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 ...

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 - Cogent Biosciences Inc. (NASDAQ:COGT) has seen a significant increase in its stock value, with a notable upward revision of its price target from $21 to $50 by H.C. Wainwright, reaffirming a Buy rating [1][2] - The positive outlook is primarily driven by the results of the Phase 3 PEAK trial, which indicates that the combination of bezuclastinib and sunitinib could become the second-line standard of care for gastrointestinal stromal tumors (GIST) [2][3] - Following the announcement of the trial results, Cogent's shares surged by 119% on the day of the announcement [3] Company Developments - Cogent Biosciences announced the positive results of the Phase 3 PEAK trial on November 10, 2025, and plans to submit a new drug application (NDA) to the U.S. FDA for bezuclastinib in GIST in the first half of 2026 [3][4] - The trial results showed a greater than seven-month improvement in median progression-free survival (mPFS), effectively reducing the rate of progression or death by half for patients with imatinib-resistant or intolerant GIST [4] Industry Context - The results of the PEAK study are seen as a significant advancement for GIST patients, particularly those who have been waiting for nearly 20 years for a new second-line treatment option [4] - The company focuses on developing precision therapies for genetically defined diseases, with a primary emphasis on mastocytosis and gastrointestinal stromal tumors (GIST) [4]

Core Insights - Cogent Biosciences (COGT) shares have surged 120.3% in one month, primarily due to positive data from a late-stage study of its investigational therapy combining bezuclastinib and sunitinib for second-line gastrointestinal stromal tumors (GIST) patients [1][5] - The phase III PEAK study demonstrated a 50% reduction in the risk of disease progression or death, with a median progression-free survival (PFS) of 16.5 months compared to 9.2 months for sunitinib monotherapy [2][5] - The combination therapy achieved a 46% objective response rate (ORR), significantly higher than the 26% ORR for sunitinib alone, indicating superior antitumor activity [3][5] - COGT plans to submit a regulatory filing to the FDA for the bezuclastinib/sunitinib combination in the first half of 2026, aiming to establish it as the new standard of care for GIST [7] Study Data Summary - The bezuclastinib/sunitinib combination showed a statistically significant clinical benefit on the primary endpoint of PFS, with a 50% reduction in disease progression risk [2] - The treatment was well tolerated, with no new safety risks identified compared to sunitinib's established profile, and most treatment-related adverse events were mild to moderate [6] Pipeline Overview - Bezuclastinib is the lead candidate for Cogent Biosciences, with ongoing evaluations for two systemic mastocytosis (SM) indications in separate phase III studies [8] - Positive top-line data from a late-stage study for non-advanced SM patients was reported, with plans to submit a new drug application to the FDA by the end of 2025 [9][11] - The company is also conducting a pivotal phase III study for advanced SM, with top-line results expected in December 2025 [12] Market Performance - Year-to-date, COGT shares have increased by 347.9%, significantly outperforming the industry growth of 15.8% [4]

Core Insights - Cogent Biosciences, Inc. (NASDAQ:COGT) experienced a significant stock increase of 126.3% week-on-week due to positive clinical trial results for its drug candidate targeting Gastrointestinal Stromal Tumors (GIST) [1][5] Company Developments - Cogent Biosciences plans to file a new drug application with the FDA for its treatment candidate, bezuclastinib, in combination with sunitinib, following promising phase 3 trial results [2] - The phase 3 trial indicated that patients taking bezuclastinib with sunitinib had an average of 16.5 months without cancer progression, compared to 9.2 months for those on sunitinib alone [3] - Additionally, 46% of patients on the combination therapy experienced tumor shrinkage, versus 26% for those on sunitinib alone [3] Management Commentary - The President and CEO of Cogent Biosciences, Andrew Robbins, stated that the trial results exceeded expectations, highlighting a greater than seven-month improvement in median progression-free survival (mPFS) and a reduction in the rate of progression or death by half [4] Financial Strategy - Following the positive trial results, Cogent Biosciences announced plans to raise $200 million through convertible senior notes due 2031, with $50 million allocated to repay outstanding loans and the remainder for development and regulatory activities related to bezuclastinib and other drug candidates [5]

