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Galectin Therapeutics Inc. (NASDAQ: GALT) is a clinical-stage biopharmaceutical company that leverages its expertise in galectin science and drug development to create groundbreaking therapies for fibrotic diseases and cancer. The company’s flagship drug, belapectin (GR-MD-02), is a galectin-3 inhibitor that has shown promising results in reversing liver fibrosis and cirrhosis in preclinical models.
Galectin Therapeutics utilizes a unique carbohydrate technology to develop drug candidates that target galectin proteins, which are crucial in both biological and pathological processes. These carbohydrate-based compounds are designed to bind and inhibit galectin proteins, thereby providing therapeutic benefits in diseases where galectins play a pathogenic role. The company focuses on serious, life-threatening diseases with limited treatment options, aiming to bring new hope to patients and value to stakeholders.
The company’s lead development program is the NAVIGATE trial, a seamless, adaptive Phase 2b/3 study designed to evaluate belapectin for the prevention of esophageal varices in patients with nonalcoholic steatohepatitis (NASH) cirrhosis. This trial, which completed the randomization of 357 patients in February 2023, is expected to yield interim results in the fourth quarter of 2024. The study's innovative design allows for adaptive modifications, making it a pioneering effort in cirrhosis research.
Financially, Galectin Therapeutics reported a net loss of $9.2 million for the quarter ended June 30, 2023, compared to a net loss of $9.7 million for the same period in 2022. Research and development expenses decreased to $7.4 million, primarily due to the timing of costs related to the NAVIGATE trial. As of June 30, 2023, the company had $18.0 million in cash and cash equivalents, with an additional $30 million available under a $60 million line of credit provided by its chairman.
Additionally, the company is exploring the potential of belapectin in combination with Keytruda© for treating advanced head and neck cancers. Belapectin's unique mechanism of inhibiting galectin-3, a protein involved in multiple inflammatory, fibrotic, and malignant processes, makes it a versatile candidate for various indications.
Galectin Therapeutics continues to build its scientific and clinical team, recently adding key personnel in biostatistics, quality assurance, and clinical operations to manage its expanding portfolio and ongoing trials. The company's commitment to scientific excellence and clinical innovation positions it as a leader in the field of galectin-targeting therapies.
Galectin Therapeutics (NASDAQ: GALT) has completed enrollment for the NAVIGATE study, a Phase 2b/3 trial focused on belapectin for preventing esophageal varices in NASH cirrhosis. Conducted across 14 countries, the study randomized 309 patients, with final numbers projected between 325-340. Interim results are expected by Q4 2024. Belapectin targets galectin-3, crucial in NASH and fibrosis. This milestone enables the company to advance its program and explore other therapeutic opportunities for chronic liver disease and cancer.
Galectin Therapeutics (NASDAQ:GALT) announced a corporate update will be presented via live webcast after its 2022 Annual Meeting of Stockholders on December 1, 2022, starting at 11:00 a.m. ET. Shareholders can access the meeting at www.virtualshareholdermeeting.com/GALT2022. The company focuses on developing novel therapies for chronic liver disease and cancer, with its lead drug belapectin targeting NASH with advanced fibrosis, and has received Fast Track designation from the FDA.
NORCROSS, Ga., Nov. 28, 2022 (GLOBE NEWSWIRE) -- Galectin Therapeutics (NASDAQ: GALT) announced its participation in the 6th Obesity and NASH Drug Development Summit, where Dr. Pol F. Boudes will discuss drug development challenges for NASH cirrhosis on November 30, 2022. The company’s lead drug, Belapectin, targets galectin-3, playing a crucial role in NASH and fibrosis treatment. With promising preclinical outcomes and a Phase 2 trial underway, Galectin aims to prevent esophageal varices in NASH cirrhosis. NASH affects up to 28 million people in the U.S., highlighting the urgent need for effective therapies.
Galectin Therapeutics, Inc. (NASDAQ: GALT) announced its financial results for Q3 2022, reporting a net loss of $8.6 million, consistent with Q3 2021. The company secured its largest financing to date, extending its cash runway through 2024, while accelerating recruitment for its pivotal NASH cirrhosis trial, NAVIGATE, with 279 out of 315 patients randomized. Additionally, Galectin received FDA approval for its IND application for belapectin in combination with Keytruda for treating head and neck cancers.
Galectin Therapeutics (NASDAQ:GALT) announced five scientific presentations at The Liver Meeting™ 2022, focusing on liver cirrhosis and portal hypertension related to non-alcoholic steatohepatitis (NASH). Key topics include the prevalence of esophageal varices, the biochemical profiles of 271 NASH cirrhosis patients, and the clinical utility of the ELF score. The company aims to showcase new data on their drug candidate Belapectin, designed to inhibit the galectin-3 protein, which is involved in liver fibrosis. These findings contribute to ongoing Phase 2b/3 studies.
Galectin Therapeutics (NASDAQ: GALT) announced its participation in two upcoming conferences. On October 17, 2022, Dr. Pol F. Boudes will present at the H.C. Wainwright 6th Annual NASH Investor Conference. The second presentation will take place on October 20, 2022, at the Discovery on Target conference, focusing on belapectin, a galectin-3 inhibitor for NASH cirrhosis. Belapectin has shown promise in preclinical studies for reversing liver fibrosis. NASH affects millions in the U.S., and belapectin is under Fast Track designation for its potential treatment.
Galectin Therapeutics (NASDAQ: GALT) has filed an Investigational New Drug (IND) application with the FDA for belapectin in combination with pembrolizumab to treat head and neck cancer. The company received a 'Study May Proceed' letter for a Phase 2 trial focusing on recurrent/metastatic PD-L1 positive squamous cell carcinoma. This milestone adds to the ongoing NAVIGATE trial for NASH cirrhosis, which has seen an increase in active sites and steady enrollment progress. The potential partnership for financing the oncology program is also being explored.
Galectin Therapeutics (NASDAQ: GALT) announced positive results from its second independent Data and Safety Monitoring Board (DSMB) meeting regarding the NAVIGATE trial. This phase 2b/3 study evaluates belapectin for preventing esophageal varices in patients with NASH-related liver cirrhosis. The DSMB concluded belapectin showed a favorable safety profile, allowing the trial to proceed without changes. With 258 patients randomized and an additional 74 in screening, full enrollment is anticipated by year-end. This milestone reinforces the urgent need for new treatments for liver cirrhosis amidst rising NASH cases.
Galectin Therapeutics Inc. (NASDAQ: GALT) announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022. Dr. Pol F. Boudes, Chief Medical Officer, will present on September 13 at 11:00 AM ET. The company is focused on developing therapies targeting galectin proteins, particularly belapectin, for conditions like liver fibrosis and cirrhosis. Notably, belapectin shows promise in treating Non-alcoholic Steatohepatitis (NASH) and has Fast Track designation from the FDA. A live webcast of the presentation will be available on their website.
Galectin Therapeutics, Inc. (NASDAQ: GALT) reported financial results for Q2 2022, revealing a net loss of $9.7 million, or $0.16 per share, compared to a loss of $8.5 million, or $0.15 per share in Q2 2021. Major developments include securing a $60 million line of credit to fund the Phase 2b NAVIGATE trial and progress on an Investigational New Drug (IND) application for belapectin in treating recurrent head and neck cancer. The firm is on track to complete enrollment of the NAVIGATE trial by Q4 2022 and had $24.2 million in cash as of June 30, 2022.
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