Core Insights - A significant insider sale of 3,500,000 shares by Fairmount Funds Management LLC occurred despite Cogent Biosciences achieving its best annual performance in 2025, raising questions about the motivations behind the sale [1][6]. Transaction Summary - Fairmount Funds Management LLC sold 3,500,000 shares for approximately $127.4 million, reducing its indirect holdings by 38.87% to 5,503,418 shares [2][3]. - The shares were sold at a reported price of $36.40, which was lower than the closing price of $39.53 on the same day [3]. Company Overview - Cogent Biosciences, based in Massachusetts, is a clinical-stage biotechnology company focused on targeted therapies for rare, genetically driven diseases, with a market capitalization of $5.46 billion and a net income of -$294.37 million [4][5]. - The company's stock experienced a remarkable 286.13% price increase over the past year, with a notable rise of approximately 342% in 2025 [4][6]. Investor Implications - The sale of shares by Fairmount Funds Management, which generated over $120 million, may indicate profit-taking following substantial stock gains, although the specific motivations remain unclear [6]. - Fairmount Funds continues to hold approximately 67,414 units of Series A Convertible Preferred Stock, which could convert to about 16.85 million common shares, subject to ownership limits [7][8].

Pfizer Inc. (NYSE:PFE) shares are trading higher on Tuesday, as the stock benefits from a price forecast increase at Cantor Fitzgerald. The firm raised its forecast to $27 from $24, providing a catalyst for the pharmaceutical giant even as the broader healthcare sector declined 1.6% during the session.The move stands out against mixed market performance, with the S&P 500 gaining 0.42% and the Nasdaq climbing 0.89%, while the Dow Jones Industrial Average fell 1.01%.Recent Developments Supporting PfizerPfizer ...

Core Insights - Cogent Biosciences has received Breakthrough Therapy Designation from the FDA for bezuclastinib in combination with sunitinib for patients with imatinib-resistant Gastrointestinal Stromal Tumors (GIST) [2][3] - The company plans to submit the New Drug Application (NDA) under the Real-Time Oncology Review (RTOR) program, aiming for completion by April 2026 [1][3] Clinical Trial Results - The PEAK trial demonstrated a 50% reduction in the risk of disease progression or death compared to the current standard of care, with a hazard ratio of 0.50 (95% CI: 0.39 – 0.65) [2] - Median progression-free survival (mPFS) was reported as 16.5 months for the bezuclastinib combination versus 9.2 months for sunitinib monotherapy [2] Future Plans - Cogent intends to present full results from the PEAK trial at a major medical meeting in the first half of 2026 [4] - The company expects to initiate a Phase 2 trial in mid-2026 to investigate the bezuclastinib and sunitinib combination for first-line GIST patients with exon 9 mutations [4] 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 [5] - The company is also developing a portfolio of targeted therapies aimed at various mutations, including FGFR2/3, ErbB2, PI3Kα, KRAS, and JAK2 [5]

Core Insights - The PEAK trial is the first study to show statistical significance over an active comparator in GIST patients, with the combination of bezuclastinib and sunitinib achieving a median progression-free survival (mPFS) of 16.5 months and an overall response rate (ORR) of 46% in patients previously treated with imatinib [1][2] Group 1: FDA Approval and Clinical Trial Results - The FDA has accepted Cogent Biosciences' New Drug Application (NDA) for bezuclastinib in combination with sunitinib for GIST patients who have received prior treatment with imatinib under the Real-Time Oncology Review (RTOR) program [1][4] - The bezuclastinib combination demonstrated a 50% reduction in the risk of disease progression or death compared to the current standard of care, with a hazard ratio of 0.50 (95% CI: 0.39 – 0.65) [2] - The mPFS for the bezuclastinib combination was 16.5 months compared to 9.2 months for sunitinib monotherapy, and the ORR was 46% for the bezuclastinib combination versus 26% for sunitinib [2] Group 2: Future Plans and Trials - Cogent is expected to initiate the RTOR process immediately, with the completion of the NDA submission anticipated in April 2026 [1][4] - Full results from the PEAK trial will be presented at a major medical meeting in the first half of 2026 [5] - A Phase 2 trial is expected to begin in mid-2026 to investigate the benefit of the bezuclastinib combination for first-line GIST patients with exon 9 mutations who are naive to or have recently started treatment with imatinib [5] Group 3: Company Overview - Cogent Biosciences is focused on developing precision therapies for genetically defined diseases, with bezuclastinib being a selective tyrosine kinase inhibitor targeting the KIT D816V mutation and other mutations in KIT exon 17 [6] - The company is also developing a portfolio of novel targeted therapies aimed at various mutations, including FGFR2/3, ErbB2, PI3Kα, KRAS, and JAK2 [6]

