GALT

NORCROSS, Ga., May 15, 2026 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the three months ended March 31, 2026. “We continue to make meaningful progress advancing the belapectin program and further analyzing the NAVIGATE dataset in patients with MASH cirrhosis and portal hypertension. The additional analyses, including biomarker data, continue to support the potential of belapectin to impact disease progression in this high-risk population. We are looking forward to our upcoming data presentations at EASL later this month and our in-person Type-C meeting with FDA this quarter. Additionally, we remain focused on engaging with potential partners and leading experts to help determine the optimal path forward. This is an extremely exciting and consequential time in the Company’s history, and we will share updates as soon as possible.” said Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics. Belapectin Program Highlights Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of MASH and fibrosis. MASH Cirrhosis NAVIGATE Phase 2b/3 trial (NCT04365868) is a global, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of belapectin intravenously either belapectin 2 mg/kg of lean body mass (LBM) (n=119), 4 mg/kg/LBM (n=118) or placebo (n=118) every other week for 18 months for the prevention of esophageal varices in MASH cirrhosis. Additional analyses from the NAVIGATE trial, including biomarker data, continue to support the potential of belapectin to impact disease progression in this high-risk population. Statistically significant reductions in liver stiffness measurements (LSM), assessed by FibroScan®, were observed in the belapectin 2 mg/kg treatment arm at Weeks 26, 52 and 78, based on Mixed Model for Repeated Measures (MMRM) analyses of all clean and verified data collected throughout the study. Treatment with belapectin was associated with a reduction in the proportion of patients experiencing clinically meaningful worsening in liver stiffness compared to placebo, including fewer patients with >30% increases from baseline (11.7% vs. 23.9%; p=0.03) and fewer patients with combined increases of >10 kPa...

NORCROSS, Ga., May 11, 2026 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), a clinical-stage biotechnology company developing therapeutics that target galectin-3 for patients with MASH cirrhosis and portal hypertension, today 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. The manuscript, titled “Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in Patients with MASH Cirrhosis: The Randomized, Placebo-Controlled NAVIGATE Trial,” is now available online and available as an open-access publication. The NAVIGATE trial evaluated belapectin, a galectin-3 inhibitor, in patients with MASH cirrhosis and portal hypertension without esophageal varices at baseline. Results demonstrated that belapectin 2 mg/kg was associated with a numerical reduction in the development of new varices compared to placebo in the full analysis set, with a statistically significant reduction observed in the per-protocol population. Key markers of fibrosis including Liver Stiffness Measure results were aligned with the clinical finding belapectinwas generally safe and well tolerated. “These findings provide clinically meaningful evidence for the potential role of belapectin in addressing portal hypertension and reducing the risk of clinically significant complications in patients with MASH cirrhosis,” said Prof. Naga Chalasani, David W. Crabb Professor of Gastroenterology and Hepatology at Indiana University School of Medicine and principal investigator for the NAVIGATE program. “The observed reduction in variceal development, together with consistent biomarker findings and a favorable safety profile, supports continued development of belapectin in patients with MASH cirrhosis and portal hypertension—a population with substantial unmet medical need.” “These results further strengthen the clinical and mechanistic profile of belapectin in MASH cirrhosis and portal hypertension,” said Khurram Jamil, M.D., 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 b...

