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Cogent Biosciences Announces Submission of New Drug Application (NDA) for Bezuclastinib in Advanced Systemic Mastocytosis (AdvSM)
Submission based on results of APEX pivotal trial which demonstrated bezuclastinib objective response rate (CR+CRh+PR+CI) of 65% per mIWG criteria and 81% ORR per PPR criteria with a well-tolerated safety profile for AdvSM patients APEX NDA is third submission for bezuclastinib in six months; PEAK
June 30, 2026
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Cogent Biosciences Announces Preclinical Data from Novel JAK2 V617F Inhibitor at the 2026 European Hematology Association (EHA) Congress
-  JAK2 V671F poster presentation showcases potential best-in-class properties, including improved selectivity compared with currently approved JAK inhibitors - - Selective JAK V617F inhibitor, CGT1145, on track for IND in 2026 - WALTHAM, Mass. and BOULDER, Colo., June 12, 2026 (GLOBE NEWSWIRE) --
June 12, 2026
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Cogent Biosciences Announces Detailed Data from APEX Pivotal Trial of Bezuclastinib in Patients with Advanced Systemic Mastocytosis at the 2026 European Hematology Association (EHA) Congress
-- Bezuclastinib demonstrated rapid and deep clinical benefit in AdvSM patients resulting in an updated objective response rate (CR+CRh+PR+CI) of 65% per mIWG criteria and 81% ORR per PPR criteria – -- Bezuclastinib demonstrated a powerful effect on mast cell burden with 91% of patients achieving
June 12, 2026
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Cogent Biosciences Announces Detailed Clinical Data from PEAK Phase 3 Trial with Bezuclastinib in Combination with Sunitinib in Gastrointestinal Stromal Tumors (GIST) at 2026 American Society of Clinical Oncology (ASCO) Annual Meeting
Bezuclastinib combination is first treatment ever to demonstrate statistically significant advantage against 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 Bezuclastinib
May 30, 2026
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Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GIST
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
May 28, 2026
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Cogent Biosciences Announces Participation in the 2026 Jefferies Global Healthcare Conference
WALTHAM, Mass. and BOULDER, Colo., May 27, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc.  (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced its participation in the Jefferies Global Healthcare Conference in New
May 27, 2026
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Cogent Biosciences Announces Multiple Presentations at the European Hematology Association (EHA) 2026 Congress
Pivotal data from APEX trial in Advanced Systemic Mastocytosis accepted for oral presentation; Cogent’s third oral presentation of pivotal data with bezuclastinib at major medical meetings   Preclinical data from selective, potent JAK2 V617F program accepted for poster presentation WALTHAM, Mass.
May 12, 2026
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Cogent Biosciences Reports Recent Business Highlights and First Quarter 2026 Financial Results
- Planning for dual launches of bezuclastinib in Systemic Mastocytosis and Gastrointestinal Stromal Tumors (GIST) - Pivotal data from Phase 3 PEAK trial in GIST patients selected for oral presentation at 2026 ASCO annual meeting  - Ended 1Q 2026 with $866.4 million in cash, sufficient to fund
May 5, 2026
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Cogent Biosciences Announces Oral Presentation of Positive Phase 3 PEAK Trial in Gastrointestinal Stromal Tumors (GIST) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting
WALTHAM, Mass. and BOULDER, Colo., April 21, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc.  (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that the results from the Phase 3 PEAK trial have been selected for
April 21, 2026
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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
April 17, 2026
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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.
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