56% mean improvement in Total Symptom Score (TSS) at 24 weeks with 76% of patients achieving at least a 50% reduction in TSS 89% of patients had >50% decrease in serum tryptase by four weeks of treatment and 95% of patients with elevated baseline tryptase achieved serum tryptase levels <20 ng/ml by week 24 SUMMIT Part 2 enrollment completed early; surpassing original enrollment target with 179 patients enrolled, top-line... Read More

52% ORR per mIWG criteria, including 83% ORR for patients receiving 100 mg BID 88% ORR per PPR criteria, including 100% ORR for patients receiving 100 mg BID Median time to response 2.2 months with median duration of response and median PFS not yet reached Top-line data from APEX Part 2 on-track for mid-2025 Cogent to host investor webcast on Monday, December 9 at 8:00 a.m. ET WALTHAM, Mass. and BOULDER, Colo., Dec. 08, 2024... Read More

Top-line results from registration-directed SUMMIT, PEAK and APEX trials expected in 2025 Phase 1 trial initiated for CGT-4859, a reversible, potent, selective, FGFR2 inhibitor SUMMIT and APEX clinical presentations at upcoming ASH annual meeting Strong cash position of $346 million sufficient to fund operations into late 2026 WALTHAM, Mass. and BOULDER, Colo., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc.... Read More

WALTHAM, Mass. and BOULDER, Colo., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced two presentations featuring bezuclastinib at the 66 th Annual Meeting of the American Society of Hematology (ASH) being held December 7-10, 2024 in San Diego, California. The first presentation will... Read More

Preclinical data highlight company’s fourth discovery stage program, a novel potent and selective KRAS(ON) inhibitor Updated preclinical data from CGT6297, Cogent’s H1047R mutant-selective PI3Kα inhibitor demonstrates robust inhibition of downstream signaling and efficacy WALTHAM, Mass. and BOULDER, Colo., Oct. 23, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing... Read More

413 patients enrolled in PEAK Phase 3 GIST trial, exceeding enrollment target; top-line results expected by end of 2025 PEAK interim futility analysis completed with no changes to study Registration-directed SUMMIT trial in NonAdvanced Systemic Mastocytosis (NonAdvSM) now on track to complete enrollment in Q1 2025; top-line results expected 2H 2025 WALTHAM, Mass. and BOULDER, Colo., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Cogent... Read More

SUMMIT, PEAK and APEX registration-directed clinical trial enrollment remains on track; topline results expected from all three studies in 2025 Ended 2Q 2024 with $390 million, sufficient to fund operations into 2027 WALTHAM, Mass. and BOULDER, Colo., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases,... Read More

WALTHAM, Mass. and BOULDER, Colo., June 27, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced it has reached alignment with the U.S. Food and Drug Administration (FDA) on the Company’s novel patient reported outcome measure, Mastocytosis Symptom Severity Daily Diary (MS2D2), for use in Part 2 of... Read More

Patients treated with 100 mg bezuclastinib showed substantial reduction in their most severe symptoms and mast cell reactions Reductions were shown in all individual MS2D2 symptoms across domains and objective reduction in skin lesions corresponding with symptomatic improvement WALTHAM, Mass. and BOULDER, Colo., June 14, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on... Read More

WALTHAM, Mass. and BOULDER, Colo., May 23, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced the appointment of Cole Pinnow as Chief Commercial Officer. Mr. Pinnow is a leader in the biopharmaceutical industry with an impressive track record in commercial strategy, including several successful... Read More

Bezuclastinib + sunitinib combination therapy reached median progression free survival (mPFS) of 19.4-months and 33% ORR in subset of advanced GIST patients with one prior treatment Encouraging long-term safety and tolerability with combination bezuclastinib and sunitinib therapy in Part 1 PEAK Phase 3 guidance accelerated with enrollment completion now expected in 3Q 2024 Company announces new advanced GIST clinical trial... Read More

SUMMIT, PEAK and APEX registration-directed clinical trial enrollment remains on track; topline results expected from all three studies in 2025 Ended 1Q 2024 with $435.7 million in cash, sufficient to fund operations into 2027 WALTHAM, Mass. and BOULDER, Colo., May 07, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined... Read More

WALTHAM, Mass. and BOULDER, Colo., April 09, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced new preclinical data from the Company’s potent, selective, CNS-penetrant ErbB2 inhibitor program. The data are being presented in a poster session at the American Association for Cancer Research (AACR)... Read More

UMMIT Part 2 registration-directed study of bezuclastinib in NonAdvSM patients initiated and actively enrolling at 40 sites globally; once-daily 100 mg selected as RP2D; topline results expected by YE 2025 PEAK Phase 3 study of bezuclastinib + sunitinib in 2 nd -line GIST patients on track to complete enrollment by end of 2024; topline results expected by YE 2025 APEX Part 2 registration-directed study of bezuclastinib in... Read More

