Cogent Biosciences Soars 120% on Breakthrough Phase 3 Results for Bezuclastinib in GIST Treatment

Cogent Biosciences (NASDAQ: COGT) shares skyrocketed over 120% after the biotech company announced groundbreaking results from its Phase 3 PEAK trial evaluating bezuclastinib in combination with sunitinib for patients with gastrointestinal stromal tumors (GIST). The pivotal study revealed that the combination therapy achieved a median progression-free survival of 16.5 months, significantly outperforming sunitinib monotherapy, which showed 9.2 months. This result represents a 50% reduction in the risk of disease progression or death, marking the first major advancement for second-line GIST patients in more than two decades.

The trial also showed a strong objective response rate of 46% for the combination treatment, compared to 26% for sunitinib alone, further solidifying the therapy’s potential to redefine GIST management. Dr. Neeta Somaiah, M.D., Professor and Department Chair at The University of Texas MD Anderson Cancer Center, described the results as “transformative and practice changing,” emphasizing that the therapy is likely to become the new standard of care following regulatory approval.

The treatment was generally well tolerated, showing no new safety concerns beyond those already known for sunitinib. The most common Grade 3 or higher adverse events were hypertension, neutropenia, and elevated liver enzymes.

Cogent CEO Andrew Robbins celebrated the findings, calling it “a historic day” for both the company and GIST patients. Robbins highlighted that the bezuclastinib-sunitinib combination is “poised to become the new standard of care” in second-line GIST treatment. Cogent plans to file a New Drug Application (NDA) for the therapy in the first half of 2026.

In addition to GIST, Cogent continues advancing bezuclastinib in systemic mastocytosis, with results from its APEX trial expected in December 2025 and an NDA submission for Non-Advanced Systemic Mastocytosis planned by year-end 2025.