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) 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 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.
Galectin Therapeutics (NASDAQ: GALT) initiated its Phase 2b/3 NASH-RX trial targeting NASH cirrhosis, aiming to address a critical medical need. CEO Joel Lewis highlighted the trial's unique position as one of the few late-stage studies in this field. The first patient was enrolled in August 2020, with plans for global patient inclusion. Key appointments to the board, including Richard Zordani and Dr. Elissa Schwartz, aim to enhance financial and clinical expertise. The company also continues its commitment to the development of belapectin, a galectin-3 inhibitor, with potential applications beyond NASH cirrhosis.
Galectin Therapeutics (NASDAQ:GALT) announced an investor conference call to discuss its NASH-RX clinical trial and introduce new CEO Joel Lewis. The event is set for September 29, 2020, at 4:00 p.m. EDT, accessible via a dedicated phone line or webcast. The company aims to develop therapies for chronic liver disease and cancer, with its lead drug belapectin showing promise in treating NASH with cirrhosis. The press release also included forward-looking statements regarding the potential success of ongoing clinical programs and the challenges ahead.
Galectin Therapeutics (NASDAQ:GALT) announced its participation in the H.C. Wainwright 22nd Annual Virtual Global Investment Conference on September 14, 2020. Management will present at 12:30 p.m. EDT and provide a live webcast accessible via the conference website or the company's own site. Additionally, one-on-one meetings with investors will be available throughout the conference, which runs from September 14 - 16, 2020. Galectin focuses on developing therapies for chronic liver disease and cancer, with its lead drug belapectin targeting galectin-3.
Galectin Therapeutics (NASDAQ: GALT) announces the retirement of Dr. Harold Shlevin as CEO, transitioning to a consultant role while remaining on the Board. Joel Lewis, a veteran of over 22 years in executive management, has been appointed as the new CEO and President. The company bolstered its Board's expertise with the additions of Dr. Elissa Schwartz and Mr. Richard Zordani. The leadership change aims to enhance corporate strategy and oversee the global NASH-RX clinical trial using the galectin-3 inhibitor, belapectin (GR-MD-02), a drug targeting fatty liver disease.
Galectin Therapeutics (NASDAQ: GALT) reported its Q2 2020 financial results with a net loss of $6.2 million, or ($0.11) per share, up from $3.1 million, or ($0.06) per share, in Q2 2019. The increase was primarily due to $4.7 million in research and development expenses for the NASH-RX trial. The company is optimistic about the trial's potential for accelerated FDA approval and plans to enroll 315 patients across 130 sites globally. As of June 30, 2020, cash and equivalents totaled $40.8 million, with a $10 million line of credit available, sufficient to fund operations through September 2021.
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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