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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) announced that Pol F. Boudes, M.D., Chief Medical Officer, will present the belapectin program at the 4th Global NASH Congress on April 28-29, 2021. The presentation will focus on the clinical development of belapectin for NASH cirrhosis, aimed at preventing esophageal varices. Belapectin has shown promise in a phase 2 study for reducing portal hypertension. The ongoing phase 2b/3 study targets patients with portal hypertension due to NASH cirrhosis, measuring esophageal varices development at 18 months.
Galectin Therapeutics announced the engagement of Dr. Ben Carson as a special consultant to enhance the development of its galectin-3 inhibitor, belapectin, targeting NASH cirrhosis and cancer immunotherapy. Additionally, the company secured a $10 million convertible debt financing from Chairman Richard E. Uihlein, with an interest rate of 2% annually, and a conversion price set at $5.00 per share. This funding aims to support the ongoing NAVIGATE clinical trial and further research into belapectin's therapeutic potential.
Galectin Therapeutics (GALT) announced promising results from a Phase 1 study combining belapectin, a galectin-3 inhibitor, with pembrolizumab (KEYTRUDA®) for treating advanced melanoma and head and neck cancers. In this study, 50% of melanoma and 33% of HNSCC patients showed an objective response, outperforming pembrolizumab alone. The combination therapy exhibited fewer adverse events and improved tumor microenvironment conditions. A randomized Phase 2 trial is planned to further evaluate efficacy and safety, building on these positive findings.
Galectin Therapeutics is currently recruiting patients for the NAVIGATE study, a Phase 2b/3 clinical trial investigating belapectin for preventing esophageal varices in patients with NASH cirrhosis. As the only treatment option is liver transplant, this trial represents a significant opportunity for patients. The study aims to enroll around 315 participants across 130 sites worldwide. Belapectin has shown potential in earlier studies to prevent esophageal varices, a serious complication of cirrhosis.
Galectin Therapeutics Inc. (NASDAQ: GALT) reported a fiscal 2020 net loss of $23.6 million, or $0.41 per share, up from a loss of $20.2 million in 2019. The increase in losses was primarily due to higher research and development costs, particularly for the NAVIGATE clinical trial. The Company has $27.1 million in cash and expects additional funding needs of approximately $45-$50 million to advance the NAVIGATE trial through its upcoming interim analysis in late 2023. CEO Joel Lewis expressed optimism about ongoing studies and organizational improvements.
Galectin Therapeutics (NASDAQ:GALT) announced significant findings published in OncoImmunology regarding belapectin, a galectin-3 inhibitor. Research showed that belapectin combined with an anti-OX40 antibody effectively reduces tumor progression, enhancing survival in tumor-bearing mice. This validates ongoing clinical trials combining belapectin with pembrolizumab (Keytruda), indicating potential to improve cancer treatment. Additionally, belapectin is under investigation for treating NASH cirrhosis, highlighting its dual focus on oncology and liver diseases.
Galectin Therapeutics (NASDAQ:GALT) announced that Dr. Pol Boudes, M.D., the Chief Medical Officer, will present a corporate overview at the H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021. The presentation will be accessible on-demand from March 9 at 7:00 am (EST) and will be archived for 90 days. The company focuses on developing therapies for chronic liver disease and cancer, with its lead drug, belapectin, targeting galectin-3, significant in inflammatory and malignant diseases, and holds FDA Fast Track designation.
Galectin Therapeutics (NASDAQ:GALT) announced that Dr. Pol F. Boudes, Chief Medical Officer, will present on Belapectin, a galectin-3 inhibitor in Phase 2b/3 for treating NASH cirrhosis, at the 4th Annual Digital NASH Summit on December 17, 2020, at 09:00 AM EST.
Belapectin targets galectin-3, a protein linked to liver diseases. Preclinical studies indicate its potential to reverse liver fibrosis and cirrhosis, with encouraging results from the NASH-CX clinical trial.
Galectin Therapeutics (NASDAQ:GALT) announced a successful 2020 Annual Meeting, where management updates highlighted clinical trials for belapectin, targeting cirrhosis. The transition in management was seamless, according to Chairman Dick Uihlein. CEO Joel Lewis emphasized the importance of data from a pharmacokinetic study for future research. Chief Medical Officer Pol Boudes discussed a promising combination therapy trial with Keytruda. The company aims to address non-alcoholic steatohepatitis (NASH), a significant liver condition affecting millions.
Galectin Therapeutics Inc. (NASDAQ:GALT) will present a corporate update during its 2020 Annual Meeting of Stockholders on December 3, 2020, at 11:00 a.m. EST. This live webcast follows the business portion of the meeting and can be accessed online. The company focuses on developing therapies for chronic liver disease and cancer, with its lead drug, belapectin, targeting galectin-3 protein involved in various inflammatory and malignant diseases. Belapectin has received Fast Track designation for NASH cirrhosis by the FDA. Additional programs are underway in immunotherapy for advanced melanoma.
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