Cogent Biosciences (COGT) Advances Bezuclastinib-Sunitinib Combination With Breakthrough Therapy Designation (BTD)

Cogent Biosciences, Inc. (NASDAQ:COGT) is one of the 11 Best Performing Stocks in the Last 12 Months.

On January 26, 2026, Cogent Biosciences, Inc. (NASDAQ:COGT) announced a major milestone, receiving a Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration. The designation came for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors (GIST) previously treated with imatinib. This win reflects the combination’s potential to significantly improve outcomes in this patient population.

The designation follows the PEAK trial that featured a 50% reduction in risk of disease progression or death compared to sunitinib monotherapy (hazard ratio 0.50, 95% CI: 0.39-0.65). Meanwhile, median progression-free survival stood at 16.5 months compared to 9.2 months for sunitinib alone, while reporting no new safety signals.

Earlier in January, under its Real-Time Oncology Review (RTOR), the FDA agreed to accept Cogent Biosciences, Inc. (NASDAQ:COGT)’s New Drug Application (NDA). This acceptance will accelerate the review, increasing the likelihood of a quicker FDA decision. Looking ahead, management expects to present full PEAK results in early 2026 and begin a Phase 2 trial in mid-2026 for first-line GIST patients with exon 9 mutations.

Cogent Biosciences, Inc. (NASDAQ:COGT) focuses on developing precision therapies that target genetically defined diseases, including selective tyrosine kinase inhibitors for KIT mutations in GIST and related conditions.

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