COGT Stock Skyrockets 120% in a Month: Here's What You Need to Know

Core Insights - Cogent Biosciences (COGT) shares have surged 120.3% in one month, primarily due to positive data from a late-stage study of its investigational therapy combining bezuclastinib and sunitinib for second-line gastrointestinal stromal tumors (GIST) patients [1][5] - The phase III PEAK study demonstrated a 50% reduction in the risk of disease progression or death, with a median progression-free survival (PFS) of 16.5 months compared to 9.2 months for sunitinib monotherapy [2][5] - The combination therapy achieved a 46% objective response rate (ORR), significantly higher than the 26% ORR for sunitinib alone, indicating superior antitumor activity [3][5] - COGT plans to submit a regulatory filing to the FDA for the bezuclastinib/sunitinib combination in the first half of 2026, aiming to establish it as the new standard of care for GIST [7] Study Data Summary - The bezuclastinib/sunitinib combination showed a statistically significant clinical benefit on the primary endpoint of PFS, with a 50% reduction in disease progression risk [2] - The treatment was well tolerated, with no new safety risks identified compared to sunitinib's established profile, and most treatment-related adverse events were mild to moderate [6] Pipeline Overview - Bezuclastinib is the lead candidate for Cogent Biosciences, with ongoing evaluations for two systemic mastocytosis (SM) indications in separate phase III studies [8] - Positive top-line data from a late-stage study for non-advanced SM patients was reported, with plans to submit a new drug application to the FDA by the end of 2025 [9][11] - The company is also conducting a pivotal phase III study for advanced SM, with top-line results expected in December 2025 [12] Market Performance - Year-to-date, COGT shares have increased by 347.9%, significantly outperforming the industry growth of 15.8% [4]