On February 17, 2026, Rock Springs Capital Management disclosed in a U.S. Securities and Exchange Commission (SEC) filing that it sold 159,278 shares of Cogent Biosciences (NASDAQ:COGT), an estimated $4.48 million trade based on quarterly average pricing. What happened According to its SEC filing dated February 17, 2026, Rock Springs Capital Management LP reduced its stake in Cogent Biosciences by 159,278 shares during the fourth quarter. The estimated transaction value was $4.48 million, calculated from ...

On February 13, 2026, First Turn Management disclosed a new position in Cogent Biosciences (NASDAQ:COGT), acquiring 824,283 shares worth $29.28 million at quarter’s end. What happened According to a recent SEC filing dated February 13, 2026, First Turn Management disclosed a new purchase of 824,283 shares of Cogent Biosciences. The fund reported the new position at quarter end, with the value reflecting both the initial investment and any market price changes during the period. What else to know This ...

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]

Core Insights - Pfizer Inc. shares are experiencing an increase due to a price forecast raise by Cantor Fitzgerald from $24 to $27, despite a decline in the broader healthcare sector [1] Recent Developments Supporting Pfizer - Pfizer has entered a non-exclusive licensing agreement with Novavax Inc. for the Matrix-M adjuvant technology, which includes a $30 million upfront payment and potential milestones totaling up to $500 million [2] - Pfizer's drug Sutent, used for gastrointestinal stromal tumors, has received FDA Breakthrough Therapy Designation in combination with Cogent Biosciences' bezuclastinib, showing a 50% reduction in disease progression risk [3] Leadership Commentary - Pfizer CEO Albert Bourla highlighted at the World Economic Forum that reduced funding for U.S. universities is weakening America's position in global health research, with Chinese institutions now holding about 80% of top-tier positions in health research rankings [4] Earnings & Analyst Outlook - Investors are anticipating the next earnings report scheduled for February 3 [5] Benzinga Edge Rankings - Pfizer shares were up 2.14% at $26.43, with an EPS estimate of $0.57 (down from $0.63 YoY) and a revenue estimate of $16.83 billion (down from $17.76 billion YoY) [6] - The company has a P/E ratio of 15.0x, indicating fair valuation, and is trading at a premium relative to peers with a value score of 34.84 [6] - The balance sheet remains healthy with a quality score of 54.07, but the stock is underperforming the broader market with a momentum score of 29.54 [6]

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]

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: Safety and Future Plans - The bezuclastinib combination was generally well tolerated, with no unique risks observed compared to the known safety profile of sunitinib [3] - Cogent plans to present full results from the PEAK trial at a major medical meeting in the first half of 2026 and will initiate a Phase 2 trial in mid-2026 for first-line GIST patients with exon 9 mutations [5][8] 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 targeted therapies aimed at various mutations, including FGFR2/3, ErbB2, PI3Kα, KRAS, and JAK2 [6]

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]

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.