PEAK NDA initiated for bezuclastinib in patients with 2L GIST under Real-Time Oncology Review (RTOR) and Breakthrough Therapy Designation (BTD); completion of NDA on track for April 2026
Six abstracts from SUMMIT trial of bezuclastinib in patients with NonAdvSM accepted for presentation at 2026 AAAAI annual meeting
Strong financial position with $901 million sufficient to fund operations into 2028
WALTHAM, Mass. and BOULDER, Colo., Feb. 17, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (NASDAQ:COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and reported financial results for the fourth quarter and full year of 2025.
"Following three positive pivotal trials in 2025, we have entered 2026 with tremendous momentum and multiple value-creating regulatory catalysts underway," said Andrew Robbins, Cogent's President and Chief Executive Officer. "We have submitted our SUMMIT NDA for bezuclastinib in patients with NonAdvSM, initiated our PEAK NDA under the FDA's RTOR program for bezuclastinib in patients with second-line GIST, and remain on track to submit our APEX NDA for bezuclastinib in patients with AdvSM in the first half of this year. These recent and upcoming milestones underscore the breadth of bezuclastinib's best-in-class potential across KIT-mutant driven diseases. With a very strong balance sheet entering 2026, we will soon finish building our commercial organization and will be ready to launch bezuclastinib in the second half of 2026."
Recent Company Highlights
In February 2026, announced that six abstracts from the SUMMIT trial of bezuclastinib in patients with NonAdvanced Systemic Mastocytosis (NonAdvSM) have been accepted for presentation at the 2026 AAAAI annual meeting.
In January 2026, announced that the U. S. Food and Drug Administration (FDA) agreed to accept the PEAK NDA for bezuclastinib in patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib under the Real-Time Oncology Review (RTOR) program. Shortly thereafter Cogent initiated the NDA submission to the FDA under this program. Based on the results from the PEAK trial, in January 2026 bezuclastinib was also granted Breakthrough Therapy Designation for this patient population.
In December 2025, presented full data from the SUMMIT trial evaluating bezuclastinib in patients with NonAdvSM, at the American Society of Hematology (ASH) annual meeting, and submitted an NDA for bezuclastinib in NonAdvSM, supported by the SUMMIT dataset. Key findings from SUMMIT included:
Clear clinical benefit across all symptom domains, including significant improvements across 11 individual symptoms and the most severe symptom at baseline
Reduction in objective measures of disease, including serum tryptase, correlating with improvements in symptom severity, representing the first demonstration of this relationship in NonAdvSM patients
Forty-eight-week data showing continued deepening of symptomatic improvement over time
In December 2025, announced topline results from the APEX trial evaluating bezuclastinib in patients with Advanced Systemic Mastocytosis (AdvSM), APEX is a registration-directed, global, open-label trial evaluating bezuclastinib in patients with AdvSM. Key findings included:
Rapid and deep clinical benefit, with an objective response rate (CR+CRh+PR+CI) of 57% per mIWG criteria and 80% per PPR criteria
A powerful effect on mast cell burden, with 89% of patients achieving a ≥50% reduction in bone marrow mast cells or clearance of aggregates
In December 2025, announced initial preclinical results from the company's novel, potent, selective JAK2 V617F inhibitor CGT1145 at the ASH annual meeting. These results showcased greater than 100-fold selectivity for JAK2 V617F mutations over JAK2 WT inhibition, positioning CGT1145 with a potential best-in-class profile.
In November 2025, successfully completed concurrent public offerings of common stock and convertible senior notes for net proceeds of approximately $546.8 million.