Registration-enabling SUMMIT Part 2 initiated and actively enrolling at 40 sites globally; RP2D selected at 100 mg once-daily optimized formulation based on: 51% week 12 mean change in Total Symptom Score (TSS), including 70% of patients achieving ≥50% reduction in TSS at week 12 49% week 12 mean improvement in quality-of-life (McQoL) Safety and tolerability profile generally similar to placebo with no grade 3/4 events; no... Read More

Pro-forma cash, cash equivalents and marketable securities expected to fund the Company into 2027 and through clinical readouts from ongoing SUMMIT, PEAK and APEX registration-directed trials Cogent to host investor webcast at 8:00 a.m. ET on February 23 to review the SUMMIT Part 1b data with bezuclastinib at AAAAI annual meeting WALTHAM, Mass. and BOULDER, Colo., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc.... Read More

WALTHAM, Mass. and BOULDER, Colo., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced its upcoming posters for bezuclastinib at the 2024 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI) being held in Washington, D.C. from February 23-26, 2024. The company will host... Read More

Plan to initiate global, registration-directed SUMMIT Part 2 study of bezuclastinib in NonAdvSM patients during 1H 2024; present results from complete SUMMIT Part 1 at 2024 AAAAI annual conference in Q1 2024 On track to complete enrollment in global, pivotal Phase 3 PEAK study of bezuclastinib + sunitinib in 2 nd -line GIST patients by end of 2024 On track to complete enrollment in registration-directed Phase 2 APEX study of... Read More

WALTHAM, Mass. and BOULDER, Colo., Jan. 02, 2024 (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 at the 42 nd Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 9, 2024 at 4:30 p.m. PT/7:30 p.m. ET.... Read More

56% ORR in TKI-naïve patients, including 86% ORR by PPR criteria and 100% ORR in APEX patients treated at 100 mg BID with exposures consistent with go-forward dose Nearly all patients achieved at least 50% improvement in key biomarkers of disease burden: serum tryptase reduction (94%), KIT D816V VAF reduction (93%), and bone marrow mast cell burden (97%) Encouraging safety and tolerability profile with no related cognitive... Read More

Rapid and ongoing improvement in patient symptoms, with 57% median best improvement on MC-QoL and 78% of patients reporting ≥1 point improvement on PGIS by week 20 100% of bezuclastinib treated patients achieved at least 50% improvement across all relevant biomarker measures, including serum tryptase, KIT D816V VAF, and mast cell burden; Placebo patients, after cross-over to bezuclastinib, also demonstrated rapid symptomatic... Read More

Novel EGFR-sparing, brain-penetrant ErbB2 inhibitor demonstrates superior efficacy profile reaching 80% brain penetrance with potent coverage of key mutations inadequately addressed by currently approved therapies Novel, H1047R mutant-selective PI3Kα inhibitor, disclosed as third Cogent discovery stage program, demonstrates high clinical target engagement without metabolic dysfunction commonly associated with molecules in... Read More

Event to review initial clinical data from SUMMIT Part 1a in patients with Nonadvanced Systemic Mastocytosis (NonAdvSM) Additional clinical data update from APEX Part 1 in patients with Advanced Systemic Mastocytosis (AdvSM) also to be reviewed WALTHAM, Mass. and BOULDER, Colo., Dec. 04, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for... Read More

WALTHAM, Mass. and BOULDER, Colo., Nov. 29, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced two poster presentations at the upcoming 2023 San Antonio Breast Cancer Symposium (SABCS), taking place December 5-9, 2023 at the Henry B. González Convention Center in San Antonio, Texas. Poster... Read More

SUMMIT and APEX clinical presentations planned for 2023 ASH Annual Meeting; SUMMIT NonAdvSM data selected for oral presentation SUMMIT Part I completed upsized enrollment during Q3; SUMMIT Part 2 expected to begin in 1H 2024 at over 50 sites globally 33% ORR and >14 months median duration of treatment for 2 nd -line GIST patients from updated PEAK lead-in data presented at 2023 CTOS Annual Meeting Ended Q3 2023 with $312.8... Read More

Novel selective and reversible FGFR2 inhibitor exhibits strong potency across key primary and resistance driver mutations with potential advantages over covalent approaches IND and initiation of clinical trial planned in 2H 2024 WALTHAM, Mass. and BOULDER, Colo., Oct. 14, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined... Read More

