Cogent Biosciences: Riding High on Pivotal Trial Data

Cogent Biosciences shares have risen 55% since it presented pivotal trial data for bezuclastinib in non-advanced systemic mastocytosis, outperforming Sanofi's similar-class asset. The data showed bezuclastinib was effective in treating the condition and had a favorable safety profile. Cogent is a precision medicine company focusing on developing therapies for hematologic malignancies and immune-oncology indications.

Cogent Biosciences Inc. (NASDAQ: COGT), a clinical-stage biotechnology company specializing in precision therapies, has seen its shares rise by 55% since presenting pivotal trial data for bezuclastinib in non-advanced systemic mastocytosis. The trial results, which were announced on June 11, 2025, demonstrated the effectiveness of bezuclastinib in treating the condition and showcased a favorable safety profile [1]. This significant performance has outpaced Sanofi's similar-class asset.

Bezuclastinib, a selective kinase inhibitor, achieved statistical significance across all primary and secondary endpoints in the SUMMIT trial. The drug showed a superior mean change in total symptom score of -24.3 points versus -15.4 for placebo (p=0.0002), with 87.4% of treated patients achieving ≥50% reduction in serum tryptase compared to 0% for placebo. The drug also exhibited a favorable safety profile with mostly low-grade adverse events [1].

Cogent Biosciences is focusing on developing therapies for hematologic malignancies and immune-oncology indications, aligning with the growing demand for precision medicine. The company's strong financial position, supported by a $400 million non-dilutive debt financing facility and a $230 million public offering, positions it well for upcoming clinical milestones and the expected commercial launch of bezuclastinib in 2026 [2].

Key upcoming catalysts include the pivotal trial results from the PEAK (GIST) and APEX (AdvSM) trials in the second half of 2025, followed by the company's first New Drug Application (NDA) submission by the end of the year. The company is also preparing for the presentation of its results at the Citi Biopharma Conference on September 3, 2025 [3].

References:
[1] https://www.stocktitan.net/news/COGT/
[2] https://www.stocktitan.net/news/COGT/
[3] https://www.stocktitan.net/news/COGT/