By Connor Hart

Shares of Cogent Biosciences were higher after the company disclosed what it called positive top-line results from a recent trial of its treatment for certain types of mastocytosis, a rare disorder in which mast cells build up in the body.

The stock climbed 20%, to $9.11, in premarket trading Monday. Through Thursday's close, shares have lost 10% of their value in the past year, though they are up nearly 60% in the past three months.

The biotechnology company before the opening bell said that its treatment, bezuclastinib, demonstrated clinically meaningful and statistically significant improvements across the primary and key secondary endpoints in a recent study, including patient-reported symptoms and objective measures of mast cell burden.

Based on the data, Cogent said it is on track to submit its first new drug application to the Food and Drug Administration for bezuclastinib to treat patients with non-advanced systemic mastocytosis by the end of the year.

"We have been eagerly awaiting this day and are thrilled to announce bezuclastinib's performance in the Summit trial, demonstrating clinically meaningful and statistically significant results across all trial endpoints," Chief Executive Andrew Robbins said. "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."

Cogent plans to present detailed results from the Summit trial at an upcoming medical meeting later this year, it said.

Write to Connor Hart at connor.hart@wsj.com

(END) Dow Jones Newswires

July 07, 2025 08:09 ET (12:09 GMT)

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