Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GIST

Cogent Biosciences (Nasdaq: COGT) announced FDA acceptance of its NDA for bezuclastinib plus sunitinib in imatinib-treated GIST, with Priority Review and a PDUFA target date of November 30, 2026.

Rhea-AI Summary

Cogent Biosciences (Nasdaq: COGT) announced FDA acceptance of its NDA for bezuclastinib plus sunitinib in imatinib-treated GIST, with Priority Review and a PDUFA target date of November 30, 2026. The Phase 3 PEAK trial showed improved median PFS and higher ORR versus sunitinib alone, with a generally manageable safety profile and active U.S. expanded access programs.

Positive

• FDA accepted NDA for bezuclastinib+sunitinib in GIST with Priority Review
• PDUFA target action date set for November 30, 2026
• PEAK Phase 3: median PFS 16.5 vs 9.2 months; HR 0.50
• Objective response rate 46% vs 26% in imatinib-resistant GIST
• FDA reported no current plan for advisory committee or identified review issues
• Active U.S. expanded access programs for GIST and systemic mastocytosis

Negative

• Grade 3+ ALT/AST increased: 10.8% on combination vs 1.4% on sunitinib alone
• Treatment-related discontinuations: 7.4% on bezuclastinib combination vs 3.8% on sunitinib
• Overall survival data from PEAK trial remains immature

Argus May 28 session

+2.52% close to close Open Argus

Details

News Market Reaction – COGT

On May 28, the day this news came out, COGT closed 2.52% above the previous close.

Data tracked by StockTitan Argus for the May 28 session.

Market Context

This announcement confirms FDA acceptance and Priority Review of bezuclastinib plus sunitinib in GIS...

Analysis

This announcement confirms FDA acceptance and Priority Review of bezuclastinib plus sunitinib in GIST, anchored by PEAK data showing mPFS of 16.5 vs 9.2 months and a hazard ratio of 0.50 with p<0.0001. The November 30, 2026 PDUFA date adds a clear regulatory milestone. Historical clinical news has produced mixed stock reactions, so investors may monitor upcoming ASCO presentations, evolving safety details, and further regulatory steps across GIST and systemic mastocytosis programs.

Key Figures

Median PFS (combo): 16.5 months Median PFS (control): 9.2 months Hazard ratio: HR = 0.50 (95% CI: 0.39–0.65) +5 more

Median PFS (combo)

16.5 months

Bezuclastinib + sunitinib in PEAK Phase 3 GIST trial

Median PFS (control)

9.2 months

Sunitinib monotherapy arm in PEAK Phase 3

Hazard ratio

HR = 0.50 (95% CI: 0.39–0.65)

Risk of progression or death vs sunitinib alone

P-value

p<0.0001

Primary endpoint of PFS in PEAK Phase 3

ORR (combo)

46%

Objective response rate in imatinib‑resistant GIST

ORR (control)

26%

Objective response rate with sunitinib monotherapy

Discontinuations (combo)

7.4%

Patients stopping treatment due to treatment‑related AEs

GIST PDUFA date

November 30, 2026

FDA target action date for GIST NDA with Priority Review

Previous Clinical trial Reports

5 past events · Latest: Apr 21

Same Type 5 events

1. Apr 21

   ASCO oral selection

   24h Move

   -0.7%

   Positive Phase 3 PEAK GIST data selected for ASCO oral presentation.

2. Apr 01

   GIST NDA submission

   24h Move

   -8.4%

   NDA submitted for bezuclastinib in imatinib‑resistant GIST under RTOR.

3. Mar 16

   NonAdvSM NDA accepted

   24h Move

   +5.0%

   FDA accepted bezuclastinib NDA in NonAdvanced SM with set PDUFA date.

4. Jan 20

   RTOR NDA plan

   24h Move

   +2.5%

   FDA agreed to RTOR-based NDA for GIST; strong PEAK efficacy metrics cited.

5. Dec 30

   NonAdvSM NDA filing

   24h Move

   -2.1%

   NDA filed for NonAdvanced SM based on positive SUMMIT trial results.

