GALECTIN THERAPEUTICS INC
For the period ended Aug 14, 2026. Filed Aug 14, 2026.
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A notice of a major event between regular reports, such as results, a deal or a change of executives. It is often the first formal record of the news.
Aug 14, 2026 · Filed Aug 14, 2026
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GALT$3.14+5.2%Stored close · as of Nov 6, 2026
Contents
EX-99.1 · Belapectin Program Highlights
Belapectin Program Highlights
Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of Metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis.
MASH Cirrhosis
| • | Reached agreement with the U.S. Food and Drug Administration (FDA) on the path forward for the potential full approval of belapectin. Alignment was reached with the agency on the key elements of the planned Phase 3 trial design, including the primary endpoint of composite liver outcome, blinded central review process for endoscopic assessment of esophageal varices, and the use of a single, 2 mg/kg LBM dose of belapectin. |
| • | Presented oral and poster presentations of new analyses from its global NAVIGATE Phase 2b/3 trial of belapectin at the European Association for the Study of the Liver (EASL) Congress 2026: |
| • | The oral presentation, presented by Mazen Noureddin, MD, MHSc, Director of Houston Research Institute and Professor of Medicine at Houston Methodist Hospital, showed belapectin’s impact on fibrosis modulation in patients with high-risk MASH cirrhosis, as reflected by changes in the Pro-C3/CTX-III ratio — a marker of fibrogenesis balance. Favorable shifts in this ratio were associated with reduced varices development and improvements in broad markers of fibrosis including liver stiffness measurement and other markers of fibrosis including Pro-C3, supporting belapectin’s potential to modify disease progression by targeting underlying fibrotic pathology. |
| • | The poster presentation, presented by Naim Alkhouri, MD, FAASLD, Chief Academic Officer at Summit Clinical Research and Director of the Steatotic Liver Program at North Shore Gastroenterology, included new analyses from the NAVIGATE trial demonstrating risk reduction in clinically significant portal hypertension. Notably, this abstract has been designated a TOP Poster by EASL, recognizing it among the best abstracts in the Portal Hypertension (cirrhosis and non-cirrhosis) session. |
| • | Published in AASLD flagship journal Hepatology a manuscript titled “Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in Patients with MASH Cirrhosis: The Randomized, Placebo-Controlled NAVIGATE Trial”. The publication highlights the results from the NAVIGATE Phase 2b clinical trial evaluating belapectin in patients with MASH cirrhosis and portal hypertension. |
| • | Published in Gastro Hep Advances a manuscript titled “Assessment of Esophageal and Gastric Varices in Patients With Cirrhosis for Clinical Trials: A Centralized Blinded Evaluation System”. The publication describes Galectin’s novel central endoscopy review process used in the NAVIGATE trial that will also be utilized in the planned registrational Phase 3 study. |
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