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, Inc. (NASDAQ: GALT) announced that its management will present at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The virtual conference will include a presentation starting at 7:00 A.M. (ET) on September 13, along with 1-on-1 meetings with investors. Galectin's lead drug, belapectin, targets galectin-3, which is linked to diseases such as NASH and fibrosis. The NAVIGATE trial for belapectin in preventing esophageal varices in NASH cirrhosis is ongoing. More details can be found on their official website.
Galectin Therapeutics (NASDAQ:GALT) announced key leadership appointments to strengthen its management team, including Dakshina Reddy as Executive Director of Regulatory Affairs and Ezra R. Lowe, Ph.D., as Executive Director of Clinical and Preclinical Pharmacology. These changes aim to enhance the company's efforts in cancer immunotherapy and NASH cirrhosis treatments. CEO Joel Lewis emphasized that these experienced hires will facilitate advancement in clinical trials, particularly for their lead drug, belapectin, which targets galectin-3 and is involved in pivotal studies like the NAVIGATE trial.
Galectin Therapeutics Inc. (NASDAQ: GALT) announced a net loss of $8.5 million for Q2 2021, an increase from $6.2 million in Q2 2020. The rise is attributed to increased R&D expenses primarily for the NAVIGATE trial in NASH cirrhosis, totaling $6.5 million this quarter. Despite these challenges, positive results in ongoing cancer immunotherapy trials enhance the rationale for a larger Phase 2 study. The company has $31.6 million in cash as of June 30, 2021, and anticipates needing an additional $30-$35 million by late 2023 to support ongoing trials.
Galectin Therapeutics Inc. (NASDAQ:GALT) announced promising results from its extension cohort of a Phase 1b clinical trial investigating Belapectin combined with KEYTRUDA® in patients with metastatic melanoma and head and neck cancer. The trial demonstrated a 56% cancer control rate in melanoma and 40% in head and neck cancer. Notably, no toxicities related to Belapectin were reported, and adverse effects were mild. Researchers expressed optimism over the data, suggesting a rationale for a larger Phase 2 randomized controlled study to further explore this combination therapy.
Galectin Therapeutics (NASDAQ: GALT) reported a net loss of $6.3 million for Q1 2021, increasing from $3.6 million in Q1 2020, primarily due to heightened R&D expenses of $4.9 million attributed to the NAVIGATE trial for NASH cirrhosis. The company raised $10 million in convertible debt financing and launched NAVIGATEnash.com to educate stakeholders on NASH. Recent peer-reviewed results showed promising outcomes in a cancer immunotherapy trial combining belapectin with pembrolizumab, underscoring the potential of its galectin-3 inhibitor in oncology.
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.
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