Cogent Biosciences Inc. (NASDAQ: COGT) announced it has completed submission of a new drug application to the U.S. Food and Drug Administration for bezuclastinib in patients with gastrointestinal stromal tumors who have received prior treatment with imatinib.

The application was submitted under the FDA's Real-Time Oncology Review program based on positive results from the Phase 3 PEAK trial. Bezuclastinib received Breakthrough Therapy Designation for GIST treatment earlier this year.

In the PEAK trial, bezuclastinib in combination with sunitinib demonstrated a median progression-free survival of 16.5 months compared to 9.2 months for sunitinib alone. The combination reduced the risk of disease progression or death by 50% with a hazard ratio of 0.50. The objective response rate was 46% for the combination versus 26% for sunitinib monotherapy.

"We are excited to complete our PEAK NDA submission which marks a significant step toward bringing a new therapy to patients with second-line GIST," said Andrew Robbins, President and Chief Executive Officer.

The company plans to present full results from the PEAK trial at a medical meeting during the first half of 2026. Cogent also plans to initiate a Phase 2 trial this quarter investigating the bezuclastinib plus sunitinib combination for first-line GIST patients with exon 9 mutations. An NDA submission for bezuclastinib in Advanced Systemic Mastocytosis remains on track for the first half of 2026.

The company also announced equity grants to six new employees totaling nonqualified options for 21,100 shares and 15,700 restricted stock units under its 2020 Inducement Plan.