Shares of Cogent Biosciences Inc. (NASDAQ:COGT) climbed 10% on Monday following the release of highly promising top-line data from its SUMMIT trial, evaluating bezuclastinib in patients with non-advanced systemic mastocytosis (NonAdvSM).
According to the company, the experimental therapy achieved statistically significant results across all primary and key secondary endpoints. At week 24, patients receiving bezuclastinib experienced a notable improvement in total symptom scores, with a placebo-adjusted mean difference of 8.91 points (−24.3 vs. −15.4; p = 0.0002).
One of the most striking findings was the drug’s effect on mast cell burden: 87.4% of treated participants saw a ≥50% reduction in serum tryptase, a key biomarker, compared to none in the placebo group. The safety and tolerability profile also supported the drug’s long-term use, according to trial data.
With these encouraging results in hand, Cogent intends to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) by the end of 2025.
Beyond SUMMIT, the company expects to release pivotal data from two other late-stage programs—PEAK, focused on gastrointestinal stromal tumors (GIST), and APEX, targeting advanced systemic mastocytosis—by the second half of next year.
Adverse events reported in the trial were generally mild. Common side effects included hair color changes (69.5% vs. 5.0%), altered taste (23.7% vs. 0%), nausea (22.0% vs. 13.3%), and elevated liver enzymes (22.0% vs. 6.6%), all occurring more frequently in the treatment group.
Cogent also emphasized its strong financial footing, with $237 million in cash on hand and access to an additional $350 million through a recently secured debt facility with SLR Capital Partners.
The company plans to present full trial data at a medical conference later this year.