NORCROSS, Ga., March 31, 2026 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the year ended December 31, 2025. Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said “We are at an important juncture for the belapectin development program. During 2025, we made meaningful progress advancing the belapectin program and continuing our analysis of the NAVIGATE dataset in patients with MASH cirrhosis and portal hypertension. We are encouraged by the signals observed, including additional biomarkers from the NAVIGATE dataset, and remain focused on evaluating the data as we engage with regulators, potential partners, and leading experts to determine the optimal path forward for the program. Importantly, we also improved the Company’s financial position during the year, including securing an additional $10 million line of credit from our Chairman, Dick Uihlein, to extend our projected cash runway through April 2027. Also, just very recently, we have strengthened our Board with the appointment of Dr. Henry Brem, an internationally recognized neurosurgeon-scientist and leader in translational medicine, whose clinical development experience will be valuable as we advance the program. With no approved therapies currently available for patients with MASH cirrhosis, we believe belapectin has the potential to address a significant unmet medical need and look forward to discussing the program with FDA.” Khurram Jamil, M.D., Chief Medical Officer, added “The NAVIGATE dataset continues to provide encouraging insights supporting belapectin’s potential role in patients with MASH cirrhosis and portal hypertension. In addition to the previously reported clinical finding of reduced varices incidence in the per-protocol population, additional biomarker analyses have demonstrated consistent signals across specialized markers of fibrosis and noninvasive measures of liver stiffness, supporting belapectin’s potential antifibrotic activity and disease-modifying effect. These findings have been well received by the scientific community and were recently discussed by leading hepatology experts during our March 10, 2026 virtual KOL event, where the data were reviewed in the context of disease progression and portal...

NORCROSS, Ga., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the three and nine months ended September 30, 2025. “The new NAVIGATE data presented at AASLD further strengthen the clinical and mechanistic profile of belapectin. We continue to see encouraging consistency across key biomarkers—including FibroScan®, ELF, and PRO-C3—all supporting belapectin’s durable antifibrotic activity and potential to slow disease progression in patients with compensated MASH cirrhosis. We submitted the NAVIGATE data package to the FDA and requested feedback on proposed next steps, with guidance anticipated by year-end. As we move forward, our focus remains on advancing dialogue with FDA and exploring strategic opportunities to maximize the value of this promising program,” said Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics. Khurram Jamil, M.D., Chief Medical Officer, added, “Importantly, the concordant biomarker data across independent measures support the mechanistic rationale for Galectin-3 inhibition and highlight belapectin’s potential to favorably alter disease trajectory in patients with advanced, high-risk MASH cirrhosis. From a clinical and mechanistic standpoint, these biomarker analyses provide compelling evidence of belapectin’s biological activity and durability of effect. The data demonstrating reductions in Baveno VII defined portal hypertension risk categories are particularly encouraging, as they come from the sickest MASH cirrhosis patients studied to date. The results were consistent across both the overall and completer populations, with a clear dose-response observed, reinforcing the biological rationale. Taken together, these findings strengthen our confidence in belapectin’s mechanism of action and its potential to positively impact disease progression in this high-risk population.” Recent Highlights Earlier in November, at the 2025 AASLD Annual Meeting, Galectin presented new 18-month biomarker analyses from the NAVIGATE trial, further supporting the antifibrotic and disease-modifying potential of belapectin in patients with compensated MASH cirrhosis and portal hypertension. The updated results reinforce and extend previously reported findings. Belapectin d...

New biomarker analyses from the NAVIGATE trial demonstrated consistent antifibrotic effects of belapectin 2 mg/kg Using established criteria for clinically meaningful worsening, a lower proportion of patients treated with belapectin 2 mg/kg experienced ≥30% or ≥5 kPa increases in liver stiffness (LSM) by FibroScan® compared with placebo, indicating slowing of fibrosis progression and stabilization of liver function Across all ELF fibrosis risk categories, belapectin 2 mg/kg showed a lower incidence of new varices compared with placebo, with the largest benefit in patients with ELF > 11.3 (22.7% vs 42.9%), representing those at highest risk for liver complications Pro-C3 biomarker analysis demonstrated a >50% reduction from baseline at 18 months with belapectin 2 mg/kg versus placebo, supporting the therapy’s antifibrotic and disease-modifying potential in compensated MASH cirrhosis with portal hypertension. Analysis of YKL-40, a biomarker associated with Galectin-3 upregulation in fibrotic liver disease, demonstrated a ≥20% reduction in a higher proportion of patients treated with belapectin 2 mg/kg compared with placebo, providing additional mechanistic evidence of belapectin’s antifibrotic activity. Analysis of PRO-C4, a key biomarker of liver injury and fibrogenesis, showed a ≥20% increase in a higher proportion of placebo-treated patients compared with those receiving belapectin 2 mg/kg, consistent with ongoing fibrotic progression and further supporting belapectin’s disease-modifying potential For available patients who completed 36 months of therapy, belapectin maintained the sustained reduction in new variceal development seen at 18 months NORCROSS, Ga., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of galectin-3-targeted therapeutics for patients with MASH cirrhosis and portal hypertension, presented a poster and will deliver an oral presentation of the NAVIGATE study analysis at the AASLD 2025 Annual Meeting. The Phase 2 NAVIGATE trial evaluated belapectin, a proprietary galectin-3 inhibitor, in patients with compensated MASH cirrhosis and portal hypertension. The global Phase 2b NAVIGATE trial (NCT04365868) was a randomized, double-blind, placebo-controlled study evaluating the galectin-3 inhibitor belapectin in 355 patients with compensated MASH cirrhosis and portal hypertension confirmed by non-...

