Welcome to our dedicated page for Galmed Pharmaceu news (Ticker: GLMD), a resource for investors and traders seeking the latest updates and insights on Galmed Pharmaceu stock.
Galmed Pharmaceuticals Ltd. develops Aramchol, an SCD1 inhibitor drug candidate, as a clinical-stage biopharmaceutical company focused on liver disease, cardiometabolic disease and gastrointestinal oncology therapeutics. Company updates frequently cover Aramchol development in NASH/MASH and fibrosis, combination approaches, patent activity, scientific presentations and efforts to expand the pipeline into oncology and cardiometabolic indications.
Recent developments also include collaborations and formulation work tied to Aramchol-based research, including human organoid models for cardiac fibrosis, preclinical evaluation in metastatic brain cancers and brain-penetrating delivery approaches for CNS-related applications. Other recurring corporate news includes annual-report filings, shareholder communications and Nasdaq listing compliance matters.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) reported its financial results for Q3 2020, revealing a net loss of $6.9 million, or $0.32 per share, up from a net loss of $4.5 million in Q3 2019. Cash reserves decreased to $58.7 million from $75.6 million at year-end 2019. R&D expenses rose to $6.5 million, primarily due to ongoing clinical trials for Aramchol™, its treatment for NASH. Galmed's drug has received Fast Track designation from the FDA, highlighting its potential in addressing the growing NASH epidemic, which affects 3% to 5% of the U.S. population.
Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) has entered a collaboration with MyBiotics Pharma Ltd. to enhance the clinical efficacy of its drug Aramchol for treating non-alcoholic steatohepatitis (NASH). Utilizing MyBiotics' SuperDonor technology and AI-driven platforms, the partnership aims to optimize gut microbiome profiles to improve patient response to Aramchol. This follows successful prior studies demonstrating Aramchol's potential in managing NASH-related liver pathologies. Additionally, MyBiotics plans to start Phase I trials for its CDI treatment candidate in 2021.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced a conference call on November 12, 2020, to discuss its financial results for Q3 2020 and provide updates on clinical programs for Aramchol, a treatment for nonalcoholic steatohepatitis (NASH). Aramchol is currently in a Phase 3 clinical trial and has received FDA Fast Track designation. NASH affects an estimated 3% to 5% of the U.S. population and is linked to obesity, leading to severe liver complications.
Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) and Gannex Pharma have entered into a research agreement to explore combination therapy using ASC41, a THR-beta agonist, and Aramchol, an SCD 1 inhibitor, for treating non-alcoholic steatohepatitis (NASH). ASC41 has recently received IND approval in China for clinical trials, with Phase I data expected by year-end. Aramchol, currently in Phase III trials, has shown significant efficacy in reducing liver fat and improving histology. NASH remains an unmet medical need with no approved treatments, emphasizing the collaboration's potential impact.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) provided updates on its clinical programs and reported financial results for Q2 2020. The Data Monitoring Committee approved the continuation of the ARMOR Phase 3 trial for NASH without protocol changes, with recruitment resuming earlier than expected. Cash reserves stood at $63.5 million, down from $75.6 million at year-end 2019. The net loss for Q2 was $5.5 million ($0.26 per share), up from $4.2 million the previous year. R&D expenses increased to $5.0 million, reflecting more costs for the manufacturing of Aramchol API. Galmed plans a Phase 1 study for Amilo-5MER.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced updates on its pipeline program, focusing on the development of Amilo-5MER, a synthetic peptide targeting chronic inflammatory diseases. The collaboration with the Hebrew University of Jerusalem highlights significant progress, supported by pre-clinical data indicating efficacy in reducing chronic inflammation. Amilo-5MER, which binds to pro-inflammatory proteins, shows potential for treating conditions like rheumatoid arthritis and COVID-19. The company plans to submit an IND in Q4 2020 and initiate Phase 1 studies, expecting to advance quickly in clinical development.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced a conference call on August 6, 2020, to discuss its financial results for the second quarter of 2020 and updates on its clinical programs for Aramchol, a treatment for nonalcoholic steatohepatitis (NASH) currently in Phase 3 trials. Aramchol has received Fast Track designation from the FDA and aims to address the rising NASH crisis affecting significant populations globally. The call will cover both financial metrics and clinical developments as the company progresses in its research efforts.