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Cogent Biosciences (NasdaqGS:COGT) FY Earnings Call Presentation
2026-01-13 16:15
J.P. Morgan Annual Meeting January 13, 2026 Forward-Looking Statements and Risk Factors This presentation and the accompanying oral commentary contain forward-looking statements that involve risks, uncertainties and assumptions. If the risks or uncertainties ever materialize or the assumptions prove incorrect, our results may differ materially from those expressed or implied by such forward looking statements. All statements other than statements of historical fact could be deemed forward-looking, including ...
Cogent Biosciences Announces Anticipated 2026 Commercial and Clinical Milestones for Bezuclastinib and Precision Therapies Portfolio - Cogent Biosciences (NASDAQ:COGT)
Benzinga· 2026-01-12 13:00
Core Insights - Cogent Biosciences, Inc. is poised for significant advancements in 2026, focusing on the commercialization of bezuclastinib and expanding its pipeline of targeted therapies [2][6][11] Milestones for 2026 - The company plans to launch bezuclastinib in the second half of 2026, following the submission of multiple New Drug Applications (NDAs) for various indications [2][6][7] - An NDA for bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM) was submitted in December 2025, with acceptance expected by the end of February 2026 [6][7] - An NDA for bezuclastinib in Advanced Gastrointestinal Stromal Tumors (GIST) is on track for submission in April 2026, potentially marking the first new therapy for second-line GIST in over 20 years [6][7] - Clinical data from pivotal trials (SUMMIT, PEAK, APEX) will be presented at major medical meetings in the first half of 2026 [6][7] Financial Position - Cogent enters 2026 with approximately $900 million in cash, which is expected to fund commercial launches and operations well into 2028 [6][7] Leadership and Team - Abb Hayden has been appointed as Senior Vice President of Sales, bringing over 25 years of industry experience to the company [8] Expanded Access Programs - The company has established Expanded Access Programs for U.S. patients with GIST or Systemic Mastocytosis, allowing access to bezuclastinib for eligible patients [8]
Cogent Biosciences Announces KRAS Poster Presentation at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
Globenewswire· 2025-10-24 16:30
Core Insights - Cogent Biosciences, Inc. presented updated preclinical data on its pan KRAS(ON) inhibitor at the 2025 AACR-NCI-EORTC International Conference, indicating a potential best-in-class profile for its lead molecule [1][2] Group 1: Product Development - The pan KRAS(ON) program aims to file an Investigational New Drug (IND) application with the FDA in 2026 [2] - The presented data highlights CGT1263, a potent KRAS inhibitor, demonstrating selectivity for mutant KRAS over HRAS and NRAS, with picomolar activity across various KRAS mutant cell lines [3] - CGT1815, the prodrug of CGT1263, is designed to optimize pharmacokinetic performance, showing superior efficacy in tumor growth inhibition studies compared to RMC-6236 [3] Group 2: Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with its most advanced clinical program being bezuclastinib, a selective tyrosine kinase inhibitor targeting the KIT D816V mutation [4] - The company is also conducting a Phase 1 study of a novel FGFR2/3 inhibitor and developing therapies targeting mutations in ErbB2, PI3Kα, and KRAS [4]
Cogent Biosciences Announces KRAS Poster Presentation at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
Globenewswire· 2025-10-24 16:30
Core Insights - Cogent Biosciences, Inc. presented updated preclinical data on its pan KRAS(ON) inhibitor at the 2025 AACR-NCI-EORTC International Conference, indicating a potential best-in-class profile for its lead molecule [1][2] Group 1: Product Development - The pan KRAS(ON) program aims to file an Investigational New Drug (IND) application with the FDA in 2026 [2] - The presented data highlights the KRAS(ON/OFF) inhibitor CGT1263, which shows selectivity for mutant KRAS over HRAS and NRAS, with picomolar activity across various KRAS mutant cell lines [3] - CGT1815, the prodrug of CGT1263, is designed to enhance human pharmacokinetic performance, demonstrating superior efficacy in tumor growth inhibition studies compared to RMC-6236 [3] Group 2: Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with its most advanced clinical program being bezuclastinib, a selective tyrosine kinase inhibitor targeting the KIT D816V mutation [4] - The company is also conducting a Phase 1 study of a novel FGFR2/3 inhibitor and developing therapies targeting mutations in ErbB2, PI3Kα, and KRAS [4]