Cogent Biosciences to Initiate New Drug Application (NDA) Submission for Bezuclastinib Under Real-Time Oncology Review (RTOR) 

Rhea-AI Summary

Cogent Biosciences (Nasdaq: COGT) announced FDA agreement to accept its NDA for bezuclastinib + sunitinib for imatinib‑resistant GIST under the Real‑Time Oncology Review (RTOR) program. The Phase 3 PEAK trial showed a 50% reduction in risk of progression or death (HR 0.50, 95% CI 0.39–0.65), mPFS 16.5 months vs 9.2 months, and ORR 46% vs 26% versus sunitinib. Cogent will initiate RTOR immediately and expects to complete the NDA submission in April 2026. Full PEAK results will be presented in H1 2026 and a Phase 2 first‑line exon 9 trial is planned for mid‑2026.

Positive

• FDA agreed to accept NDA for bezuclastinib combination under RTOR
• PEAK trial: mPFS 16.5 months vs 9.2 months (HR 0.50, 95% CI 0.39–0.65)
• PEAK trial: ORR 46% with combination vs 26% with sunitinib
• NDA submission completion targeted for April 2026 and RTOR begun immediately

Negative

• Overall survival data from PEAK remain immature
• Safety described as generally well tolerated but long‑term combination risks remain to be fully characterized

News Market Reaction

+2.47%

1 alert

+2.47% News Effect

On the day this news was published, COGT gained 2.47%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

mPFS combo arm: 16.5 months mPFS control arm: 9.2 months Hazard ratio: 0.50 (95% CI: 0.39–0.65) +5 more

8 metrics

mPFS combo arm 16.5 months Bezuclastinib + sunitinib in PEAK GIST trial

mPFS control arm 9.2 months Sunitinib monotherapy in PEAK GIST trial

Hazard ratio 0.50 (95% CI: 0.39–0.65) Risk of progression or death vs. sunitinib

ORR combo arm 46% Objective response rate in imatinib-resistant GIST

ORR control arm 26% Objective response rate with sunitinib monotherapy

Risk reduction 50% Reduction in progression or death vs. standard of care

NDA completion target April 2026 Expected completion of PEAK NDA submission under RTOR

Phase 2 start Mid-2026 Planned first-line GIST exon 9 Phase 2 trial initiation

Market Reality Check

Price: $37.08 Vol: Volume 2,306,078 is near ...

normal vol

$37.08 Last Close

Volume Volume 2,306,078 is near the 20-day average of 2,381,037 (relative volume 0.97x). normal

Technical Price $38.94 is trading above the 200-day MA at $16.46 and 10.95% below the 52-week high.

Peers on Argus

COGT was down 0.79% while close peers showed mixed moves: CLDX -0.5%, MESO -0.63...

COGT was down 0.79% while close peers showed mixed moves: CLDX -0.5%, MESO -0.63%, AUPH +0.47%, DYN +0.27%, IMCR +1.06%, indicating stock-specific trading rather than a broad biotech move.

Common Catalyst Another peer, DYN, also had clinical trial–related news, but there was only one such peer headline, suggesting no broad shared catalyst.

Historical Context

5 past events · Latest: Jan 12 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 12	Milestone outlook	Positive	-1.7%	Outlined 2026 NDA timelines, trial data presentations, and cash position.
Jan 06	Conference appearance	Neutral	+1.5%	Announced CEO presentation at J.P. Morgan Healthcare Conference.
Dec 30	NDA submission	Positive	-2.1%	Filed NDA for bezuclastinib in NonAdvanced Systemic Mastocytosis.
Dec 08	Clinical data AdvSM	Positive	+4.0%	Reported positive APEX Part 2 results in advanced systemic mastocytosis.
Nov 14	Conference participation	Neutral	-0.9%	Announced participation in Jefferies Global Healthcare Conference.

Pattern Detected

Recent positive clinical and regulatory milestones have often seen mixed or even negative next‑day reactions, with only one of three clearly positive items aligning with an immediate price gain.

Recent Company History

Over the last few months, Cogent highlighted multiple milestones for bezuclastinib. Positive AdvSM APEX data on Dec 8, 2025 coincided with a 3.95% gain, while the NonAdvSM NDA submission on Dec 30, 2025 and broader 2026 milestone update on Jan 12, 2026 both saw modest declines. Conference-related announcements in November 2025 and early January 2026 produced small, mixed moves. Today’s GIST-focused NDA/RTOR update follows prior PEAK data that had already been disclosed and financed against via offerings.

Market Pulse Summary

This announcement advances bezuclastinib in GIST from pivotal PEAK results to FDA review under the R...

Analysis

This announcement advances bezuclastinib in GIST from pivotal PEAK results to FDA review under the RTOR pathway, with NDA completion targeted for April 2026. The data reiterate a 50% reduction in progression or death, mPFS of 16.5 vs 9.2 months, and ORR of 46% vs 26%. In context of prior NonAdvSM and AdvSM progress, key watchpoints include full PEAK data in 1H 2026 and execution on the planned first-line GIST Phase 2 trial.

