Q3 2025: Cash position of $390.9 million, sufficient to fund operations into 2027. R&D expenses of $69.0 million, G&A expenses of $14.4 million, net loss of $80.9 million. Inducement grants approved for five new employees under Nasdaq listing rule. Milestones include top-line results from PEAK and APEX trials, NDA filing for bezuclastinib by year-end 2025.

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