Cogent Biosciences (NasdaqGS:COGT) Update Summary Company Overview - **Company**: Cogent Biosciences - **Focus**: Development of beziclassinib for the treatment of gastrointestinal stromal tumors (GIST) and systemic mastocytosis Key Industry Insights - **Market Size**: The global market for GIST treatments is estimated at **$7.5 billion** annually, with significant potential for beziclassinib due to limited competition [4][32] - **Current Treatment Landscape**: Existing FDA-approved treatments for imatinib-resistant GIST include sunitinib, regorafenib, and ripretinib, with modest efficacy (median progression-free survival of **5-6 months**) [5][8] Core Findings from the Phase 3 Peak Trial - **Trial Results**: The combination of beziclassinib and sunitinib demonstrated a **16.5-month median progression-free survival (PFS)**, a **46% objective response rate**, and a **50% reduction in the risk of progression or death** compared to sunitinib alone [3][14][27] - **Statistical Significance**: The results were statistically significant with a p-value of less than **0.001** [15] - **Safety Profile**: The combination treatment was generally well tolerated, with no new safety risks identified compared to sunitinib alone. Treatment-related adverse events were similar between the two arms [17][20][27] Patient Demographics and Trial Design - **Patient Population**: The trial included **204 patients** receiving the combination and **209 patients** receiving sunitinib alone, with a balanced demographic profile [10][12] - **Eligibility Criteria**: Patients had to be over 18 years old with locally advanced, unresectable, or metastatic GIST and documented disease progression or intolerance to imatinib [11] Efficacy and Response Rates - **Response Rates**: The combination treatment achieved a **46% response rate**, with **6.4%** of patients achieving complete response and **39.2%** achieving partial response [15][16] - **Durability of Response**: The mean treatment duration for patients on the combination is projected to exceed **19 months**, indicating potential long-term benefits [28] Future Plans and Regulatory Pathway - **Regulatory Submission**: Cogent plans to submit a new drug application for beziclassinib in GIST by the **first half of 2026**, with potential approval by the **second half of 2026** if granted priority review [28][29] - **Expanded Access Program**: An active no-cost expanded access program is in place for GIST patients in urgent need of treatment [29] Additional Insights - **Combination Therapy Rationale**: The combination of beziclassinib and sunitinib targets a broader spectrum of KIT mutations, potentially improving treatment outcomes for patients with various resistance mutations [9][10] - **Market Opportunity**: The projected market opportunity for GIST treatments is based on an estimated **3,000 second-line patients** annually in the U.S. and Western Europe, with pricing assumptions based on existing treatments [63] Conclusion Cogent Biosciences is positioned to significantly impact the treatment landscape for GIST with the promising results from the Peak Trial, highlighting the efficacy and safety of beziclassinib in combination with sunitinib. The company is on track for regulatory submissions and is actively working to provide access to this innovative treatment for patients in need.

Core Insights - Cogent Biosciences reported positive results from the Phase 3 PEAK trial of bezuclastinib plus sunitinib in patients with imatinib-resistant or intolerant Gastrointestinal Stromal Tumors (GIST) [2][3] - The combination therapy achieved a median progression-free survival (mPFS) of 16.5 months, significantly higher than the 9.2 months observed with sunitinib monotherapy [2][4] - The objective response rate (ORR) for the bezuclastinib combination was 46%, compared to 26% for sunitinib alone, indicating a substantial improvement in treatment efficacy [2][4] Clinical Trial Results - The PEAK trial demonstrated a 50% reduction in the risk of disease progression or death, with a hazard ratio of 0.50 (95% CI: 0.39 – 0.65) [4] - The trial results are the first positive Phase 3 outcomes for second-line GIST patients in over 20 years, marking a significant milestone in treatment options [2][3] - The estimated mean duration of treatment for the bezuclastinib combination is projected to exceed 19 months [5] Safety Profile - The bezuclastinib combination was generally well tolerated, with no unique risks compared to sunitinib's known safety profile [6] - Common Grade 3+ treatment emergent adverse events included hypertension (29.4% vs. 27.4% for sunitinib), neutropenia (15.2% vs. 15.4%), and ALT/AST increases (10.8% vs. 1.4%) [6] - Discontinuation rates due to treatment-related adverse events were 7.4% for the bezuclastinib combination and 3.8% for sunitinib monotherapy [6] Future Plans - Cogent plans to submit a new drug application (NDA) to the U.S. FDA for bezuclastinib in GIST in the first half of 2026 [2][12] - Detailed results from the PEAK trial will be presented at a scientific conference in the first half of 2026 [2][7] - The company is also preparing for additional presentations and data releases related to its other clinical programs [12]

Core Insights - Cogent Biosciences has secured a debt financing facility of up to $400 million to support its growth strategy, including the anticipated launch of bezuclastinib in 2026 [1][2] - The company is on track to report results from three pivotal trials in 2025, starting with the SUMMIT trial results in July [1][4] Financing Details - An initial tranche of $50 million was drawn at closing, with an additional $100 million available in 2025 based on successful data readouts from SUMMIT and PEAK trials [3] - A further $50 million can be accessed upon achieving early commercial success after the bezuclastinib launch, with the remaining $200 million available through mutual agreement [3] Clinical Trials - The SUMMIT trial is a registration-directed, randomized, double-blind, placebo-controlled study focused on patients with NonAdvSM, with results expected in July 2025 [4] - The APEX trial, an open-label study in patients with AdvSM, is set to release results in the second half of 2025, while the PEAK trial results are expected before the end of 2025 [4] Company Overview - Cogent Biosciences specializes in 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 advancing a Phase 1 study of a novel FGFR2 inhibitor and developing therapies targeting mutations in ErbB2, PI3Kα, and KRAS [6]