Key Terms

mPFS, overall response rate (ORR), progression free survival (PFS), hazard ratio, +4 more

8 terms

mPFS medical

"demonstrating mPFS of 16.5 months and ORR of 46% in patients"

The MPFS (Medicare Physician Fee Schedule) is the official price list Medicare uses to set how much it will pay doctors and other clinicians for specific medical services. Think of it like a menu of reimbursement rates: changes to the MPFS raise or lower what providers earn for each procedure, which can directly affect health-care providers’ revenue, profit margins and the valuations of companies that rely heavily on Medicare payments — information investors use to judge financial risk and growth prospects.

overall response rate (ORR) medical

"an unprecedented overall response rate (ORR) in imatinib-resistant patients"

Overall response rate (ORR) is the percentage of trial participants whose disease measurably improves—typically tumor shrinkage or disappearance—according to predefined medical criteria. Investors watch ORR because it provides an early, concrete signal of a therapy’s effectiveness and commercial potential, similar to seeing what share of products in a test batch actually work before deciding to back wider production.

progression free survival (PFS) medical

"clinical benefit on the primary endpoint of progression free survival (PFS)"

Progression free survival (PFS) is the amount of time after a treatment starts during which a patient’s disease does not get worse. Investors watch PFS because it’s a commonly reported measure in clinical trials that can indicate a drug’s effectiveness earlier than overall survival, much like measuring how long a dam holds before leaks reappear; stronger PFS results can speed regulatory decisions and affect a drug’s commercial prospects.

hazard ratio medical

"by 50% (hazard ratio of 0.50, 95% CI: 0.39 – 0.65)"

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.

overall survival medical

"At the time of this analysis, data for overall survival remains immature."

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

Real-Time Oncology Review (RTOR) regulatory

"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.

New Drug Application (NDA) regulatory

"has agreed to accept its New Drug Application (NDA) for bezuclastinib"

A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.

Phase 2 trial medical

"expects to initiate in mid-2026 a Phase 2 trial investigating the benefit"

A phase 2 trial is an intermediate-stage clinical study that tests whether a new treatment works and is reasonably safe in a group of patients who have the condition it targets. Think of it as a field test of a prototype product: it checks real-world effectiveness and side effects on a modest number of users to decide whether the treatment should move to larger, definitive testing. Investors watch phase 2 results because positive outcomes can sharply increase the likelihood of regulatory approval and future sales, while failures often halt development.

AI-generated analysis. Not financial advice.

-  PEAK trial first ever study to demonstrate statistical significance over an active comparator in GIST patients, with bezuclastinib plus sunitinib combination demonstrating mPFS of 16.5 months and ORR of 46% in patients who had received prior treatment with imatinib 

-  Cogent is expected to initiate the RTOR process immediately; completion of the PEAK NDA submission expected in April 2026

WALTHAM, Mass. and BOULDER, Colo., Jan. 20, 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 agreed to accept 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 under the Real-Time Oncology Review (RTOR) program. 

“This milestone reflects the FDA’s recognition of the significant unmet need facing patients with imatinib resistant GIST,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “Based on positive results from the PEAK trial, the bezuclastinib combination has the potential to be the first new approval in this patient population in over 20 years. We look forward to the continued, close collaboration with the FDA as we advance bezuclastinib toward commercialization.” 

As announced in November 2025, the bezuclastinib combination in the PEAK trial demonstrated a substantial and highly statistically significant clinical benefit on the primary endpoint of progression free survival (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 overall response rate (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. At the time of this analysis, data for overall survival remains immature. 

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 FDA’s RTOR program allows an applicant to pre-submit components of its NDA to allow the FDA to review clinical trial data before the complete filing is submitted and aims to provide a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. Cogent is expected to initiate the RTOR process immediately with completion of the NDA submission expected in April 2026. 

Full results from the PEAK trial will be presented at a major medical meeting during the first half of 2026. Additionally, Cogent expects to initiate in mid-2026 a Phase 2 trial investigating the benefit of the bezuclastinib 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 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: the company’s expectation that it will initiate the RTOR process immediately and complete its NDA submission for bezuclastinib in GIST in April 2026; the potential for the bezuclastinib combination to be the first approved therapy for GIST patients in over 20 years; plans to present the full results from the PEAK trial at a major medical meeting during the first half of 2026 and the expectation to initiate in mid-2026 a Phase 2 trial investigating the benefit of the bezuclastinib combination for first-line GIST patients with exon 9 mutations who are naive to, or recently initiated treatment with, imatinib. 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 and/or 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

What did Cogent (COGT) announce on January 20, 2026 about bezuclastinib?

Cogent said the FDA agreed to accept its NDA for bezuclastinib plus sunitinib under RTOR and the company expects to complete the submission in April 2026.

What were the PEAK trial key results for COGT's bezuclastinib combination?

PEAK reported a 50% reduction in risk of progression or death (HR 0.50), mPFS 16.5 months vs 9.2 months, and ORR 46% vs 26%.

How does the FDA's RTOR program affect Cogent's COGT NDA timeline?

RTOR allows pre‑submission review of components to accelerate FDA assessment; Cogent initiated RTOR immediately to expedite review ahead of an April 2026 complete submission.

Will Cogent present full PEAK trial data and when?

Yes; full PEAK results are planned for presentation at a major medical meeting in the first half of 2026.

What next clinical steps did Cogent outline for bezuclastinib (COGT)?

Cogent expects to start a Phase 2 trial in mid‑2026 testing the combination as first‑line therapy for GIST patients with exon 9 mutations.