Welcome to our dedicated page for Galectin Therapeutics news (Ticker: GALT), a resource for investors and traders seeking the latest updates and insights on Galectin Therapeutics stock.
Galectin Therapeutics Inc. (NASDAQ: GALT) generates frequent news as a clinical-stage biopharmaceutical company developing galectin-targeted therapies for chronic liver disease and cancer. Most company updates focus on belapectin, its carbohydrate-based galectin-3 inhibitor, and the lead program in metabolic dysfunction-associated steatohepatitis (MASH) with cirrhosis and portal hypertension.
On this page, readers can follow news about clinical data from the NAVIGATE trial and related analyses, including outcomes on liver stiffness by FibroScan, Enhanced Liver Fibrosis (ELF) scores, and serum biomarkers such as PRO-C3, YKL-40, and PRO-C4. Galectin Therapeutics often reports how these measures relate to the incidence of new esophageal varices and portal hypertension risk categories in patients with compensated MASH cirrhosis.
News items also cover regulatory interactions with the U.S. Food and Drug Administration, such as Type C meeting requests, written feedback on trial design, and plans for potential pivotal Phase 3 development of belapectin. Investors can find announcements about Fast Track designation, presentation of NAVIGATE data at major liver disease meetings like AASLD and EASL, and participation in investor conferences and virtual key opinion leader events.
In addition, Galectin Therapeutics issues press releases on quarterly financial results, new or extended lines of credit and convertible notes, and corporate governance matters. These updates provide context on the company’s capital resources, development priorities, and timing of planned activities. For anyone tracking GALT, this news feed offers a centralized view of clinical milestones, regulatory developments, financing arrangements, and strategic communications related to belapectin and the company’s broader galectin-targeted pipeline.
Galectin Therapeutics (NASDAQ: GALT) has initiated the NASH-RX trial, targeting NASH cirrhosis patients at risk of esophageal varices. This international Phase 2b/3 trial assesses the efficacy of belapectin (GR-MD-02), previously shown to prevent varice development in earlier studies. With 315 patients expected across 130 sites, the trial features an adaptive design allowing seamless transitions between phases. An interim analysis will evaluate safety and efficacy after 78 weeks of treatment. Successful outcomes may enable accelerated FDA approval and partnerships, addressing a critical unmet need in liver disease.
Galectin Therapeutics has initiated patient enrollment for the NASH-RX trial, focusing on belapectin as a treatment for nonalcoholic steatohepatitis (NASH) cirrhosis. This adaptively-designed Phase 2b/3 trial targets patients at risk of developing esophageal varices, with a total enrollment of approximately 315 participants across 130 sites in 12 countries. Success in this trial could lead to accelerated FDA approval and partnership opportunities, addressing a significant unmet medical need in the treatment of NASH.
Galectin Therapeutics Inc. (NASDAQ: GALT) reported its Q1 2020 financial results, showing a net loss of $3.6 million ($0.06 per share), an improvement from $9.1 million ($0.20 per share) in Q1 2019. The company has filed a new protocol for its NASH-RX clinical trial with the FDA, aiming to begin patient enrollment in Q2 2020. The trial intends to assess the efficacy of belapectin for treating NASH cirrhosis. Additionally, a $100 million shelf registration statement has been filed with the SEC to facilitate future financing needs as ongoing costs for the clinical program are estimated at $125 million.
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