Core Insights - Cogent Biosciences announced additional clinical results from the SUMMIT trial for bezuclastinib in patients with NonAdvanced Systemic Mastocytosis (NonAdvSM), showing significant improvements across primary and secondary endpoints [1][2] Group 1: Clinical Results - Bezuclastinib demonstrated a mean change of -32.0 points in Total Symptom Score (TSS) at 48 weeks, indicating a 56% relative improvement from baseline [5][6] - 99% of patients achieved over 50% reduction in serum tryptase levels, with 83% normalizing their levels [6][11] - Significant improvements were observed across various symptoms, including a 65% reduction in dermatologic symptoms and a 53.6% reduction in neurocognitive symptoms [4][11] Group 2: Safety and Tolerability - Bezuclastinib exhibited a favorable safety and tolerability profile, supporting its potential for chronic use in NonAdvSM patients [7][11] Group 3: Market Position and Future Potential - The company believes bezuclastinib has the potential to become the preferred standard of care for NonAdvSM patients due to its rapid and meaningful symptom improvement [2][10] - The treatment is positioned as the first disease-modifying agent for NonAdvSM, with strong evidence correlating serum tryptase reduction with symptomatic improvement [5][11] Group 4: Inducement Grants - Cogent announced inducement equity awards to three new employees, including nonqualified options to purchase 24,000 shares and 21,000 restricted stock units (RSUs) [8]

SUMMIT NDA for bezuclastinib in patients with NonAdvSM submitted in December 2025; APEX NDA submission for bezuclastinib in patients with AdvSM on track for 1H 2026PEAK NDA initiated for bezuclastinib in patients with 2L GIST under Real-Time Oncology Review (RTOR) and Breakthrough Therapy Designation (BTD); completion of NDA on track for April 2026Six abstracts from SUMMIT trial of bezuclastinib in patients with NonAdvSM accepted for presentation at 2026 AAAAI annual meetingStrong financial position with $9 ...

Core Insights - Cogent Biosciences, Inc. is set to present multiple posters on bezuclastinib results from the SUMMIT trial for NonAdvanced Systemic Mastocytosis at the 2026 AAAAI Annual Meeting [1][2] Group 1: Upcoming Presentations - The posters will cover various aspects of bezuclastinib, including expanded results from the Phase 2 SUMMIT trial, evaluation of bone formation marker changes, patient experiences, symptom burden improvement, and results in subgroups with unmet needs [3] Group 2: Drug Development and Regulatory Status - In December 2025, Cogent submitted a New Drug Application for bezuclastinib to the FDA, based on positive clinical data from the SUMMIT trial and following its Breakthrough Therapy Designation [2] - Bezuclastinib is a selective tyrosine kinase inhibitor targeting the KIT D816V mutation, which is significant in systemic mastocytosis and other related conditions [4] Group 3: Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases and has an ongoing Phase 1 study of a novel FGFR2/3 inhibitor [4][5]

Company Overview - Cogent Biosciences, Inc. is a biotechnology company focused on developing precision therapies for genetically defined diseases [3] - The company is based in Waltham, MA and Boulder, CO [3] Key Developments - Andrew Robbins, President and CEO, will present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026 [1] - A live webcast of the presentation will be available on the Investors & Media page of Cogent's website, with a replay accessible for 30 days post-event [2] Clinical Programs - The most advanced clinical program is bezuclastinib, a selective tyrosine kinase inhibitor targeting 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 internally discovered FGFR2/3 inhibitor [3] - Cogent is developing a portfolio of targeted therapies aimed at mutations in ErbB2, PI3Kα, KRAS, and JAK2 [3]

Core Insights - Cogent Biosciences has submitted a New Drug Application (NDA) for bezuclastinib to the FDA for NonAdvanced Systemic Mastocytosis (NonAdvSM), based on positive results from the SUMMIT pivotal trial [1][2] - The NDA submission is part of a broader strategy, with two additional submissions planned for bezuclastinib targeting Gastrointestinal Stromal Tumors (GIST) and Advanced Systemic Mastocytosis (AdvSM) in the first half of 2026 [5] Group 1: Clinical Data and Trial Results - The SUMMIT trial achieved statistical significance across all primary and key secondary endpoints, demonstrating the efficacy of bezuclastinib in patients with NonAdvSM [2] - Bezuclastinib showed significant clinical benefits across 11 individual patient-reported symptoms, with reductions in serum tryptase correlating with symptom severity improvements [3] - Updated data from the SUMMIT trial indicated a continued deepening of symptomatic improvement over 48 weeks, suggesting potential for sustained clinical benefits with longer therapy duration [4] Group 2: Regulatory Designation and Future Plans - Bezuclastinib received Breakthrough Therapy Designation from the FDA in October 2025, highlighting its potential to meet significant unmet medical needs [5] - The company plans to submit NDAs for bezuclastinib in GIST and AdvSM based on strong clinical results from the PEAK and APEX trials, expected in the first half of 2026 [5] Group 3: Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with bezuclastinib being a selective tyrosine kinase inhibitor targeting the KIT D816V mutation [6] - The company is also engaged in developing a portfolio of novel targeted therapies for serious, genetically driven diseases, including ongoing studies for FGFR2/3 inhibitors [6]

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]

Core Insights - Cogent Biosciences, Inc. announced multiple presentations for bezuclastinib at the upcoming 67th Annual Meeting of the American Society of Hematology (ASH), highlighting its potential as a best-in-class treatment for NonAdvanced Systemic Mastocytosis (NonAdvSM) [1][2] - The company is also set to present a novel JAK2 V617F mutant-selective inhibitor, which is expected to be on track for an Investigational New Drug (IND) application in 2026 [1][2] Presentation Details - Bezuclastinib will be featured in two oral presentations at ASH, focusing on its efficacy and safety results from the pivotal Summit trial in adults with NonAdvSM [3] - The first oral presentation will take place on December 6, 2025, at 9:45 AM ET, presented by Dr. Lindsay Rein [3] - The second oral presentation will discuss the effects of bezuclastinib on mastocytosis pathobiology, scheduled for December 8, 2025, at 5:00 PM ET, presented by Dr. Tracy George [4] Additional Research - A poster presentation will explore the relationship between KIT inhibition by bezuclastinib and its effects on disease burden in mouse models of systemic mastocytosis, scheduled for December 8, 2025 [5] - Preclinical data on the novel JAK2 V617F mutant-selective inhibitor will also be presented in a poster session on December 7, 2025 [6] Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with bezuclastinib being a selective tyrosine kinase inhibitor targeting the KIT D816V mutation, which drives systemic mastocytosis [7] - The company is also developing a portfolio of targeted therapies aimed at various mutations, including FGFR2/3, ErbB2, PI3Kα, KRAS, and JAK2 [7]

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]