In November 2025, announced topline results from the Phase 3 PEAK trial of bezuclastinib in combination with sunitinib for patients with GIST who have received prior treatment with imatinib, becoming the first positive Phase 3 trial in second-line GIST patients in over 20 years. Highlights include:
16.5 months median progression free survival (mPFS) for bezuclastinib plus sunitinib compared to 9.2 months mPFS for sunitinib monotherapy (HR=0.50, CI: 0.39-0.65; p<0.0001)
46% Objective Response Rate (ORR) reported for bezuclastinib combination compared to 26% ORR for sunitinib monotherapy (p<0.0001)
The safety profile of the bezuclastinib combination was well tolerated with no unique risks observed with the combination when compared to the known safety profile of sunitinib
In October 2025, shared progress on Cogent's internally developed KRAS(ON/OFF) inhibitor CGT1263 in a poster at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Updated results demonstrated clear selectivity over HRAS and NRAS, with picomolar (pM) activity across a broad panel of KRAS mutant cell lines. In addition, the poster also characterized CGT1815 (the prodrug of CGT1263), which is designed to optimize human pharmacokinetic performance, supported by pharmacokinetics data from both CGT1815 and CGT1263 across multiple species. Finally, the poster highlighted outcompete data in KRASG12D and KRASG12V tumor growth inhibition studies when compared to other KRAS exemplars including RMC-6236.
Projected Near-Term Milestones
Bezuclastinib
Acceptance of the NDA for bezuclastinib in NonAdvSM in February 2026
Complete submission of PEAK NDA in April 2026 for bezuclastinib in patients with GIST who have received prior treatment with imatinib
Submit APEX NDA in 1H 2026 for bezuclastinib in patients with AdvSM
Present detailed clinical data from the PEAK and APEX pivotal trials at major medical meetings during 1H 2026
Present updated SUMMIT data across six poster presentations at the AAAAI Annual meeting in February 2026
Pending FDA approval, launch bezuclastinib in the second half of 2026
Pipeline
Submit Investigational New Drug (IND) applications for CGT1815, Cogent's novel, selective pan-KRAS(ON) inhibitor and CGT1145, Cogent's novel, selective JAK2 V617F inhibitor
Share clinical data on CGT4859, Cogent's selective and potent FGFR 2/3 inhibitor, from its Phase 1/2 study in patients with alterations in FGFR2 or FGFR3
Complete dose escalation for both CGT4255, Cogent's CNS-penetrant, selective mutant ErbB2 inhibitor, and CGT6297, Cogent's novel, selective PI3Kα inhibitor
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. A growing number of sites now offer access to the bezuclastinib EAPs. For more information please visit: https://www.cogentbio.com/bezuclastinib-program-development/#our-expanded-access-policy
Upcoming Investor Conference
Leerink Healthcare Conference on Wednesday, March 11 at 10:40 a.m. ET.
A live webcast can be accessed on the Investors & Media page of Cogent's website at investors.cogentbio.com/events. A replay will be available approximately two hours after completion of the event and will be archived for up to 30 days.
Fourth Quarter and Full Year 2025 Financial Results
Cash and Cash Equivalents: As of December 31, 2025, Cogent had cash, cash equivalents and marketable securities of $900.8 million. Fourth quarter cash usage was driven largely by non-recurring items, including the repayment of $54.8 million of long-term debt and approximately $38.5 million of one-time, performance-based equity compensation.
R&D Expenses: Research and development expenses were $75.6 million for the fourth quarter of 2025 and $269.8 million for the year ended December 31, 2025, as compared to $62.0 million for the fourth quarter of 2024 and $232.7 million for the year ended December 31, 2024. The change was driven by the continued development of bezuclastinib across three pivotal trials, including costs associated with the completed and planned NDA filings, as well as the continued progression of our early stage, preclinical and discovery programs. R&D expenses include non-cash stock compensation expense of $7.5 million for the fourth quarter of 2025 and $23.1 million for the year ended December 31, 2025, as compared to $5.0 million for the fourth quarter of 2024 and $19.0 million for the year ended December 31, 2024.
G&A Expenses: General and administrative expenses were $23.9 million for the fourth quarter of 2025 and $63.6 million for the year ended December 31, 2025, as compared to $11.7 million for the fourth quarter of 2024 and $43.3 million for the year ended December 31, 2024. The increase was primarily due to the growth of the organization and activities related to the anticipated commercial launch of bezuclastinib. G&A expenses include non-cash stock compensation expense of $8.3 million for the fourth quarter of 2025 and $23.0 million for the year ended December 31, 2025, as compared to $5.0 million for the fourth quarter of 2024 and $20.8 million for the year ended December 31, 2024.
Net Loss: Net loss was $102.5 million for the fourth quarter of 2025 and $328.9 million for the year ended December 31, 2025, as compared to a net loss of ...
