Galectin Therapeutics

Galectin Therapeutics announced it will evaluate belapectin in a registration‑enabling phase III study in patients with NASH cirrhosis and portal hypertension, and has selected the 2 mg dose as the investigational arm. NAVIGATE phase IIb data showed a 43.2% reduction in new esophageal varices in the intent‑to‑treat analysis for 2 mg versus placebo and positive biomarker signals for liver stiffness and fibrosis markers. No drug‑related serious adverse events or drug‑induced liver injury were reported, leading the company to highlight the safety profile and an estimated meaningful U.S. market potential of about 3.3 million patients. Galectin plans to submit the phase III protocol in line with FDA alignment and is seeking partnerships for further development. » More on de.investing.com

Galectin Therapeutics has added Dr. Henry Brem as an independent member of its board of directors; Brem holds the Henry Brem Professorship of Neurosurgery at Johns Hopkins University and co-developed image-guided surgical techniques and local drug-delivery systems. The company is developing Belapectin to inhibit Galectin-3; the program for metabolic dysfunction-associated steatohepatitis with cirrhosis has FDA Fast Track status. The stock returned 97.5% last year but is down 23.6% year-to-date, and analysts point to a lack of profitability and short-term liabilities exceeding cash. » More on de.investing.com

Marc Rubin has resigned his mandate on the board of Galectin Therapeutics effective January 10; the company emphasizes the resignation was not due to disagreements over business operations. Galectin received written feedback from the FDA on Belapectin and plans a follow-up Type C meeting, with target patients for a registration study assessed as consistent, but key study-design questions still open. New biomarker analyses from the NAVIGATE study suggest antifibrotic effects of Belapectin and a lower rate of new varices. At the 2025 annual general meeting, all nominated directors were re-elected. » More on de.investing.com