Galectin Therapeutics (NASDAQ: GALT) 8-K Filing Reveals Positive Results from NAVIGATE Trial

Galectin Therapeutics Inc., a clinical-stage biopharmaceutical company, recently disclosed details of its Annual Meeting of Stockholders in a Form 8-K filing with the Securities and Exchange Commission. The meeting, held on January 23, 2025, showcased promising developments following the completion of the NAVIGATE trial.

During the presentation, Galectin Therapeutics highlighted significant achievements in its development program. The company expressed gratitude to trial participants, investigators, staff, consultants, and the Board for their support throughout the program. The pivotal milestone of presenting top-line data from the NAVIGATE trial by the end of 2024 was recognized as a groundbreaking achievement.

The NAVIGATE trial, a global study conducted across five continents with over 100 participating centers, focused on patients with cirrhosis caused by NASH that had progressed to include portal hypertension. Galectin Therapeutics reported that the 2mg drug arm outperformed the placebo by approximately 49% in the per protocol population, demonstrating a favorable clinical effect. The company also observed reductions in varices incidence and supportive results in non-invasive biomarkers of fibrosis.

In addition, the safety profile of belapectin, the drug candidate under investigation, continued to appear favorable during the trial, with no drug-related serious adverse events reported. The company is actively analyzing the data, with plans to complete the evaluation of all 18-month results, the available 36-month dataset, and specialized biomarkers of fibrosis analyses by the end of the current quarter.

Following the presentation of initial findings at a MASH-focused conference, Galectin Therapeutics intends to share data at upcoming major congresses. Positive feedback from key opinion leaders underscores the critical need for effective treatments in patients with MASH cirrhosis and portal hypertension. The company aims to address this unmet medical need with belapectin.

Galectin Therapeutics expressed optimism about the trial data from NAVIGATE, with plans to meet with the FDA in the first half of 2025 to discuss the results and determine the next steps in the development of belapectin. The company looks forward to demonstrating the compelling results and discussing potential partnerships based on the impressive outcomes of the trial.

In conclusion, Galectin Therapeutics remains dedicated to advancing science and delivering new therapies for patients with liver-related conditions. The company’s progress in the NAVIGATE trial marks a significant step towards addressing the urgent medical needs of individuals with cirrhosis caused by NASH.

Please note that the information provided in this report is not filed for purposes of Section 18 of the Securities Exchange Act of 1934 or incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act.

This concludes the summary of Galectin Therapeutics’ 8-K filing regarding the Annual Meeting of Stockholders and the NAVIGATE trial results.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Galectin Therapeutics’s 8K filing here.

About Galectin Therapeutics

Galectin Therapeutics Inc, a clinical stage biopharmaceutical company, engages in the research and development of therapies for fibrotic, cancer, and other diseases. Its lead product candidate is belapectin (GR-MD-02) galectin-3 inhibitor, that is in Phase 2b/3 clinical trial, to prevent esophageal varices in patient with non-alcoholic steatohepatitis (NASH) cirrhosis; and Phase 2 clinical trial for the treatment of liver fibrosis, as well as severe skin disease, and melanoma and head and neck squamous cell carcinoma.