Press Releases

Search

April 17, 2026
Cogent Biosciences Announces Poster Presentations at the American Association for Cancer Research (AACR) Annual Meeting 2026
– Updated presentation on Cogent’s potent pan-KRAS(ON) inhibitor, CGT1263, showcasing its selectivity profile which could lead to reduction in skin toxicity associated with multi-RAS inhibitors – Updated presentation on Cogent’s brain penetrant ErbB2 inhibitor, CGT4255, with evidence of synergistic
Read More
April 1, 2026
Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in Gastrointestinal Stromal Tumors (GIST)
Bezuclastinib NDA submitted under the FDA’s RTOR program based on positive results from Phase 3 PEAK trial; bezuclastinib previously granted Breakthrough Therapy Designation in GIST Bezuclastinib combination demonstrated 16.5 month mPFS and 46% ORR in imatinib-resistant GIST patients, dramatically
Read More
March 16, 2026
Cogent Biosciences Announces FDA Acceptance of New Drug Application for Bezuclastinib in Patients with NonAdvanced Systemic Mastocytosis (NonAdvSM)
NDA based on positive clinical results from the SUMMIT pivotal trial in which bezuclastinib demonstrated clear clinical benefit across all symptom domains WALTHAM, Mass. and BOULDER, Colo., March 16, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc.  (Nasdaq: COGT), a biotechnology company focused
Read More
February 28, 2026
Cogent Biosciences Highlights Additional Data with Six Bezuclastinib Posters from SUMMIT Trial at 2026 AAAAI Annual Meeting
Bezuclastinib mean TSS reduction deepens to –32.0 points at 48 weeks of treatment with further improvement shown across all measured symptoms 99% of patients achieve >50% reduction in serum tryptase at 48 weeks, with 83% rate of normalization Strong evidence of bezuclastinib’s potential as first
Read More
February 17, 2026
Cogent Biosciences Reports Recent Business Highlights and Fourth Quarter and Full Year 2025 Financial Results
SUMMIT NDA for bezuclastinib in patients with NonAdvSM submitted in December 2025; APEX NDA submission for bezuclastinib in patients with AdvSM on track for 1H 2026 PEAK NDA initiated for bezuclastinib in patients with 2L GIST under Real-Time Oncology Review (RTOR) and Breakthrough Therapy
Read More
February 10, 2026
Cogent Biosciences Announces Multiple SUMMIT Posters at the 2026 AAAAI Annual Meeting
WALTHAM, Mass. and BOULDER, Colo., Feb. 10, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc.  (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced multiple upcoming posters highlighting bezuclastinib results from the
Read More
January 26, 2026
Cogent Biosciences Announces Breakthrough Therapy Designation for Bezuclastinib in Combination with Sunitinib for Patients with Gastrointestinal Stromal Tumors (GIST)
-   Cogent will submit the PEAK New Drug Application (NDA) under previously announced RTOR designation; on track to complete NDA submission in April 2026 WALTHAM, Mass. and BOULDER, Colo., Jan. 26, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc.  (Nasdaq: COGT), a biotechnology company focused on
Read More
January 20, 2026
Cogent Biosciences to Initiate New Drug Application (NDA) Submission for Bezuclastinib Under Real-Time Oncology Review (RTOR) 
-  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
Read More
January 12, 2026
Cogent Biosciences Announces Anticipated 2026 Commercial and Clinical Milestones for Bezuclastinib and Precision Therapies Portfolio
New Drug Application (NDA) for NonAdvSM submitted in December 2025, NDA submission for AdvSM on track for 1H 2026 NDA submission for GIST on track for April 2026; bezuclastinib has the potential to be the first new therapy for second-line GIST in over 20 years Clinical data presentations from all
Read More
January 6, 2026
Cogent Biosciences Announces Presentation at the 44th Annual J.P. Morgan Healthcare Conference
WALTHAM, Mass. and BOULDER, Colo., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc.  (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that Andrew Robbins, President and Chief Executive Officer, will present
Read More


The press releases contained in this archive section are provided for historical purposes only. The information contained in each press release is accurate only as of the date each press release was originally issued. Unum disavows any obligation to update the information contained in such press releases after the date of their issuance.
Scroll to Top