Initial clinical results from Phase 2 SUMMIT trial in NonAdvSM along with updated data from Phase 2 APEX trial in AdvSM on track for 2H 2023 Enrollment for Phase 3 PEAK trial in GIST continues on track Selective FGFR2 inhibitor nominated as first Cogent-discovered clinical candidate; additional preclinical data planned for presentation in 2H 2023 Ended 2Q 2023 with $350.9 million, sufficient to fund operations into 2026... Read More

WALTHAM, Mass. and BOULDER, Colo., June 09, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced the closing of its previously announced upsized underwritten public offering of 12,500,000 shares of its common stock. The public offering price of each share of common stock was $12.00. The aggregate... Read More

WALTHAM, Mass. and BOULDER, Colo., June 07, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced its participation in a fireside chat at the Jefferies Healthcare Conference in New York on Thursday, June 8, 2023 at 9:30 a.m. ET. A live webcast will be available on the Investors & Media page of... Read More

WALTHAM, Mass. and BOULDER, Colo., June 06, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced the pricing of its previously announced underwritten public offering of 12,500,000 shares of its common stock, offered at a public offering price of $12.00 per share. The aggregate gross proceeds to... Read More

CAMBRIDGE, Mass. and BOULDER, Colo., June 06, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that it has commenced an underwritten public offering of $125 million of shares of its common stock. In addition, Cogent has granted the underwriters a 30-day option to purchase up to an additional... Read More

Data presented at ASCO annual meeting demonstrate 55% Disease Control Rate (DCR) in heavily pre-treated GIST patients, including 100% DCR and 17% overall response rate (ORR) in efficacy evaluable 2 nd -line GIST patients; data immature to estimate progression free survival (PFS) Combination of bezuclastinib and sunitinib is well-tolerated and consistent with published sunitinib monotherapy safety profile Cogent to host... Read More

WALTHAM, Mass. and BOULDER, Colo., May 23, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced the details of its investor webcast being held Monday, June 5, 2023 at 8:00 a.m. ET (7:00 a.m. CT) to discuss lead-in data from its ongoing Phase 3 PEAK trial evaluating bezuclastinib in combination with... Read More

Lead-in data from Phase 3 PEAK trial to be presented at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting Announced initiation of APEX Part 2 expansion trial; on-track to present initial SUMMIT clinical data in 2H 2023 Ended 1Q 2023 with $220.3 million in cash, sufficient to fund operations into 2025 WALTHAM, Mass. and BOULDER, Colo., May 09, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq:... Read More

Preclinical data describes a novel EGFR-sparing, brain-penetrant ErbB2 inhibitor active against key oncogenic ErbB2 mutations In vivo characterization shows a novel, selective, reversible FGFR2 inhibitor has potency against molecular brake mutations and potential advantages over covalent approaches APEX Part 2 underway in AdvSM patients at once-daily 150 mg optimized dose of bezuclastinib WALTHAM, Mass. and BOULDER, Colo.,... Read More

WALTHAM, Mass. and BOULDER, Colo., April 12, 2023 (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 following upcoming virtual investor conferences: 22 nd Annual Needham Healthcare Conference Wednesday, April 19, 2023 at 2:15 p.m. ET Stifel 2023 Targeted Oncology Days... Read More

Initiation of APEX Part 2 planned for mid-2023 Updated clinical data from Phase 3 PEAK lead-in in GIST patients expected 1H23 Initial clinical data from Phase 2 SUMMIT trial in NonAdvSM on-track for 2H23 Ended 2022 with $259.3 million in cash; sufficient to fund operations into 2025 WALTHAM, Mass. and BOULDER, Colo., March 14, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused... Read More

WALTHAM, Mass. and BOULDER, Colo., Feb. 01, 2023 (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 participate in the following upcoming investor conferences in February: Guggenheim Healthcare Talks Idea Forum Oncology Day Date/Time:... Read More

Demonstrate significant progress toward leadership in Systemic Mastocytosis (SM), including mid-year Part 1 results from Phase 2 APEX trial in AdvSM patients and initial clinical data in 2H23 from Phase 2 SUMMIT trial in NonAdvSM patients Rapidly progress bezuclastinib in 2 nd -line Gastrointestinal Stromal Tumors (GIST), with planned clinical update from lead-in portion of Phase 3 PEAK trial in 1H23, and expansion to >100... Read More

WALTHAM, Mass. and BOULDER, Colo., Jan. 05, 2023 (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 at the 41 st Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, January 12, 2023 at 7:30 a.m. PT/10:30 a.m.... Read More

89% ORR in TKI-therapy naïve patients; 73% ORR in all evaluable patients with 27-week median follow-up Rapid and deep responses seen including first confirmed CR at 20 weeks; 77% of patients with at least 2 cycles of treatment had complete clearance of bone marrow mast cell aggregates Favorable safety and tolerability profile with no related cognitive effects or reported intracranial bleeding events Cogent to host investor... Read More