Cogent Biosciences Reports Positive FDA Outcome

Cogent Biosciences, Inc. (NASDAQ: COGT) has announced a positive outcome from its recent discussions with the U.S. Food and Drug Administration (FDA) regarding the use of the Mastocytosis Symptom Severity Daily Diary (MS2D2) in the Summit trial for nonadvanced systemic mastocytosis patients. The company's novel patient-reported outcome measure, MS2D2, aims to measure the severity of mastocytosis symptoms through a questionnaire completed by patients.

The company remains on track to complete enrollment in Summit part 2 by the second quarter of 2025, with top-line results expected by the end of 2025. Additionally, enrollment in the Apex study for patients with advanced systemic mastocytosis is expected to be completed by the end of 2024, with top-line results anticipated by mid-2025.

In terms of the Bezuclastinib clinical development, Cogent Biosciences is progressing with enrollment in the phase 3 registration-enabling Peak study, which includes approximately 388 second-line, post-imatinib patients with gastrointestinal stromal tumors (GIST). Rapid enrollment in the Peak study is expected to be completed in the third quarter of 2024, with top-line results expected by the end of 2025.

The company's most advanced clinical program, Bezuclastinib, is a selective tyrosine kinase inhibitor designed to inhibit the KIT D816V mutation, which drives systemic mastocytosis, and other mutations in KIT exon 17. This mutation is responsible for the unchecked proliferation of mast cells, leading to systemic mastocytosis, a serious disease. Cogent Biosciences is also developing a portfolio of novel targeted therapies targeting mutations in FGFR2, ERBB2, and PI3Kα.

Overall, the company continues to focus on developing precision therapies for genetically defined diseases, with a particular emphasis on advancing its clinical programs and achieving key enrollment and reporting milestones.

The market has reacted to these announcements by moving the company's shares 5.8% to a price of $8.57. If you want to know more, read the company's complete 8-K report here.

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