Galectin Therapeutics formalized its late-stage clinical programme for belapectin on Thursday, one day after the U.S. Food and Drug Administration cleared a regulatory path for the trial. The Norcross, Georgia-based biotechnology company said it would proceed with a protocol submission.

Shares in Galectin (GALT) surged 22% on Wednesday in their strongest single-day move in more than a year. The FDA's clearance addressed a key uncertainty that had weighed on the small-cap firm's prospects for years.

Belapectin is a galectin-3 inhibitor being developed to prevent the development of oesophageal varices in patients with non-alcoholic steatohepatitis, or NASH, cirrhosis with portal hypertension. The company has previously reported mixed data from earlier-stage studies, and the new trial aims to deliver the confirmatory evidence regulators require for approval.

The outcome carries significant weight for patients with advanced liver disease, a population with few approved therapies. Analysts said the FDA's willingness to define a registrational pathway reduces the binary risk that has long surrounded Galectin's single lead asset.

A Galectin spokesperson said the company intended to finalise trial design and site planning in the coming weeks. The firm will provide further detail on funding and timelines for the study.