Cogent Biosciences Announces Multiple Presentations at the 67th Annual American Society of Hematology (ASH) Meeting

Rhea-AI Summary

Cogent Biosciences (Nasdaq: COGT) announced three ASH 2025 presentations highlighting bezuclastinib and a preclinical JAK2 V617F mutant-selective inhibitor.

Key items: two oral presentations from the pivotal SUMMIT trial in Non-Advanced Systemic Mastocytosis (Dec 6 and Dec 8, 2025), a poster on bezuclastinib disease-burden effects (Dec 8, 2025), and a poster describing a novel JAK2 V617F mutant-selective inhibitor with the program stated to be on-track for an IND in 2026.

Positive

• Two oral SUMMIT presentations at ASH on Dec 6 and Dec 8, 2025
• Pivotal SUMMIT trial primary analysis of efficacy and safety presented
• Bezuclastinib linked to changes in BM mast cells, tryptase, KIT D816V VAF
• JAK2 V617F mutant-selective program described as on-track for IND in 2026

Negative

• None.

Insights

Hematology clinical strategist

Multiple oral presentations of pivotal SUMMIT results and a preclinical JAK2 program signal clinically relevant progress and near‑term readouts.

Cogent Biosciences will present primary analysis efficacy and safety data from the pivotal SUMMIT trial of bezuclastinib in NonAdvanced Systemic Mastocytosis at the December 6-9, 2025 ASH meeting, including two oral talks and a poster on biological effects. Oral selection for a pivotal primary analysis typically reflects meaningful dataset maturity and peer interest, which can increase clinical visibility and investigator adoption if results are favorable.

The company also plans a poster describing a novel, wild-type‑sparing JAK2 V617F mutant‑selective inhibitor and states the program is on track for an IND in 2026. These disclosures show parallel clinical and preclinical progress; the near-term dependency is the content of the disclosed primary analysis and any IND-enabling data. Key risks include unknown magnitude and durability of efficacy, safety findings, and regulatory review outcomes, none of which are detailed here.

Watch the published ASH abstracts and the oral presentations on December 6, 2025 and December 8, 2025 for exact efficacy, safety, and biomarker changes (KIT p.D816V VAF, tryptase, bone marrow mast cell counts). Also monitor confirmation of the IND timeline in 2026 and any subsequent regulatory filings; these items will clarify whether the announcements materially alter clinical or commercial prospects over the next 6–18 months.

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 67^th Annual 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 Syndrome 
Presenter: Lindsay Rein, MD, Associate Professor of Medicine in the Division of Hematologic Malignancies and Cellular Therapy at Duke University 
Session Date and Time: December 6, 2025, 9:30 AM - 11:00 AM ET 
Presentation Time: 9:45 AM - 10:00 AM ET 
Location: - 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 Medicine  
Session Date and Time: December 8, 2025, 4:30 PM - 6:00 PM ET 
Presentation Time: 5:00 PM - 5:15 PM ET 
Location: - West Hall D2

Bezuclastinib Poster Presentation
Relationship 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 III 
Session Date and Time: December 8, 2025, 6:00 PM - 8:00 PM ET 
Location: - West Halls B3-B4

JAK2 Poster Presentation
Preclinical 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 II 
Session Date and Time: December 7, 2025, 6:00 PM - 8:00 PM ET 
Location: 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 at www.cogentbio.com. Follow Cogent Biosciences on social media: X (formerly known as Twitter) and LinkedIn. Information that may be important to investors will be routinely posted on our website and X. 

Forward Looking Statements
This 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.

Contact:
Christi Waarich
Senior Director, Investor Relations
christi.waarich@cogentbio.com
617-830-1653

FAQ

When will Cogent present bezuclastinib SUMMIT data at ASH 2025 (COGT)?

Cogent will present SUMMIT data in two oral sessions on Dec 6, 2025 (9:45 AM ET) and Dec 8, 2025 (5:00 PM ET).

What aspects of bezuclastinib will Cogent (COGT) report at ASH 2025?

Presentations cover the pivotal SUMMIT primary efficacy and safety analysis and effects on bone marrow mast cells, tryptase, and KIT D816V VAF.

Is Cogent (COGT) presenting preclinical JAK2 V617F data at ASH 2025 and what is the timeline?

Yes; a poster will describe a novel JAK2 V617F mutant-selective inhibitor, with the program said to be on-track for an IND in 2026.

Where and when is the bezuclastinib poster session at ASH 2025?

The bezuclastinib poster is scheduled for Dec 8, 2025, 6:00–8:00 PM ET in West Halls B3-B4.

How can investors access full ASH 2025 abstracts for Cogent (COGT)?

Full abstracts will be available online via the ASH Annual Meeting website after they are posted.

What is bezuclastinib’s targeted mutation and disease focus for Cogent (COGT)?

Bezuclastinib is a selective kinase inhibitor targeting KIT D816V and exon 17 mutations, developed for systemic mastocytosis and KIT-driven tumors.