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Cogent Biosciences Announces Oral Presentation of Positive Phase 3 PEAK Trial in Gastrointestinal Stromal Tumors (GIST) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

Key Takeaway: Cogent Biosciences announced that results from its Phase 3 PEAK trial will be presented at the 2026 ASCO Annual Meeting. The trial demonstrated positive outcomes for bezuclastinib combined with sunitinib in GIST patients previously treated with imatinib. The company is also set to initiate a Phase 2 trial for first-line GIST patients with exon 9 mutations.
Price reaction · baseline $37 (2026-04-20 close) · hit after-hours · clean, no other COGT news in the window
day 0 close · peak
-0.7%

Market Sentiment Analysis

POSITIVE FACTORS

  • Positive results from the Phase 3 PEAK trial.
  • Oral presentation at a prestigious conference (ASCO).
  • New Drug Application submitted under RTOR program.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+38%
120-day peak, hindsight
Typical move
17.4%
average across 10 past catalysts
Cash runway
~30 mo
Minimal dilution risk
Lead asset
Bezuclastinib
Phase 2 · SSM

Full Press Release Details

WALTHAM, Mass. and BOULDER, Colo., April 21, 2026 (GLOBE NEWSWIRE) --Cogent Biosciences, Inc.(Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that the results from the Phase 3 PEAK trial have been selected for oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, IL, May 29-June 2, 2026. The presentation will feature data from the positive trial of bezuclastinib in combination with sunitinib in patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib. Top line results were reported in November 2025, and the New Drug Application was submitted under the Real-Time Oncology Review (RTOR) program in March 2026.

Oral Presentation Details

Abstract Title:Primary Results of the Phase 3 Peak Study of bezuclastinib + sunitinib vs sunitinib Monotherapy in Advanced Gastrointestinal Stromal Tumors (GIST)Abstract Number for Publication:11500Presenter:Andrew J. Wagner, M.D., Ph.D., Senior Physician, Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical SchoolSession Date and Time:May 30, 2026, 3:00 PM-6:00 PM CT (4:00 PM-7:00 PM ET)Session Title:Oral Abstract Session - SarcomaLocation:South Building, Floor 1, Grand Ballroom, S100bc - McCormick Place Convention Center, Chicago, IL
Cogent is on track this quarter to initiate a Phase 2 trial investigating the benefit of the bezuclastinib plus sunitinib combination for first-line GIST patients with exon 9 mutations who are naive to, or recently initiated treatment with, imatinib.
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, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in 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 andX.

Contact:Christi WaarichSenior Director, Investor Relationschristi.waarich@cogentbio.com617-830-1653

Frequently Asked Questions

What is the PEAK trial about?

The PEAK trial investigates the combination of bezuclastinib and sunitinib in GIST patients previously treated with imatinib.

When will the PEAK trial results be presented?

The results will be presented on May 30, 2026, at the ASCO Annual Meeting.

What is bezuclastinib?

Bezuclastinib is a selective tyrosine kinase inhibitor targeting the KIT D816V mutation and other KIT mutations.

What is the significance of the ASCO meeting?

The ASCO meeting is a prestigious event where significant oncology research findings are presented.

What future trials is Cogent planning?

Cogent plans to initiate a Phase 2 trial for first-line GIST patients with exon 9 mutations.

Last updated: Apr 21, 2026