NORCROSS, Ga., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the three and six months ended June 30, 2025. Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, stated “We are encouraged by the continued analysis of data from our NAVIGATE trial , which further supports the clinical profile of belapectin in patients with MASH cirrhosis. At the European Association for the Study of the Liver (EASL) in May, we presented a clinically significant response in Fibroscan® (a key biomarker in MASH) and additional Fibroscan® data outcomes supporting the NAVIGATE trial’s primary endpoint, the prevention of esophageal varices after 18 months of treatment with belapectin. We believe it is especially promising that these findings remain robust in patients who received belapectin beyond 18 months, reinforcing our belief in the potential of belapectin to modify disease progression in this high-risk population. We are also analyzing additional biomarkers and expect to present those results later this year.” “In June, we hosted a webcast featuring two prominent key opinion leaders, Dr. Naga Chalasani and Dr. Naim Alkhouri, who provided valuable insight into the NAVIGATE data and evolving treatment landscape. Looking ahead, we remain focused on engaging with the U.S Food and Drug Administration later this year to discuss potential next steps for our program, while also continuing to explore strategic partnership opportunities. As stated previously, we continue to believe that belapectin has the potential to offer a much-needed new treatment option for the growing number of patients with MASH-associated liver cirrhosis and portal hypertension — a significant area of unmet medical need. Lastly, I again thank Mr. Richard E. Uihlein, our chairman, for his continued support through the additional $10 million debt financing announced in early July, which is expected to fund our current planned operations through second half of 2026.” Khurram Jamil, M.D., Chief Medical Officer, added, “The 18-month analysis showed a lower incidence of both liver stiffness progression and varices in the 2 mg belapectin arm compared to placebo — an encouraging signal, given that increasing liver stiffness is a well...

NORCROSS, Ga., May 15, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the three months ended March 31, 2025. Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, stated “This quarter, we remained laser-focused on advancing additional analyses for belapectin. I was extremely encouraged by the feedback we received last week at the European Association for the Study of the Liver (EASL), specifically that we successfully demonstrated a clinically significant response in a key biomarker (Fibroscan®) that is used to support outcomes in MASH trials at every stage of disease progression. In December 2024, as part of the topline results from the NAVIGATE trial, we reported that the 2 mg/kg dose of belapectin led to a significantly lower incidence of new varices compared to placebo in the per protocol population—validating the findings from our earlier Phase 2 study where 2 mg/kg dose showed significant reduction in portal pressure and new varices in cohort of patients without varices at baseline. Based on these results from the NAVIGATE trial presented at EASL, we continue to believe that belapectin has the potential to offer a much-needed new treatment option for the growing number of patients with MASH-associated liver cirrhosis and portal hypertension — a significant area of unmet medical need.” Khurram Jamil, M.D., Chief Medical Officer, added “We were pleased to present the analysis of the NAVIGATE trial coupled with biomarker analysis to the scientific community and industry stakeholders at EASL. We are particularly encouraged by the liver stiffness measure (LSM), which showed that approximately double the number of patients demonstrated worsening of liver stiffness on placebo compared to on belapectin. We also showed that the difference in new varices between the 2 mg/kg dose and placebo was primarily driven by a reduction in medium and large varices, rather than small ones. This is relevant for clinicians since it’s medium or large size varices that are more likely to bleed and or require additional treatment. We also demonstrated that the proportion of patients who experienced a significant worsening of LSM were significantly higher in the placebo group compared to the 2 mg/kg be...

