Cogent Biosciences, Inc. (NASDAQ: COGT) experienced a dramatic surge in its stock price on Monday, November 10, 2025, climbing approximately 120% in premarket trading to $32.25 from a previous close of $14.72. The remarkable jump followed the company’s announcement of highly encouraging late-stage clinical trial results for bezuclastinib, its lead drug candidate targeting a rare form of gastrointestinal cancer.
The biotech firm disclosed top-line data from its Phase 3 PEAK trial, which demonstrated that the combination of bezuclastinib with sunitinib significantly outperformed sunitinib monotherapy in patients with imatinib-resistant or intolerant Gastrointestinal Stromal Tumors (GIST). This represents the first positive Phase 3 trial in second-line GIST patients in over two decades, positioning the Massachusetts-based company for potential regulatory approval and market entry in 2026.
Phase 3 PEAK Trial: Breakthrough Results in GIST Treatment
The Phase 3 PEAK trial results revealed compelling efficacy data for the bezuclastinib-sunitinib combination therapy. According to data as of September 30, 2025, patients receiving the combination treatment demonstrated a median progression-free survival of 16.5 months compared to just 9.2 months for those on sunitinib monotherapy alone—representing a 50% reduction in the risk of disease progression or death.
Additionally, the objective response rate reached 46% in the combination arm versus 26% for sunitinib alone, indicating that nearly half of patients experienced measurable tumor shrinkage with the dual therapy approach.
The safety profile of bezuclastinib proved manageable and consistent with expectations. Only approximately 13% of patients in the combination arm experienced ALT/AST liver enzyme elevations, with just 1.5% discontinuing bezuclastinib therapy as a result. Importantly, no unique safety concerns were identified beyond the established safety profile of sunitinib, with common Grade 3+ adverse events including hypertension, neutropenia, and elevated liver enzymes.
Dr. Neeta Somaiah from MD Anderson Cancer Center called the results “truly transformative and practice changing,” expressing confidence that the combination would be rapidly adopted as the new standard of care following regulatory approval.
Cogent Biosciences announced it remains on track to submit a New Drug Application (NDA) for the tyrosine kinase inhibitor for GIST in the first half of 2026. The company has already received FDA Breakthrough Therapy Designation for bezuclastinib, which may expedite the regulatory review process.
CEO Andrew Robbins described the announcement as “a historic day” for both the company and GIST patients, noting that the combination therapy is “poised to become the new standard of care” for second-line treatment in this patient population.
COGT Surges Past Analyst Price Targets After PEAK Data
The premarket surge of 117.61% brought COGT shares to $32.25 at 9:04:22 AM EST on November 10, 2025, representing one of the most significant single-day gains in the biotechnology sector. Prior to the announcement, the stock had closed at $14.72 on November 7, 2025, showing modest growth of just 0.68%. The company’s market capitalization jumped to approximately $2.07 billion following the premarket spike, reflecting investor enthusiasm about the commercial potential of bezuclastinib in the GIST indication.
Year-to-date performance for COGT has been exceptionally strong even before Monday’s surge, with the stock up 90% compared to the S&P 500’s 14.40% gain over the same period. The one-year return stood at 47.46% prior to the Phase 3 announcement.
Analysts have maintained a bullish outlook on the stock, with HC Wainwright & Co. reiterating a “Buy” rating on November 4, 2025, though their $21 price target appears conservative given the latest developments. The average analyst price target of $23.25 has been exceeded by the current premarket price, suggesting potential for further upward revisions.
Beyond GIST, Cogent Biosciences maintains a robust pipeline with bezuclastinib also in development for systemic mastocytosis. The company has ongoing trials for this indication, with top-line results from its APEX trial expected in December 2025.
Cogent plans to submit its first NDA for bezuclastinib in Non-Advanced Systemic Mastocytosis by the end of 2025, providing additional near-term catalysts for the stock. With $390.89 million in cash as of the most recent quarter, the company appears well-positioned financially to support its regulatory submissions and potential commercial launch activities.