Cogint

Cogent Biosciences, Inc. is a clinical-stage biopharmaceutical company, which engages in the development and commercialization of precision therapies for genetically defined diseases. It focuses on CGT9486, a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. The company was founded by Charles Wilson and Dario Campana in March 2014 and is headquartered in Waltham, MA.

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Cogent Biosciences, Inc. is a biotechnology company, which engages in the development of precision therapies for genetically defined diseases. It focuses on CGT9486, a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. The company was founded by Charles Wilson and Dario Campana in March 2014 and is headquartered in Waltham, MA.

On Sunday, Cogent Biosciences, Inc.  COGT revealed updated clinical results from the Open Label Extension (OLE) portion of the SUMMIT trial of bezuclastinib in patients with non-advanced systemic mastocytosis.

Why Is Cogent Biosciences Stock Trading Higher On Monday?

56% mean improvement in Total Symptom Score (TSS) at 24 weeks with 76% of patients achieving at least a 50% reduction in TSS

Cogent Biosciences Announces Updated Clinical Results from SUMMIT, Showcasing Powerful Symptomatic Improvement in NonAdvanced Systemic Mastocytosis Patients

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.

Cogent Biosciences Announces Positive Updated Data from Ongoing Phase 2 APEX Trial Evaluating Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)

Cogent (COGT) announces a positive FDA meeting and alignment on MS2D2, a novel patient-reported outcome measure for the SUMMIT study. The company's shares rise on the news.

Cogent (COGT) Up on SUMMIT Study Update Post Positive FDA Meeting

Patients treated with 100 mg bezuclastinib showed substantial reduction in their most severe symptoms and mast cell reactions

Cogent Biosciences Announces Additional Clinical Data from Part 1 of its Ongoing SUMMIT Trial Evaluating Bezuclastinib in Patients with NonAdvanced Systemic Mastocytosis (NonAdvSM)

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 product launches. At Cogent, he will be responsible for building and leading the commercial team including sales, marketing, access, and commercial operations. A key priority will be preparing the company for the potential commercial launch of bezuclastinib, for patients with systemic mastocytosis (SM) or Gastrointestinal Stromal Tumors (GIST).

Cogent Biosciences Appoints Cole Pinnow as Chief Commercial Officer

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 positive updated lead-in data from the company's ongoing Phase 3 PEAK trial evaluating the selective and potent KIT mutant inhibitor, bezuclastinib, in combination with sunitinib, in patients with Gastrointestinal Stromal Tumors (GIST). The data will be presented in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL on June 1. Cogent also announced today a new Phase 2 clinical trial of bezuclastinib plus sunitinib in later line GIST patients, sponsored by the Sarcoma Alliance for Research through Collaboration (SARC) and in collaboration with The Life Raft Group and Dana-Farber Cancer Institute.

Cogent Biosciences Announces Positive Updated Lead-In Data from Ongoing Phase 3 PEAK Trial Evaluating Bezuclastinib in Combination with Sunitinib in Patients with Gastrointestinal Stromal Tumors (GIST) at ASCO Annual Meeting

SUMMIT, PEAK and APEX registration-directed clinical trial enrollment remains on track; topline results expected from all three studies in 2025

Cogent Biosciences Reports First Quarter 2024 Financial Results

NEW YORK , April 18, 2024 /PRNewswire/ -- Purcell & Lefkowitz LLP announces that it is investigating Cogent Biosciences, Inc. (NASDAQ: COGT) on behalf of the company's shareholders.  The investigation seeks to determine whether Cogent Biosciences, Inc.'s directors breached their fiduciary duties in connection with recent corporate actions.

SHAREHOLDER ALERT: Purcell & Lefkowitz LLP Announces Shareholder Investigation of Cogent Biosciences, Inc. (NASDAQ: COGT)

Cogent Biosciences Presents Data Highlighting Potential Best-in-Class Potency and Selectivity of Novel, EGFR Sparing, CNS-Penetrant ErbB2 Inhibitor

•   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

Cogent Biosciences Reports Recent Business Highlights and Fourth Quarter and Full Year 2023 Financial Results

Registration-enabling SUMMIT Part 2 initiated and actively enrolling at 40 sites globally; RP2D selected at 100 mg once-daily optimized formulation based on:

Cogent Biosciences Announces Positive Part 1b Data from SUMMIT Trial Evaluating Bezuclastinib in Patients with Nonadvanced Systemic Mastocytosis

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 Biosciences Announces Oversubscribed $225 Million Private Placement

Company to Host Virtual Investor Webcast on Friday, February 23 at 8:00 a.m. ET Company to Host Virtual Investor Webcast on Friday, February 23 at 8:00 a.m. ET

Cogent Biosciences to Present SUMMIT Part 1b Data with Bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM) at the 2024 AAAAI Annual Meeting

WALTHAM, Mass. and BOULDER, Colo., Jan. 09, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc.  (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today highlighted the company's key 2024 milestones ahead of its presentation at J.P. Morgan's 42nd annual healthcare conference.

Cogent Biosciences Announces Planned 2024 Milestones for Bezuclastinib and Emerging Portfolio of Selective and Potent Targeted Therapeutics

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 42nd 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.

Cogent Biosciences Announces Presentation at the 42nd Annual J.P. Morgan Healthcare Conference

Cogent Biosciences Inc. shares COGT, -1.48% fell more than 30% premarket on Monday after the company over the weekend released clinical trial data on its lead drug candidate that failed to outshine potential competitors, in analysts' view. In a trial of bezuclastinib in patients with nonadvanced systemic mastocytosis, a rare blood disorder in which too many mast cells build up in the body, everyone treated with the therapy achieved at least 50% improvement in all relevant biomarker measures, Cogent said Friday at the American Society of Hematology annual meeting in San Diego.

Cogent Biosciences stock drops as analysts see tough competition for mastocytosis treatment

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

Cogent Biosciences Announces Positive Data from Ongoing Phase 2 APEX Trial Evaluating Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)

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

Cogent Biosciences Announces Positive Initial Data from Phase 2 SUMMIT Trial Evaluating Bezuclastinib in Patients with Nonadvanced Systemic Mastocytosis (NonAdvSM)

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

Cogent Biosciences Presents New Preclinical Data Highlighting Potential Best-in-Class Potency and Selectivity of ErbB2 and PI3Kα inhibitor programs at the San Antonio Breast Cancer Symposium

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.

Cogent Biosciences Announces Poster Presentations at Upcoming San Antonio Breast Cancer Symposium

SUMMIT and APEX clinical presentations planned for 2023 ASH Annual Meeting; SUMMIT NonAdvSMdata selected for oral presentation

Cogent Biosciences Reports Recent Business Highlights and Third Quarter 2023 Financial Results

– Novel selective and reversible FGFR2 inhibitor exhibits strong potency across key primary and resistance driver mutations with potential advantages over covalent approaches –

Cogent Biosciences Presents Preclinical Data Highlighting Precision Oncology Pipeline at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

Cogent Biosciences, Inc. is developing the lead asset bezuclastinib, a KIT inhibitor, in various indications. The company has demonstrated positive clinical data for bezuclastinib in advanced systemic mastocytosis. Cogent Bio's financials show a market cap of $1.04bn and a cash balance of $350mn, with a cash runway into 2025.

Cogent Biosciences Is Beginning To Differentiate Its KIT Inhibitor

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

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