-  PEAK trial first ever study to demonstrate statistical significance over an active comparator in GIST patients, with bezuclastinib plus sunitinib combination demonstrating mPFS of 16.5 months and ORR of 46% in patients who had received prior treatment with imatinib  -  Cogent is expected to initiate the RTOR process immediately; completion of the PEAK NDA submission expected in April 2026 WALTHAM, Mass. and BOULDER, Colo., Jan. 20, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biote ...

Core Insights - The presentation is part of the 44th Annual JPMorgan Healthcare Conference, featuring Cogent Biosciences and its CEO, Andy Robbins [1] - The focus of the discussion is on the future of Cogent, particularly looking ahead to developments in 2026 and beyond [3] Company Overview - Cogent's lead asset, bezuclastinib, is a potent and selective KIT mutant inhibitor [3] - In 2025, Cogent reported positive results from three pivotal trials for bezuclastinib, marking a significant year for the company and its patients [3]

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Cogent Biosciences FY Conference Summary Company Overview - **Company**: Cogent Biosciences (NasdaqGS:COGT) - **Lead Asset**: Bezuclastinib, a potent and selective KIT mutant inhibitor - **Focus**: Treatment of gastrointestinal stromal tumors (GIST) and systemic mastocytosis Key Points Industry and Market Opportunity - **Market Size**: The combined annual opportunity for non-advanced systemic mastocytosis and advanced systemic mastocytosis is approximately **$8 billion** [5] - **Competition**: Limited competition exists, primarily from Sanofi's Ayvakit for systemic mastocytosis and no competition in second-line GIST [5][10] - **Second-Line GIST Market**: Expected to be a **$4 billion** market with about **6,000 patients** annually becoming resistant to imatinib [10] Clinical Trials and Regulatory Submissions - **Pivotal Trials**: Three pivotal trials for bezuclastinib were positive in 2025, leading to NDA submissions: - **SUMMIT**: Non-advanced systemic mastocytosis (NDA submitted December 2025) - **PEAK**: GIST (NDA expected in April 2026) - **APEX**: Advanced systemic mastocytosis (NDA to follow PEAK) [2][3] - **Expected Launch**: Anticipated launch in the U.S. in the second half of 2026 for at least the non-advanced systemic mastocytosis indication [3] Financial Position - **Cash Reserves**: Approximately **$900 million** on the balance sheet, providing a cash runway into 2028 [4] - **Profitability Outlook**: Positioned to discuss profitability based on the timing of commercializations [4] Intellectual Property - **Patent Protection**: Strong intellectual property position with protection extending into the mid-2040s, including composition of matter and formulation patents [6][7] Clinical Efficacy - **GIST Trial Results**: - **Median Progression-Free Survival**: **16.5 months** - **Objective Response Rate**: Nearly **50%**, significantly higher than historical drugs [8][9] - **Symptomatic Improvement**: Notable improvements in overall symptoms and mast cell burden in systemic mastocytosis patients [11][12] Commercial Strategy - **Commercial Organization**: Building a team of approximately **100 employees** focused on access and patient community engagement [22][23] - **Expanded Access Program**: Ongoing program to provide access to bezuclastinib for patients, enhancing experience prior to full commercial launch [21] Future Developments - **Pipeline Expansion**: Plans to initiate trials for additional indications, including first-line GIST and combination therapies [18][19] - **New Assets**: Development of a selective JAK2 V617F inhibitor and a pan-KRAS inhibitor, with IND filings expected in 2026 [25][26] Pricing Strategy - **Benchmarking**: Pricing will be informed by existing KIT inhibitors, with current benchmarks around **$41,000 to $46,000** per month [39][40] International Expansion - **Partnerships**: Actively exploring partnerships for commercialization outside the U.S., particularly in Europe and other regions [41][42] Conclusion Cogent Biosciences is positioned for significant growth with its lead asset, bezuclastinib, targeting substantial market opportunities in rare diseases. The company is on track for multiple NDA submissions and a potential launch in 2026, backed by a strong financial position and a robust clinical pipeline.

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 ...

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]