Data presentation included efficacy and biomarker analyses from the NAVIGATE trial (n=287). Belapectin 2 mg/kg demonstrated a statistically significant reduction in new varices at 18 months in the per-protocol population (p=0.04). Significantly fewer patients in the belapectin treatment arms experienced worsening of liver stiffness as measured by FibroScan®, reinforcing the potential beneficial effect of belapectin in halting the progression of MASH cirrhosis. NORCROSS, Ga., May 12, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of galectin-3-targeted therapeutics for patients with MASH cirrhosis and portal hypertension, presented a late-breaking oral presentation of the NAVIGATE study analysis at the EASL 2025 Congress, on May 10, 2025, in Amsterdam, Netherlands. The NAVIGATE study evaluated belapectin, a galectin-3 inhibitor, in patients with MASH cirrhosis and portal hypertension. The NAVIGATE trial (NCT04365868) is a global, multicenter, randomized, double-blind, placebo-controlled study. A total of 355 patients were randomized in a 1:1:1 ratio to receive intravenous belapectin at either 2 mg/kg of lean body mass (LBM) (n=119), 4 mg/kg LBM (n=118), or placebo (n=118) every other week for 18 months. The primary endpoint was the prevention of varices, assessed as a composite clinical outcome that included patients who developed any varices, experienced intercurrent events, or lacked an endoscopy or intercurrent events at 18 months. The study evaluated both the intent-to-treat (ITT) population (N=355) and a pre-defined per-protocol population or completer population (PPP, N=287), the latter comprising patients who completed 18 months of treatment with upper endoscopies performed at both baseline and after 18 months of treatment. In the PPP population, the incidence of varices was 11.3% in the belapectin 2 mg/kg group and 13.5% in the 4 mg/kg group, compared to 22.3% in the placebo group. The 2 mg/kg dose demonstrated a 49.3% reduction in incidence of new varices compared to placebo (p=0.04), whereas the 4 mg/kg dose showed a 39.5% reduction in new varices compared to placebo (not statistically significant). These clinical findings were further supported by non-invasive assessments. Specifically, liver stiffness, measured via FibroScan®, showed a notably lower proportion of patients with worsening in liver stiffness....

NORCROSS, Ga., March 31, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the year ended December 31, 2024. Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said “In the U.S. approximately 5 million adults are affected by MASH cirrhosis and clinically significant portal hypertension. The need for new treatments that can prevent disease progression is more urgent than anticipated. The NAVIGATE trial’s per-protocol analysis in U.S. patients revealed a remarkable 68% reduction in the incidence of new varices, underscoring belapectin’s potential as a treatment for MASH cirrhosis and portal hypertension. The statistically significant results in per protocol population at 18 months are further reinforced by the favorable trend observed in available 36 month data. We look forward to sharing additional results, including specialized biomarkers analyses results, in the second quarter of 2025, and collaborating with potential partners and leading medical experts to define the optimal next steps in belapectin’s development. Finally, I want to thank Richard Uihlein, our chairman, for providing an additional $5 million line of credit this month that will allow us to extend our cash runway as we continue to analyze NAVIGATE results and prepare to discuss them with potential partners and the FDA.” Khurram Jamil, M.D., Chief Medical Officer added “I am encouraged by the 2 mg belapectin data, which demonstrated an approximately 49% reduction in varices incidence in the per-protocol population and a 68% reduction in the per-protocol population of U.S. patients, further validating the findings of our previous Phase 2b (GT-026) trial. Additionally, a total of 57 subjects completed 36 months of treatment and the positive trend that was observed at 18 months for the belapectin 2 mg cohort was sustained at 36 months, with a lower incidence of varices compared to placebo (13.0% vs. 20.0%). These results further support the potential of the 2 mg dose in preventing varices in MASH cirrhosis patients with portal hypertension. I believe the results warrant further clinical development as belapectin could become a pivotal therapeutic option for these patients who currently do not have any treatment options...