Cogent Shares Climb On Positive Bezuclastinib Trial Results In NonAdvSM, Plan To Submit NDA To FDA

(RTTNews) - Shares of Cogent Biosciences, Inc. (COGT) were gaining around 27 percent in the pre-market activity on the Nasdaq after the company announced Monday positive top-line results from the SUMMIT clinical trial of bezuclastinib in patients with non-advanced systemic mastocytosis or NonAdvSM.

Based on these data, the biotechnology company said it is on track to submit its first new drug application or NDA to the U.S. Food and Drug Administration for bezuclastinib in NonAdvSM by the end of 2025.

The results from the registration-directed Part 2 of the SUMMIT trial demonstrated clinically meaningful and highly statistically significant improvements across the primary and all key secondary endpoints, including patient-reported symptoms and objective measures of mast cell burden.

The SUMMIT trial, which was designed to assess the clinical benefit of bezuclastinib versus placebo, achieved its primary endpoint with a highly statistically significant difference in the mean change in total symptom score or TSS at 24 weeks. TSS was assessed by the Mastocytosis Symptom Severity Daily Diary or MS2D2.

In addition, the SUMMIT trial demonstrated highly statistically significant benefit across all key secondary endpoints, including reduction of serum tryptase on which 87.4% of bezuclastinib-treated patients had 50% reduction, compared to no patients in the control arm.

The majority of treatment emergent adverse events or TEAEs were of low grade. The most frequent TEAEs reported on bezuclastinib treatment were hair color change, altered taste, nausea and ALT/AST elevations.

The company further announced strong financial position with $237 million current cash balance and access up to an additional $350 million through recently announced debt facility with SLR Capital Partners.

Andrew Robbins, Cogents President and CEO, said, "We have been eagerly awaiting this day and are thrilled to announce bezuclastinibs performance in the SUMMIT trial, demonstrating clinically meaningful and statistically significant results across all trial endpoints. Our team is already at work on our first New Drug Application for bezuclastinib that we expect to file with the FDA later this year. We are committed to providing bezuclastinib access to the thousands of patients with Non-Advanced Systemic Mastocytosis as quickly as possible, including through our recently announced Bezuclastinib Expanded Access Program."

The company noted that complete analysis of the full SUMMIT Part 2 data are ongoing, and Cogent plans to present detailed results at an upcoming major medical conference later this year.

Cogent remains on track to provide top-line results from both PEAK, a Phase 3 trial of bezuclastinib in combination with sunitinib in patients with gastrointestinal stromal tumors or GIST, and APEX, a registration-directed trial of bezuclastinib in advanced systemic mastocytosis or AdvSM patients, during the second half of 2025.

In the pre-market activity on the Nasdaq, Cogent Biosciences were trading at $9.59, up 26.52%.

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