Shares of Cogent Biosciences Inc (NASDAQ:COGT) rose 3.4% on Monday after the company disclosed that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for its bezuclastinib regimen used in combination with sunitinib. The designation applies to patients with Gastrointestinal Stromal Tumors - GIST - who have previously received imatinib.
The FDA classification is intended to speed the review of drugs that appear to offer substantial improvement over existing treatments. In this instance, the agency's decision was informed by results from Cogent's PEAK trial. According to the company, the trial showed that the bezuclastinib and sunitinib combination cut the risk of disease progression or death by half relative to the current standard of care.
In a company statement, Andrew Robbins, Cogent's President and Chief Executive Officer, said, "We are excited to announce this Breakthrough Therapy Designation which recognizes the potential for the bezuclastinib combination to substantially improve upon the currently available treatment options for patients with imatinib-resistant GIST."
Cogent also confirmed that the FDA previously agreed to accept the company's New Drug Application under the Real-Time Oncology Review program, a pathway that permits pre-submission of materials to help accelerate the review. The company said it remains on schedule to complete its NDA submission in April 2026.
Key efficacy findings from the PEAK study include median progression-free survival of 16.5 months for patients receiving the bezuclastinib combination versus 9.2 months for those on sunitinib alone. Cogent indicated it will present full results from the trial at a major medical meeting during the first half of 2026.
Looking ahead, the company expects to start a Phase 2 trial in mid-2026 to evaluate the combination as a first-line option in GIST patients harboring exon 9 mutations. These planned activities represent the company's near-term clinical and regulatory milestones tied to the program.
Overall, the FDA Breakthrough designation and the PEAK data offer regulatory momentum for Cogent's program while the company advances toward a formal NDA filing and additional studies planned for 2026.