Galectin Therapeutics GALT shares surged 11.4% on Tuesday after the company announced it had reached alignment with the FDA on key elements of the late-stage development program for belapectin, a galectin-3 inhibitor and its only clinical-stage drug candidate.
Belapectin is being developed for patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension, a population with limited treatment options and a high risk of progressing to life-threatening liver complications. The FDA feedback provides greater clarity on the clinical and regulatory pathway toward potential approval, representing a significant milestone for Galectin.
The positive update followed an in-person Type C meeting with the FDA, during which GALT secured agreement on the planned phase III study design, primary endpoint, central review methodology and overall regulatory framework for belapectin. The agency also acknowledged the substantial unmet medical need among patients with compensated MASH cirrhosis and portal hypertension.
Galectin now plans to submit the final phase III study protocol in the third quarter of 2026 while simultaneously exploring strategic and financial partnership opportunities to support the candidate’s development and commercialization.
FDA Alignment Shapes GALT's Phase III MASH Cirrhosis Study
Galectin’s planned phase III study is designed to evaluate belapectin for preventing disease progression in patients with MASH cirrhosis and portal hypertension. FDA alignment was reached on using a composite liver outcome as the primary endpoint, including the prevention of large esophageal varices greater than 5 mm, a clinically meaningful marker of worsening portal hypertension and disease progression in patients with compensated MASH cirrhosis. GALT plans to include the development of large esophageal varices as one component of composite clinical outcome endpoints in the planned phase III study.
The FDA also accepted Galectin’s proposed blinded central review process for endoscopic assessment of esophageal varices. The methodology was developed and successfully implemented in the company’s global phase IIb/III NAVIGATE study and is intended to ensure standardized, objective and consistent assessment of endoscopic outcomes across study sites. The NAVIGATE study evaluated belapectin administered intravenously at 2 mg/kg or 4 mg/kg of lean body mass every two weeks for 18 months in patients with MASH cirrhosis.
GALT plans to evaluate only the 2 mg dose of belapectin in the impending phase III compensated MASH cirrhosis and portal hypertension study. That decision is based on efficacy signals observed in previous studies, particularly the NAVIGATE study.
Year to date, Galectin shares have lost 25% compared with the industry’s 7.9% decline.
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In the NAVIGATE study, the intent-to-treat population showed a 43.2% reduction in the incidence of esophageal varices at 18 months with the 2 mg/kg dose compared with placebo. However, the composite endpoint did not achieve statistical significance. Results were stronger in the per-protocol population, where belapectin reduced varices incidence by 49.3% compared with placebo. Among U.S. patients in the per-protocol group, the reduction reached 68.1%.
The study also demonstrated a favorable safety profile. Additional analyses showed improvements in non-invasive fibrosis and disease progression markers, supporting belapectin’s potential disease-modifying effects in compensated MASH cirrhosis with portal hypertension. Analysis of mechanistic biomarkers indicated that belapectin therapy was associated with reduced inflammation and fibrogenesis, while other analyses suggested improvements in portal hypertension risk categories and a lower risk of hepatic decompensation compared with placebo.
Given the similarities between the planned phase III population and that of the NAVIGATE study, including the focus on patients with MASH cirrhosis and portal hypertension, and the evaluation of a single belapectin dose, Galectin expects the upcoming late-stage study to be broadly comparable in size to the NAVIGATE study.
Regulatory Pathway Supports Potential Full Approval Opportunity
The FDA indicated that belapectin's development program will follow the traditional approval pathway required for patients with MASH cirrhosis, unlike earlier-stage MASH populations, where accelerated approval based on histological endpoints may be possible. The agency agreed that the proposed composite clinical outcome endpoints, including the development of large varices, and the overall study framework, are suitable for supporting a full approval application.
Galectin also noted the FDA’s recent guidance that the use of a single, adequate and well-controlled confirmatory study for marketing approval may support a streamlined development strategy. Based on the agency’s feedback, the company believes the planned phase III study establishes a clear path toward a broad indication focused on preventing disease progression in patients with MASH cirrhosis.
GALT’s Other Programs Depend on Future Partnership Opportunities
Beyond its liver disease program, Galectin is conducting mid-stage development of belapectin in oncology settings, including combination immunotherapy approaches for advanced head and neck cancers and other malignancies. However, progress in these programs is expected to depend largely on the company's ability to secure suitable development partners.
GALT continues to focus resources on advancing belapectin. Management is actively pursuing strategic and financial partnerships that could help fund both the upcoming phase III MASH cirrhosis study and future expansion into additional therapeutic indications.
Galectin Therapeutics Inc. Price and Consensus
Galectin Therapeutics Inc. price-consensus-chart | Galectin Therapeutics Inc. Quote
GALT’s Zacks Rank & Stocks to Consider
Galectin currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Liquidia Corporation LQDA, Indivior Pharmaceuticals INDV and Immunocore IMCR, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Liquidia Corporation’s 2026 EPS have increased from $1.50 to $2.97. Over the same period, EPS estimates for 2027 have also increased from $2.91 to $4.81. LQDA shares have rallied 118.9% year to date.
Liquidia Corporation’searnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.33 to $4.05. Over the same period, EPS estimates for 2027 have risen to $4.27 from $3.66. INDV shares have gained 6.8% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
The estimate for Immunocore’s 2026 EPS is currently pegged at 6 cents. In the past 60 days, the estimates for its 2027 EPS have increased from 24 cents to 87 cents. IMCR shares have lost 15.4% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
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