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

Key Terms

new drug application, priority review, breakthrough therapy designation, real-time oncology review, +4 more

8 terms

new drug application regulatory

"announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA)"

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.

priority review regulatory

"The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act"

Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.

breakthrough therapy designation regulatory

"builds upon previous assignment of Breakthrough Therapy Designation and Real-Time Oncology Review"

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

real-time oncology review regulatory

"builds upon previous assignment of Breakthrough Therapy Designation and Real-Time Oncology Review"

A regulatory process in which reviewers assess clinical data and application materials for a cancer therapy as they are submitted, instead of waiting for a complete package. By allowing questions to be answered and issues resolved during the submission rather than afterward, it can speed up decisions and reduce surprise delays. For investors, that means greater predictability around potential approvals or setbacks and a faster path to a drug reaching the market, similar to editing a book chapter-by-chapter rather than after the whole manuscript is finished.

pdufa regulatory

"and assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2026"

PDUFA is the Prescription Drug User Fee Act, the U.S. law under which drug companies pay fees that fund the FDA's review of new medicines. In company news the term usually appears as the PDUFA date, the target deadline by which the FDA aims to decide on a drug application; that date tells investors when to expect the approval or rejection decision for the product.

phase 3 medical

"following Phase 3 PEAK results; PDUFA date set for November 30, 2026"

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.

hazard ratio medical

"months (HR=0.50, CI: 0.39-0.65, p<0.0001) for bezuclastinib combination"

A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.

expanded access programs regulatory

"Cogent has established active Expanded Access Programs (EAPs) for U.S. patients with GIST or SM"

Expanded access programs let patients who are seriously ill and ineligible for clinical trials receive an investigational drug or therapy outside the trial system, often when no approved treatment exists. For investors, these programs matter because they can provide early real-world use that affects demand, public perception, regulatory scrutiny and safety data—like letting a handful of customers test a prototype product before full market approval, with both potential upside and risk.

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

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

NDA acceptance with Priority Review builds upon previous assignment of Breakthrough Therapy Designation and Real-Time Oncology Review following Phase 3 PEAK results; PDUFA date set for November 30, 2026 

Bezuclastinib combination is first treatment ever to demonstrate statistically significant advantage against an active comparator in GIST patients; median PFS of 16.5 months versus 9.2 months (HR=0.50, CI: 0.39-0.65, p<0.0001) for bezuclastinib combination compared to sunitinib alone

Full results from the Phase 3 PEAK trial to be shared in oral presentation at ASCO on Saturday, May 30, 2026

WALTHAM, Mass. and BOULDER, Colo., May 28, 2026 (GLOBE NEWSWIRE) --  Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib. The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2026. In addition, the FDA communicated that at this time, there is no plan to hold an advisory committee, nor have they identified any potential review issues.

“We are excited to announce that our bezuclastinib NDA for patients with GIST has been accepted for review by the FDA,” said Andrew Robbins, President and Chief Executive Officer of Cogent Biosciences. “We look forward to presenting the full, groundbreaking results from the PEAK trial at ASCO this weekend, and our preparations for expected bezuclastinib launches in both GIST and systemic mastocytosis later this year are well underway.”

PEAK Phase 3 Trial Results

As reported in November 2025, PEAK is a global, randomized Phase 3 clinical trial evaluating bezuclastinib in combination with sunitinib vs. sunitinib monotherapy in patients with imatinib-resistant or intolerant GIST. As of the cutoff date, September 30, 2025, the bezuclastinib combination demonstrated a substantial and highly statistically significant clinical benefit on the primary endpoint of PFS, reducing risk of disease progression or death compared to the current standard of care by 50% (hazard ratio of 0.50, 95% CI: 0.39 – 0.65). mPFS, as assessed by blinded independent central review, was 16.5 months for the bezuclastinib combination vs. 9.2 months for sunitinib monotherapy. Additionally, the bezuclastinib combination demonstrated an unprecedented ORR in imatinib-resistant patients, with 46% of patients treated with the bezuclastinib combination achieving an objective response compared to 26% of patients treated with sunitinib. Data for overall survival remains immature.

