Cogent Bio Shares Double on Landmark Cancer Drug Trial Success
Phase 3 results for its GIST therapy bezuclastinib show a significant leap in effectiveness, positioning it as a potential new standard of care.
Shares of Cogent Biosciences (NASDAQ: COGT) more than doubled in early trading Monday after the biotechnology firm announced overwhelmingly positive results from a late-stage trial for its targeted cancer therapy, bezuclastinib.
The stock surged by as much as 128% in pre-market trading after the company revealed its Phase 3 PEAK trial for patients with Gastrointestinal Stromal Tumors (GIST) met its primary endpoint, demonstrating a dramatic improvement in patient outcomes. The rally pushed Cogent's market capitalization to over $2 billion and sent its shares toward a 52-week high.
The pivotal study evaluated bezuclastinib in combination with sunitinib, the current standard of care, for GIST patients whose disease had progressed despite treatment with a first-line therapy. The results, detailed in a company press release, showed the combination therapy achieved a median progression-free survival (mPFS) of 16.5 months. This was a significant extension compared to the 9.2 months for patients receiving sunitinib alone, representing a 50% reduction in the risk of disease progression or death.
Furthermore, the objective response rate (ORR)—a measure of tumor shrinkage—was 46% for the bezuclastinib combination, nearly double the 26% rate observed in the sunitinib monotherapy arm. The company reported the combination was generally well-tolerated, with no new safety risks identified.
“These PEAK results have far surpassed our expectations and represent a potential paradigm shift for GIST patients,” said Andrew Robbins, President and CEO of Cogent Biosciences. “With a 50% reduction in the risk of disease progression or death, we believe the bezuclastinib and sunitinib combination is poised to become the new standard of care for treatment of second-line GIST patients.”
The findings are particularly significant as they mark the first positive Phase 3 trial in this specific GIST patient population in over 20 years, according to industry analysts. GIST is a rare, sarcoma-type cancer that originates in the gastrointestinal tract. While initial treatments are often effective, many patients develop resistance, creating a critical need for more durable second-line therapies.
The market’s explosive reaction underscores the potential commercial opportunity for bezuclastinib. Investors reacted with heavy volume, pushing the stock to levels not seen in the past year and validating the company's focus on precision therapies for genetically defined diseases. The strong data could position Cogent to capture a significant share of the GIST treatment market.
Based on the strength of the PEAK trial data, Cogent Biosciences announced plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the first half of 2026. The company also intends to present the full, detailed results at an upcoming scientific medical conference.
Prior to Monday's announcement, Wall Street analysts had set a consensus 12-month price target of $23.25 on the stock. The successful outcome of the Phase 3 trial is likely to trigger a wave of revised ratings and higher price targets as the company moves from a clinical-stage to a potential commercial-stage entity.