Investing.com -- Cogent Biosciences Inc (NASDAQ:COGT) stock surged 12.6% in Monday premarket trading after the company announced positive top-line results from its registration-directed APEX Part 2 clinical trial for bezuclastinib in advanced systemic mastocytosis (AdvSM).
The trial demonstrated a 57% objective response rate per mIWG criteria and 80% per PPR criteria, with 89% of patients achieving significant reductions in bone marrow mast cells. The drug also showed a favorable safety profile, with no patients discontinuing due to treatment-related adverse events.
This marks the third positive pivotal trial result for bezuclastinib in 2025, following earlier successful trials in NonAdvSM and GIST patients. Based on these results, Cogent plans to submit a new drug application to the FDA during the first half of 2026.
"Bezuclastinib demonstrated the rapid, deep clinical activity we were expecting given its earlier clinical results," said Daniel J. DeAngelo, M.D., Ph.D., Chief of the Division of Leukemia at the Dana-Farber Cancer Institute. "What is most exciting about these data is the impressive safety and tolerability results with no discontinuations due to treatment-related adverse events and only infrequent dose modifications. With this profile, bezuclastinib will become an important treatment option for this patient population."
The trial included 81 AdvSM patients treated with 150 mg of bezuclastinib. The median time to achieve response was 2.0 months, with multiple patients achieving unconfirmed response criteria and remaining on study awaiting follow-up assessment.
The most common treatment-related adverse events included hair color change (30.9%), neutropenia (29.6%), altered taste (28.4%), and thrombocytopenia (24.7%). Only 14.8% of patients required dose reduction.
Stifel analyst Laura Prendergast maintained a Buy rating with a $40.00 price target, while Raymond James analyst Chris Raymond reiterated a Strong Buy rating with a $60.00 price target on the stock.
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