Galectin plans to submit the final trial protocol to the FDA in the third quarter of 2026.
- CEO Joel Lewis said the agreement provides “important clarity” and renewed confidence as the company advances the program while exploring strategic partnerships.
- Belapectin is an investigational drug that targets galectin-3 protein to reduce liver inflammation and scarring.
- On Stocktwits, retail sentiment around GALT jumped from ‘bearish’ to ‘bullish’ over the past 24 hours.
Shares of Galectin Therapeutics Inc. (GALT) jumped 22% on Tuesday after the company said that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on a planned late-stage trial for belapectin in patients with MASH cirrhosis and portal hypertension, giving the company a clearer roadmap to potential marketing approval.
The stock is on track to clock its best day since June 2025, if the gains hold.
What GALT’s Late-stage Trial Will Look Like
MASH cirrhosis is advanced liver scarring from fatty liver disease, while portal hypertension is dangerously high blood pressure in the liver’s veins. Together, they sharply raise the risk of life-threatening bleeding from enlarged veins called varices.
Galectin’s trial will evaluate a single 2 mg dose of belapectin in patients with these conditions. The main goal will be to prevent esophageal varices.
The study will use the same centralized, blinded endoscopy review process successfully employed in an earlier trial and is expected to be similar in size. Galectin plans to submit the
final protocol to the FDA in the third quarter of 2026.
CEO Joel Lewis said the agreement provides “important clarity” and renewed confidence as the company advances the program while exploring strategic partnerships.
Background And Next Steps
Belapectin is an investigational drug that targets galectin-3 protein to reduce liver inflammation and scarring. Data from an earlier trial showed it reduced the development of varices in high-risk MASH cirrhosis patients.
Galectin is now preparing for the late-stage study and seeking partnerships to support development. The company emphasized that approval in this population would follow the traditional full-approval pathway rather than accelerated approval.
How Did GALT Retail Traders React?
On Stocktwits, retail sentiment around GALT jumped from ‘bearish’ to ‘bullish’ territory over the past 24 hours, while message volume rose from ‘normal’ to ‘high’ levels.
A Stocktwits user expressed optimism for a partnership announcement soon.
Yet another voiced optimism on the market potential of belapectin.
GALT stock has fallen 11% year-to-date.
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