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

Rhea-AI Summary

Cogent Biosciences (Nasdaq: COGT) announced that positive Phase 3 PEAK trial results for bezuclastinib plus sunitinib in prior‑imatinib GIST will be presented orally at the 2026 ASCO Annual Meeting in Chicago on May 30, 2026.

Top‑line results were reported in November 2025 and an NDA was submitted under the RTOR program in March 2026. Cogent plans to initiate a Phase 2 trial this quarter for first‑line exon 9 GIST patients naive or recently started on imatinib.

Positive

• Positive Phase 3 PEAK trial for bezuclastinib+sunitinib in prior‑imatinib GIST
• NDA submitted under Real‑Time Oncology Review in March 2026
• ASCO oral presentation scheduled May 30, 2026 (abstract #11500)
• Top‑line PEAK results publicly reported November 2025
• Planned Phase 2 initiation this quarter for first‑line exon 9 GIST patients

Negative

• Regulatory approval pending—NDA under review, no approval yet
• PEAK trial focused on post‑imatinib patients, limiting indication to previously treated GIST

News Market Reaction – COGT

-0.73%

-0.73% Session close to close

In the Apr 21 session, COGT declined 0.73%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights full Phase 3 PEAK results for bezuclastinib plus sunitinib in GIST bein...

Analysis

This announcement highlights full Phase 3 PEAK results for bezuclastinib plus sunitinib in GIST being featured as an oral presentation at ASCO 2026, reinforcing earlier data that underpinned the GIST NDA. It also signals expansion into a Phase 2 first-line exon 9 GIST trial. In context of prior SUMMIT and APEX successes and a PDUFA date of December 30, 2026, investors may track upcoming detailed ASCO data, regulatory milestones, and continued operating losses of $328.9 million in 2025.

Key Figures

Risk reduction: 50% reduction in risk Median PFS: 16.5 vs 9.2 months ORR: 46% vs 26% +5 more

8 metrics

Risk reduction 50% reduction in risk PEAK Phase 3 GIST trial vs sunitinib

Median PFS 16.5 vs 9.2 months PEAK Phase 3 bezuclastinib + sunitinib vs sunitinib

ORR 46% vs 26% Objective response rate in PEAK Phase 3, combo vs sunitinib

PDUFA date December 30, 2026 NonAdvanced SM bezuclastinib NDA

Cash balance $900.8 million Year-end 2025 cash, cash equivalents and marketable securities

R&D expense $269.8 million Full-year 2025 research and development expenses

Net loss $328.9 million Full-year 2025 net loss

Short interest 10.88% Short percent of float, days to cover 7.1

Previous Clinical trial Reports

5 past events · Latest: Apr 01 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Apr 01	GIST NDA submission	Positive	-8.4%	Submitted NDA to FDA for bezuclastinib in imatinib‑resistant GIST under RTOR.
Mar 16	NonAdvSM NDA accepted	Positive	+5.0%	FDA accepted NDA for bezuclastinib in NonAdvanced SM with set PDUFA date.
Jan 20	RTOR NDA plan	Positive	+2.5%	Announced FDA agreement for RTOR NDA for bezuclastinib + sunitinib in GIST.
Dec 30	NonAdvSM NDA filed	Positive	-2.1%	Filed NDA for bezuclastinib in NonAdvanced SM after positive SUMMIT data.
Nov 10	PEAK Phase 3 results	Positive	+119.0%	Reported strongly positive PEAK Phase 3 results in imatinib‑resistant GIST.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Across 5 recent clinical-trial announcements, all were positive, with 3 followed by gains and 2 by declines, showing mixed price follow-through on good data.

Recent Company History

Over the past several months, Cogent has repeatedly advanced bezuclastinib across GIST and systemic mastocytosis. Positive PEAK Phase 3 data in GIST and SUMMIT/APEX results in mastocytosis supported multiple NDA submissions and FDA acceptance, including a PDUFA date set for December 30, 2026. Clinical-trial headlines have produced both sharp rallies, such as the 119.03% move on Nov 10, 2025, and occasional selloffs. Today’s ASCO oral presentation fits into this ongoing transition from pivotal data to regulatory review and earlier-line development in GIST.

