WALTHAM, Mass. - Cogent Biosciences, Inc. (NASDAQ:COGT), a biotech firm specializing in precision therapies for genetic diseases and currently valued at $982 million, has revealed encouraging clinical trial results for its drug bezuclastinib, designed to treat systemic mastocytosis. The findings were presented at the American Society of Hematology Annual Meeting in San Diego. According to InvestingPro data, the company's stock has shown remarkable strength this year, delivering a 51% return year-to-date.
The trial, known as SUMMIT, assessed the efficacy of bezuclastinib in patients with non-advanced systemic mastocytosis (NonAdvSM). Preliminary data from the Open Label Extension (OLE) part of the trial showed a 56% average improvement in Total (EPA:TTEF) Symptom Score (TSS) at 24 weeks, with 76% of patients experiencing at least a 50% reduction in TSS.
Additionally, a significant decrease in serum tryptase levels was observed, with 89% of patients showing more than a 50% reduction within four weeks of treatment. By the 24-week mark, 95% of participants with elevated baseline tryptase achieved levels below 20 ng/ml. These promising results have caught analysts' attention, with InvestingPro data showing analyst price targets ranging from $10 to $23, suggesting significant potential upside from current levels.
The safety profile of bezuclastinib was also highlighted, with most treatment-emergent adverse events being low-grade and reversible. The most common side effects reported were hair discoloration and transaminase elevations, with no severe treatment-related bleeding or cognitive impairment events.
In a further update, Cogent announced the completion of enrollment for SUMMIT Part 2 ahead of schedule, with 179 patients now part of the study. Top-line results are expected in July 2025. The rapid enrollment reflects the high demand and potential impact of this treatment for NonAdvSM patients.
The company is set to host an investor webcast today to discuss these developments further. This news is based on a press release statement from Cogent Biosciences.
Bezuclastinib is part of Cogent's broader effort to develop targeted therapies for serious genetic diseases. The company continues its research with a focus on mutations in various genes associated with different conditions.
In other recent news, Cogent Biosciences has been the focus of various financial analysts. Piper Sandler and Citi have maintained an Overweight and Buy rating respectively, with price targets of $23.00 and $15.00. Despite a recent sell-off, Piper Sandler has expressed confidence in the upcoming data from Cogent's bezuclastinib trials, SUMMIT and APEX, which are expected to provide a clearer picture of the drug's potential.
In contrast, Needham revised its stock price target for Cogent from $16.00 to $15.00, maintaining a Buy rating despite the change. This adjustment follows the company's third-quarter earnings and upcoming presentations at the American Society of Hematology meeting.
H.C. Wainwright also maintained its Buy rating and a $17.00 price target for Cogent, following the presentation of preclinical results for its drug candidate CGT6297. The company has introduced two new inhibitors, CGT6737 and CGT6297, to its developmental pipeline, which have shown potential in preclinical models for significant tumor growth inhibition and improved safety profiles.
Cogent has completed patient enrollment for its Phase 3 PEAK trial, which is evaluating bezuclastinib for the treatment of gastrointestinal stromal tumors. Results are expected by the end of 2025. Additionally, Cogent's SUMMIT trial for nonadvanced systemic mastocytosis is set to complete enrollment in early 2025, with results anticipated later that year. These are recent developments that investors may want to keep an eye on.
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