Full Press Release Details
SUMMIT data for bezuclastinib in NonAdvSM selected for two oral presentations which will describe its best-in-class potential
Novel JAK2 V617F mutant-selective inhibitor announced as Cogent’s newest preclinical program; on-track for IND in 2026
WALTHAM, Mass. and BOULDER, Colo., Nov. 03, 2025 (GLOBE NEWSWIRE) --Cogent Biosciences, Inc.(Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced three presentations featuring bezuclastinib, including two oral presentations in NonAdvanced Systemic Mastocytosis (NonAdvSM), at the 67thAnnual Meeting of the American Society of Hematology (ASH) being held December 6-9, 2025 in Orlando, FL. Cogent also announced today plans to describe its novel JAK2 V617F mutant-selective inhibitor as part of a poster presentation at the 2025 ASH annual meeting.
“On behalf of our clinical trial investigators, Cogent is honored to announce multiple presentations from the SUMMIT trial at this year’s annual ASH meeting, including two oral presentations which will highlight the exciting results that bezuclastinib demonstrated in NonAdvSM patients,” said Andrew Robbins, the company’s President and Chief Executive Officer. “These data support our conviction that based on bezuclastinib’s potential to fundamentally modify the disease in NonAdvSM patients, it has the potential to become the preferred standard of care in this patient population. In addition, at ASH we look forward to sharing preclinical data from our newest research program, a novel JAK2 V617F mutant-selective inhibitor which we believe has best-in-class potential based on its potency and selectivity.”
Bezuclastinib Oral Presentations
Efficacy and safety results from the primary analysis of the pivotal Summit trial: Bezuclastinib in adults with non-advanced systemic mastocytosis
Session Name:634. Myeloproliferative Syndromes: Clinical and Epidemiological: Expanding the Therapeutic and Prognostic Landscape in Myeloproliferative Neoplasms, Mastocytosis and Hypereosinophilic SyndromePresenter:Lindsay Rein, MD, Associate Professor of Medicine in the Division of Hematologic Malignancies and Cellular Therapy at Duke UniversitySession Date and Time:December 6, 2025, 9:30 AM - 11:00 AM ETPresentation Time:9:45 AM - 10:00 AM ETLocation: -Room - W414CD
The effect of bezuclastinib on the pathobiology of mastocytosis: Changes in BM mast cells, tryptase, and KIT p.D816V variant allele frequency from the pivotal Summit trial
Session Name:634. Myeloproliferative Syndromes: Clinical and Epidemiological: Drivers and Mast Cells and Blasts, Oh My! - Insights and Treatments for MPNs and Mastocytosis.Presenter:Dr. Tracy George, MD, President and Chief Scientific Officer at ARUP Laboratories, Professor of Pathology at the University of Utah School of MedicineSession Date and Time:December 8, 2025, 4:30 PM - 6:00 PM ETPresentation Time:5:00 PM - 5:15 PM ETLocation: -West Hall D2
Bezuclastinib Poster PresentationRelationship between KIT inhibition by bezuclastinib and effects on disease burden in mouse models of systemic mastocytosis
Session Name:631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster IIISession Date and Time:December 8, 2025, 6:00 PM - 8:00 PM ETLocation: -West Halls B3-B4
JAK2 Poster PresentationPreclinical characterization of a novel, wild-type-sparing, JAK2 V617F mutant-selective inhibitor
Session Name:631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster IISession Date and Time:December 7, 2025, 6:00 PM - 8:00 PM ETLocation:West Halls B3-B4
Full abstracts will be available for online viewing via the ASH Annual Meeting website:https://www.hematology.org/meetings/annual-meeting.
About Cogent Biosciences, Inc.Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. In addition to bezuclastinib, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases initially targeting mutations in FGFR2/3, ErbB2, PI3Kα, KRAS and JAK2. Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information atwww.cogentbio.com. Follow Cogent Biosciences on social media:X(formerly known as Twitter) andLinkedIn. Information that may be important to investors will be routinely posted on our website andX.
Forward Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: bezuclastinib’s best-in-class potential for patients with NonAdvSM; the potential for bezuclastinib to fundamentally modify the disease in NonAdvSM patients and to become the preferred standard of care for this patient population; the best-in-class potential for the company’s novel JAK2 V617F mutant-selective inhibitor and the company’s plans to submit an NDA in 2026 for this program. The use of words such as, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results, the rate of enrollment in our clinical trials and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts or milestones disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Cogent's most recent Quarterly Report on Form 10-Q filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.