Cogent Biosciences Receives Key FDA Designation for Gastrointestinal Cancer Therapy

Clinical Data Underpinning the Decision
Results from the PEAK study demonstrated that the combination therapy significantly extended progression-free survival (PFS) for the indicated patient population. An independent, blinded central review (BICR) showed a median PFS of 16.5 months for patients receiving the combination, compared to 9.2 months for those on sunitinib alone. The hazard ratio for progression or death was 0.50 (95% CI: 0.39–0.65), indicating a 50% reduction in risk relative to the monotherapy. Cogent reported that the safety profile of the combination was consistent with the known profile of sunitinib, with no new safety signals identified.

Accelerated Path to Market
The Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious conditions. Cogent Biosciences is leveraging this by planning to complete its New Drug Application (NDA) submission for the bezuclastinib combination in April 2026. The company will utilize the FDA’s Real-Time Oncology Review (RTOR) program, which facilitates a rolling submission of application components and can potentially shorten the overall review timeline.

The full dataset from the PEAK trial is scheduled for presentation at a major medical conference in the first half of 2026. Looking further ahead, Cogent is targeting a potential commercial launch in the second half of 2026, pending regulatory approval.

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Broader Development Strategy and Financial Position
Beyond this GIST indication, bezuclastinib is also being developed for systemic mastocytosis. The company anticipates several near-term regulatory milestones for these programs, including FDA acceptance of an NDA for non-advanced systemic mastocytosis (NonAdvSM) by the end of February 2026 and submission of an NDA for advanced systemic mastocytosis (AdvSM) in the first half of 2026.

Furthermore, Cogent plans to initiate a Phase 2 study by mid-2026 to evaluate the bezuclastinib combination as a first-line treatment for GIST patients with Exon 9 mutations.

The biotech firm entered 2026 with a strong cash position of approximately $900 million. Management states these funds are sufficient to support operations and planned commercial launches well into 2028.