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 at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 13, 2026 at 8:15 a.m. PT/11:15 a.m. ET. A live webcast will be available on the Investors & Media page of Cogent’s website ...

WALTHAM, Mass. and BOULDER, Colo., Dec. 30, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM). The submission is based on positive clinical data from the SUMMIT pivotal trial and follows the Breakthrough Therapy Designa ...

Core Viewpoint - Cogent Biosciences, Inc. has initiated public offerings totaling $400 million, comprising $200 million in convertible senior notes and $200 million in common stock to support its operations and product development [1][5]. Offering Details - The company is offering $200 million in convertible senior notes due 2031 and $200 million in common stock, with underwriters granted a 30-day option to purchase an additional $30 million in each offering [1][2]. - The convertible notes will be unsecured, with interest payable semi-annually, maturing on November 15, 2031, and can be converted into cash, shares, or a combination thereof [4]. Use of Proceeds - Net proceeds from the offerings will be allocated to repay $50 million in existing loans, development and regulatory activities for bezuclastinib and other candidates, and general corporate purposes [5]. Management and Underwriters - Jefferies and J.P. Morgan are the joint book-running managers for the convertible notes offering, while multiple firms including J.P. Morgan and Jefferies are managing the equity offering [6]. Regulatory Compliance - The offerings will be conducted under an automatic shelf registration statement filed with the SEC, which became effective upon filing [7].

Core Insights - Cogent Biosciences is approaching significant milestones with the upcoming top-line results from the Phase 3 PEAK trial in November 2025 and the APEX trial in December 2025 [1][4][13] - The company has received Breakthrough Therapy Designation for bezuclastinib, which is on track for a New Drug Application (NDA) submission for NonAdvanced Systemic Mastocytosis (NonAdvSM) by the end of 2025 [1][5][12] - Cogent has a strong cash position of $430 million, expected to fund operations through the anticipated launch of bezuclastinib and into 2027 [1][6] Recent Business Highlights - The company reported positive top-line results from the SUMMIT trial, achieving statistical significance across all primary and key secondary endpoints for NonAdvSM patients [5] - Cogent plans to present multiple abstracts at the 67th Annual Meeting of the American Society of Hematology (ASH) in December 2025, including two oral presentations on SUMMIT data [1][5][2] - The company has received FDA clearance for its Investigational New Drug (IND) submission for CGT4255, a novel ErbB2 inhibitor, with a Phase 1 trial set to begin in November [5] Financial Overview - As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $390.9 million, an increase from $345.5 million as of June 30, 2025 [6] - Research and development expenses for Q3 2025 were $69.0 million, up from $63.6 million in Q3 2024, primarily due to ongoing clinical trials [7] - General and administrative expenses rose to $14.4 million in Q3 2025 from $11.8 million in Q3 2024, reflecting organizational growth [8] - The net loss for Q3 2025 was $80.9 million, compared to a net loss of $70.6 million for the same period in 2024 [9]

SUMMIT data for bezuclastinib in NonAdvSM selected for two oral presentations which will describe its best-in-class potential Novel JAK2 V617F mutant-selective inhibitor announced as Cogent’s newest preclinical program; on-track for IND in 2026 WALTHAM, Mass. and BOULDER, Colo., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced three presentations featuring bezuclastin ...

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]

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]

Core Insights - Cogent Biosciences, Inc. announced the approval of inducement equity awards for 10 new employees as part of its 2020 Inducement Plan, in compliance with Nasdaq corporate governance rules [1][2] Group 1: Inducement Equity Awards - The Compensation Committee approved nonqualified options to purchase a total of 299,200 shares of Cogent common stock for the new employees [2] - Each option has a 10-year term with an exercise price equal to the closing price on the grant date, and a four-year vesting schedule [2] 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 [3] - Bezuclastinib targets the KIT D816V mutation, which is linked to systemic mastocytosis and advanced gastrointestinal stromal tumors (GIST) [3] - 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 [3]

Core Viewpoint - Cogent Biosciences, Inc. has successfully closed an upsized underwritten public offering of 25,555,556 shares of common stock at a price of $9.00 per share, raising approximately $230 million in gross proceeds [1][2]. Group 1: Offering Details - The offering included 3,333,333 shares from the underwriters' option to purchase additional shares [1] - The net proceeds will be utilized for the development and commercial preparation of bezuclastinib and other product candidates, as well as for working capital and general corporate purposes [2]. - J.P. Morgan, Leerink Partners, and Guggenheim Securities served as joint book-running managers for the offering [2]. Group 2: Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with its leading clinical program being bezuclastinib, a selective tyrosine kinase inhibitor targeting the KIT D816V mutation [6]. - The company is also conducting a Phase 1 study of a novel FGFR2 inhibitor and is developing therapies targeting mutations in ErbB2, PI3Kα, and KRAS [6].

Core Viewpoint - Cogent Biosciences, Inc. has announced a public offering of 22,222,223 shares of common stock at a price of $9.00 per share, aiming to raise approximately $200 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The offering includes a 30-day option for underwriters to purchase an additional 3,333,333 shares on the same terms [1]. - The expected closing date for the offering is around July 10, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for the development, regulatory, and commercial preparation activities related to bezuclastinib and other product candidates [2]. - Funds will also support the planned commercial launch of bezuclastinib, along with working capital and general corporate purposes [2]. Group 3: Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with bezuclastinib being the most advanced clinical program [5]. - Bezuclastinib is a selective tyrosine kinase inhibitor targeting the KIT D816V mutation, which is associated with systemic mastocytosis and advanced gastrointestinal stromal tumors [5]. - The company is also conducting a Phase 1 study of a novel FGFR2 inhibitor and developing therapies targeting mutations in ErbB2, PI3Kα, and KRAS [5].