Galectin Therapeutics Publishes Belapectin Clinical Trial Results
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 11 2026
0mins
Galectin Therapeutics announced the publication of results from its NAVIGATE Phase 2b clinical trial evaluating belapectin in patients with MASH cirrhosis and portal hypertension in AASLD flagship journal Hepatology. "These results further strengthen the clinical and mechanistic profile of belapectin in MASH cirrhosis and portal hypertension," said Khurram Jamil, chief medical officer of Galectin Therapeutics. "The consistency across clinical outcomes and noninvasive biomarkers, including signals of reduced risk of clinically significant portal hypertension and variceal development, reinforces our confidence in belapectin's potential to modify disease progression. We believe these data meaningfully support continued advancement of our program, while positioning belapectin as a differentiated therapeutic candidate in MASH cirrhosis with portal hypertension-a market with significant unmet need and limited treatment options."
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About GALT
Galectin Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to developing therapies to improve the lives of patients with chronic liver disease and cancer. The Company’s drug candidates are based on its method of targeting galectin proteins, which are key mediators of biologic and pathologic functions. The Company’s lead drug, belapectin, is a carbohydrate-based drug that inhibits the galectin-3 protein, which is directly involved in multiple inflammatory, fibrotic, and malignant diseases for which it has Fast Track designation by the U.S. Food and Drug Administration. The lead development program is in metabolic dysfunction-associated steatohepatitis (MASH, formerly known as nonalcoholic steatohepatitis, or NASH) with cirrhosis, the most advanced form of MASH-related fibrosis. The Company's additional development programs are in the treatment of combination immunotherapy for advanced head and neck cancers and other malignancies.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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See More
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See More
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- Strategic Partnership Opportunities: Galectin is actively exploring strategic and financial partnerships to support the continued development and commercialization of belapectin, reflecting the company's confidence in future growth and focus on patient needs.
See More
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- Cash Dividend Plan: Prior to the merger's completion, Boundless Bio plans to declare a cash dividend to existing shareholders, aimed at boosting shareholder confidence and laying a solid foundation for the upcoming merger, which is expected to attract more investor interest.
- Clinical Candidate Development: Serapha's lead clinical candidate, SERP-01, is being developed for severe Alpha-1 Antitrypsin Deficiency, which is anticipated to provide new revenue streams for the company and strengthen its market position in the therapeutic area.
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See More
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- Trial Design: The trial will evaluate a single 2 mg dose of belapectin, aiming to prevent esophageal varices, using the same centralized, blinded endoscopy review process as in a previous trial, with a similar expected size, and plans to submit the final protocol to the FDA in Q3 2026.
- Market Sentiment Shift: Over the past 24 hours, retail sentiment around GALT shifted from 'bearish' to 'bullish', with message volume rising from 'normal' to 'high', indicating investor optimism regarding an upcoming partnership announcement and the market potential of belapectin.
- Strategic Partnership Exploration: CEO Joel Lewis noted that the agreement provides “important clarity” and renewed confidence, as Galectin actively seeks strategic partnerships to support the development of belapectin, although approval will follow the traditional full-approval pathway.
See More
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- FDA Meeting Outcome: Galectin Therapeutics achieved alignment with the U.S. FDA during a recent in-person Type C meeting, clarifying the primary endpoint and regulatory path for Belapectin in Metabolic Dysfunction-Associated Steatohepatitis (MASH) cirrhosis and portal hypertension, marking a significant advancement in the company's clinical development.
- Phase 3 Trial Plans: The company intends to submit the Phase 3 protocol in Q3 2026, conducting a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Belapectin in preventing disease progression in patients with MASH cirrhosis and portal hypertension, indicating potential benefits for patients.
- Clinical Endpoint Alignment: The FDA and Galectin agreed on a composite clinical endpoint that includes prevention of disease progression and the development of large esophageal varices greater than 5 mm, which is a meaningful indicator of worsening portal hypertension and MASH cirrhosis.
- Dose Evaluation Plan: Based on efficacy observed in prior clinical studies, the company plans to evaluate a single 2mg dose of Belapectin in the Phase 3 trial, aiming to advance clinical progress and attract strategic and financial partnership opportunities.
See More
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- Trial Design Confirmation: The FDA has agreed to key components of the Phase 3 program, including its design and primary endpoint, paving the way for potential full approval of belapectin, despite the previous Phase 2b/3 trial failing to meet its primary endpoint.
- Negative Market Reaction: Despite the agreement, Galectin's shares fell approximately 9% in premarket trading, reflecting market concerns regarding the company's future clinical trial outcomes, which could impact investor confidence.
- Future Plans: The company expects the planned study to be comparable in size to the NAVIGATE trial, targeting similar patient types, with the final Phase 3 protocol submission anticipated in Q3 2026, demonstrating the company's ongoing commitment to future research.
See More
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- Phase 3 Trial Plans: The company intends to submit the Phase 3 protocol in Q3 2026 to assess the safety and efficacy of belapectin in preventing disease progression in MASH cirrhosis patients, demonstrating a commitment to addressing substantial unmet medical needs.
- Clinical Assessment Methodology: The FDA accepted the company's proposed blinded central endoscopy review process, ensuring standardized and consistent assessment of esophageal varices across global studies, thereby enhancing the scientific rigor of the clinical trial.
- Strategic Partnership Opportunities: Galectin is actively exploring strategic and financial partnerships to support the continued development and commercialization of belapectin, reflecting the company's confidence in future growth and focus on patient needs.
See More