Key Terms

phase 3, gastrointestinal stromal tumors (gist), new drug application, real-time oncology review (rtor), +2 more

6 terms

phase 3 medical

"results from the Phase 3 PEAK trial have been selected for oral presentation"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

gastrointestinal stromal tumors (gist) medical

"in patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment"

Gastrointestinal stromal tumors (GIST) are a type of cancer that arises in the walls of the stomach or intestines, growing from cells that control gut movement. Investors care because GIST often requires targeted medicines or surgery, so successful drug trials, approvals, or new treatment options can directly affect a drugmaker’s sales prospects and a treatment’s market size—similar to how a successful product launch can change a company’s future revenue.

new drug application regulatory

"the New Drug Application was submitted under the Real-Time Oncology Review"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

real-time oncology review (rtor) regulatory

"New Drug Application was submitted under the Real-Time Oncology Review (RTOR) program"

Real-Time Oncology Review (RTOR) is a regulatory program that lets drug regulators review key clinical data as it becomes available instead of waiting for a finished application, so the assessment can proceed in parallel with the company's final submission. For investors, RTOR matters because it can shorten the time between final data and a decision—like letting an inspector check a building while it's being finished—reducing approval uncertainty and potentially accelerating a therapy’s market entry and revenue timing.

phase 2 medical

"on track this quarter to initiate a Phase 2 trial investigating the benefit"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

exon 9 mutations medical

"first-line GIST patients with exon 9 mutations who are naive to, or recently initiated"

Exon 9 mutations are changes in the ninth coded segment of a gene’s instructions that can alter the shape or function of the resulting protein. Like swapping or misprinting a step in a recipe, such changes can cause or influence disease, affect how patients respond to drugs, or determine whether a diagnostic test flags a condition—factors that can change a biotech company’s clinical prospects and commercial value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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: 11500
Presenter: 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 School
Session 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 - Sarcoma 
Location: 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 and X.

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

FAQ

What will Cogent (COGT) present at ASCO 2026 about the Phase 3 PEAK trial?

Cogent will present primary Phase 3 PEAK results for bezuclastinib+sunitinib versus sunitinib on May 30, 2026. According to Cogent, the oral session will summarize topline efficacy and safety data from patients previously treated with imatinib.

When was the PEAK trial top‑line data reported and what regulatory step followed for COGT?

Top‑line PEAK results were reported in November 2025, followed by an NDA submission in March 2026. According to Cogent, the NDA was submitted under the FDA Real‑Time Oncology Review program.

How could the PEAK trial oral presentation on May 30, 2026 affect COGT shares?

The ASCO oral presentation could raise visibility and investor interest in COGT near term. According to Cogent, the presentation will highlight positive Phase 3 results and the company’s recent NDA submission under RTOR.

What is the scope of the submitted NDA for bezuclastinib from COGT?

The NDA covers bezuclastinib combined with sunitinib for GIST patients who had prior imatinib. According to Cogent, the submission reflects positive Phase 3 PEAK topline data reported in November 2025.

What new clinical trial will Cogent (COGT) start after the PEAK results?

Cogent plans to initiate a Phase 2 trial this quarter for first‑line GIST patients with exon 9 mutations. According to Cogent, the trial will enroll patients naive to or recently started on imatinib.

Where and when is Cogent’s PEAK oral abstract presentation scheduled at ASCO 2026?

The oral presentation is scheduled May 30, 2026, 3:00 PM–6:00 PM CT in South Building, Grand Ballroom S100bc at McCormick Place, Chicago. According to Cogent, the abstract number is 11500 and presenter is Andrew J. Wagner, M.D., Ph.D.