-- Bezuclastinib demonstrated rapid and deep clinical benefit in AdvSM patients resulting in an objective response rate (CR+CRh+PR+CI) of 57% per mIWG criteria and 80% per PPR criteria -- -- Bezuclastinib demonstrated a powerful effect on mast cell burden with 89% of patients achieving ≥50% reduction in bone marrow mast cells or clearance of aggregates – -- Bezuclastinib was very well tolerated with only 14.8% of patients requiring dose reduction and no patients requiring discontinuation due to treatment re ...

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]

16.5 months median progression free survival (mPFS) for bezuclastinib plus sunitinib compared to 9.2 months mPFS for sunitinib monotherapy (HR=0.50, CI: 0.39-0.65; p<0.0001) 46% Objective Response Rate (ORR) reported for bezuclastinib combination compared to 26% ORR for sunitinib monotherapy (p<0.0001) Safety profile of bezuclastinib combination was well tolerated with no unique risks observed with the combination when compared to the known safety profile of sunitinib First positive Phase 3 trial in second- ...

Core Insights - Palisade Bio has appointed Sharon Skare, PhD(c), as Vice President, Global Head of Clinical Operations, bringing over 24 years of experience in clinical development across various therapeutic areas [1][3][4] - The company is focused on advancing PALI-2108 for ulcerative colitis and fibrostenotic Crohn's disease, with a Phase 2 IND submission planned for the first half of 2026 [1][7] Company Overview - Palisade Bio is a clinical-stage biopharmaceutical company developing precision therapies for autoimmune, inflammatory, and fibrotic diseases [8] - The company aims to transform the treatment landscape by utilizing a targeted approach with its novel therapeutics [8] Product Development - PALI-2108 is an orally administered prodrug designed for local delivery of phosphodiesterase-4 (PDE4) inhibition specifically to the terminal ileum and colon [5] - The prodrug is engineered to be gut-restricted and pharmacologically inactive until it reaches the lower intestine, where it is activated by bacterial enzymes [5][6] - A Phase 1a/1b study of PALI-2108 for ulcerative colitis has been completed with positive data, and a Phase 1b study for fibrostenotic Crohn's disease is currently underway [7] Leadership and Expertise - Sharon Skare has a strong background in global clinical development, having previously held senior positions at Abivax, Pfizer, and Arena Pharmaceuticals [3][4] - Her experience includes overseeing global Phase 3 and Phase 2 programs in ulcerative colitis and Crohn's disease, as well as leading clinical operations for Etrasimod, now approved as Velsipity™ [3][4]

Core Insights - Palisade Bio has developed PALI-2108, a first-in-class PDE4 inhibitor specifically targeting the terminal ileum and colon for treating fibrostenotic Crohn's disease (FSCD) and ulcerative colitis (UC) to meet significant unmet medical needs [1][4] Intellectual Property - The Canadian Intellectual Property Office has granted patent number 3,174,137 for PALI-2108, providing composition-of-matter protection until May 28, 2041 [2] - The patent covers the unique design of PALI-2108, which includes a galactose-derived sugar moiety that minimizes absorption until activated by colonic bacteria [2] Clinical Development - Palisade Bio is advancing PALI-2108 in a Phase 1b study for FSCD, with patient dosing expected to start in the second half of 2025 and topline data anticipated in the first quarter of 2026 [3] - Results from the Phase 1b study, along with data from completed Phase 1a/1b trials in UC, will support a planned Phase 2 IND submission to the FDA in the first half of 2026 [3] Product Overview - PALI-2108 is an orally administered prodrug designed for gut-restricted delivery, achieving high local tissue concentrations while minimizing systemic exposure [4] - The mechanism of action aims to maximize anti-inflammatory and anti-fibrotic effects while reducing common tolerability issues associated with systemic PDE4 inhibitors [4] Company Background - Palisade Bio is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for autoimmune, inflammatory, and fibrotic diseases [5]

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]