Safety Data

As of the data cutoff, the bezuclastinib combination was generally well tolerated, and no unique risks were observed with the novel combination when compared to the known safety profile of sunitinib. ​The most commonly reported Grade 3+ treatment emergent adverse events in either arm (bezuclastinib combination vs. sunitinib) included: Hypertension (29.4% vs. 27.4%), Neutropenia (15.2% vs. 15.4%), ALT/AST increased (10.8% vs. 1.4%), Anemia (9.3% vs. 4.8%) and Diarrhea (7.8% vs. 7.2%). 7.4% of patients on the bezuclastinib combination and 3.8% of patients on sunitinib monotherapy discontinued study treatment(s) due to treatment related adverse events. Hepatic adverse events were predominantly transient and manageable lab abnormalities; the majority of which were low grade, non-serious, reversible and asymptomatic. In the combination arm, ALT/AST elevations led to bezuclastinib dose reductions in 12.7% of patients with only 3 subjects (1.5%) discontinuing bezuclastinib for ALT/AST elevations. All Grade 3 ALT/AST elevations resolved, and no Grade 4 elevations were reported.

PEAK Phase 3 – ASCO 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

Bezuclastinib - Expanded Access Program

Working with the FDA, Cogent has established active Expanded Access Programs (EAPs) for U.S. patients with GIST or SM who meet disease-specific criteria and could benefit from treatment with bezuclastinib or the combination of bezuclastinib and sunitinib. For more information please visit: https://www.cogentbio.com/bezuclastinib-program-development/#our-expanded-access-policy

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 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: plans to present the full results from the PEAK trial at ASCO this weekend and the expected launch of bezuclastinib in both GIST and SM later this year. 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 Annual Report on Form 10-K, as supplemented by Quarterly Reports on Form 10-Q and other filings Cogent makes with the SEC from time to time . 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 a 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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What FDA decision did Cogent Biosciences (NASDAQ: COGT) announce on May 28, 2026 for bezuclastinib in GIST?

The FDA accepted Cogent Biosciences’ NDA for bezuclastinib plus sunitinib in previously imatinib-treated GIST, granting Priority Review. According to Cogent Biosciences, the application covers patients with imatinib-resistant or intolerant GIST and follows prior Breakthrough Therapy and Real-Time Oncology Review designations.

When is the PDUFA date for Cogent Biosciences’ bezuclastinib NDA in combination with sunitinib (COGT)?

The PDUFA target action date is November 30, 2026 for bezuclastinib plus sunitinib in GIST. According to Cogent Biosciences, the FDA currently does not plan an advisory committee and has not identified potential review issues at this time.

What were the key Phase 3 PEAK trial results for bezuclastinib plus sunitinib in GIST?

Bezuclastinib plus sunitinib achieved median PFS of 16.5 months versus 9.2 months for sunitinib alone. According to Cogent Biosciences, the hazard ratio was 0.50 (95% CI: 0.39–0.65; p<0.0001) and objective response rates were 46% versus 26% in imatinib-resistant patients.

How did the safety profile of bezuclastinib plus sunitinib compare to sunitinib alone in the PEAK trial?

The combination was generally described as well tolerated, without unique risks beyond sunitinib’s known profile. According to Cogent Biosciences, common Grade 3+ events included hypertension, neutropenia and elevated ALT/AST, with treatment-related discontinuations in 7.4% on combination versus 3.8% on sunitinib.

What expanded access options are available for bezuclastinib for GIST and systemic mastocytosis patients in the U.S.?

Cogent Biosciences has active expanded access programs for eligible U.S. patients with GIST or systemic mastocytosis. According to Cogent Biosciences, these programs can provide bezuclastinib or bezuclastinib plus sunitinib to patients meeting disease-specific criteria; details are available on the company’s website.

When and where will Cogent Biosciences present full Phase 3 PEAK data for bezuclastinib in GIST (COGT)?

Full PEAK Phase 3 results will be presented in an oral session at ASCO on May 30, 2026. According to Cogent Biosciences, the talk is scheduled in the Sarcoma Oral Abstract Session at McCormick Place Convention Center in Chicago.