On January 12, 2026 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the company’s key 2026 milestones ahead of its presentation at J.P. Morgan’s 44th annual healthcare conference.
"2025 was marked by exceptional progress at Cogent Biosciences," said Andrew Robbins, President and Chief Executive Officer. "We reported positive results from all three pivotal trials of bezuclastinib in patients with GIST and Systemic Mastocytosis, submitted our first NDA for bezuclastinib in patients with NonAdvSM based on the strength of the SUMMIT data, and put ourselves in a very strong financial position entering the new year. During 2026, we will transform Cogent into a fully integrated commercial stage company with plans to launch bezuclastinib in the second half of the year. In addition, we are investing for the future and plan to submit INDs in 2026 for both our pan-KRAS inhibitor and recently announced JAK2 V617F inhibitor. Our plans are supported by a highly experienced team with proven launch experience backed by a strong balance sheet. We are poised for success and extremely excited about the meaningful impact we can have for patients."
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In 2026, Cogent plans to achieve the following milestones:
Bezuclastinib
Acceptance of the New Drug Application (NDA) for bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM) by the end of February 2026
Submit an NDA in April 2026 for bezuclastinib in patients with advanced Gastrointestinal Stromal Tumors (GIST) previously treated with imatinib based on the strength of the PEAK pivotal trial
Submit an NDA in 1H 2026 for bezuclastinib in patients with Advanced Systemic Mastocytosis (AdvSM) based on the strength of the APEX pivotal trial
Present detailed, updated clinical data from each of the three pivotal trials (SUMMIT, PEAK, APEX) at major medical meetings during 1H 2026
Commercialize bezuclastinib following potential FDA approval in 2H 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
Present 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 selective PI3Kα inhibitor
Bezuclastinib Expanded Access Programs
Working with the FDA, Cogent has established active Expanded Access Programs 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 investigational sites now offer access to the bezuclastinib EAPs. For more information please visit: View Source
New Leadership Appointment
Cogent also announced today that Abb Hayden has joined Cogent as Senior Vice President, Sales. Mr. Hayden joins Cogent with over 25 years of industry experience. Previously he served as Vice President of Commercial at Syndax Pharmaceuticals. While at Syndax, he played an integral part in building the commercial infrastructure leading the Field Sales, Marketing, and Clinical Education team to launch Revuforj and Niktimvo. Prior to Syndax, he held roles of increasing responsibility at Adaptive Biotechnologies, Onyx Pharmaceuticals, and Eli Lilly. Mr. Hayden is a graduate of the University of Central Arkansas.
J.P. Morgan Presentation Details
Cogent will participate in a presentation and Q&A session at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, beginning at 8:15 a.m. PT (11:15 a.m. ET). A live webcast will be accessible in the "Investors & Media" section of the company’s website, www.cogentbio.com, and will be archived for 30 days following the event.
Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Cogent also announced today that, on January 9, 2026, the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, approved the grant of "inducement" equity awards to five new employees under the company’s 2020 Inducement Plan with a grant date of January 9, 2026. The awards were approved in accordance with Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq Stock Market. The employees received, in the aggregate, (i) nonqualified options to purchase 66,700 shares of Cogent common stock and (ii) 9,700 restricted stock units (RSUs). Each option has a 10-year term, an exercise price equal to the closing price of Cogent’s common stock on the grant date, and a 4-year vesting schedule with 25% vesting on the 1-year anniversary of the grant date and the remainder vesting in equal monthly installments over the subsequent 36 months, provided such employee remains employed through each such vesting date. The RSUs vest annually in equal installments over 4 years from the grant date, provided such employee remains employed through each such vesting date.
(Press release, Cogent Biosciences, JAN 12, 2026, View Source [SID1234661943])