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) has reported financial results for the three and nine months ending September 30, 2021, alongside updates on its clinical programs. The ARMOR study demonstrated that 60% of patients showed significant histological improvement with Aramchol 300mg BID. Financially, the company posted a net loss of $7.7 million, or $0.31 per share, compared to $6.9 million, or $0.32 per share, year-over-year. Cash and equivalents decreased to $42.0 million from $50.9 million at the end of 2020. Upcoming presentations include data at the Liver Meeting and in Hepatology journal.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) released promising data from the ARMOR Phase 3 study, revealing that 60% of the first 20 patients showed at least one-stage improvement in liver fibrosis after 24 weeks. Statistically significant reductions were observed in liver fibrosis biomarkers including ALT, AST, Fib-4, and ProC-3 in approximately 50 patients. The findings support the potential of Aramchol for regulatory submission under Sub-part H, with excellent safety and tolerability noted. A conference call is scheduled to discuss these results further.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) has announced positive preliminary results from the ARMOR Phase 3 study for its drug Aramchol. Among the first 16 patients, 15 showed reduced fibrosis progression, with 50% experiencing improvement by at least one stage. Notably, 19% of patients had fibrosis reduced by two points. Safety and tolerability of Aramchol were confirmed, and findings will be presented at The Liver Meeting Digital Experience 2021. CEO Allen Baharaff expressed optimism based on the data's support for Aramchol's clinical benefits.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced one-year results from the Phase 2b ARREST Trial of Aramchol for NASH, published in Nature Medicine. The trial involved 247 patients randomized to receive Aramchol or placebo, showing significant reductions in liver fat, improved liver histology, and a favorable safety profile. Aramchol targets SCD1, enhancing fatty acid oxidation and reducing fibrosis. Following ARREST, the ongoing Phase 3 ARMOR study aims to evaluate Aramchol's efficacy at a higher dosage, strengthening its potential as a treatment for NASH and associated fibrosis.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) has announced the publication of its compound Amilo-5MER in The Journal of Autoimmunity. This five-amino-acid peptide shows promise in treating chronic inflammation and autoimmune diseases by binding to Serum Amyloid A (SAA) and inhibiting pro-inflammatory cytokine release. Amilo-5MER demonstrated selective anti-inflammatory action in various cell types. Galmed's CEO highlighted the compound's potential therapeutic benefits for SAA-related conditions. Amilo-5MER is currently advancing towards human studies, complementing Galmed’s existing pipeline focused on liver and metabolic diseases.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) has received approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to proceed with clinical studies using Aramchol meglumine, following a similar agreement from the FDA. This transition to a more soluble compound is a part of their optimization strategy for the Phase 3 ARMOR study. Aramchol, targeting nonalcoholic steatohepatitis (NASH), has been granted Fast Track Designation by the FDA, highlighting its potential in treating a serious condition affecting millions globally.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) reported its Q2 2021 financial results and updates on clinical programs. The company maintains $51.2 million in cash, consistent with the previous period. However, net losses increased to $8.4 million, or $0.33 per share, up from $5.5 million, or $0.26 per share, in Q2 2020. R&D expenses rose to approximately $7.0 million, driven by the ARMOR study. The FDA approved the use of Aramchol in the Phase 3 ARMOR study, with results expected in Q4 2021. Additionally, Galmed entered a license agreement for the development of Amilo-5Mer.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced that the FDA approved its use of Aramchol meglumine in the Phase 3 ARMOR study, negating the need for additional clinical studies aside from minor pharmacology tests. Aramchol meglumine offers better water solubility and has patent protection until December 2034. This transition enables a once-daily dosing regimen that may enhance patient adherence. The company's CEO reported that the new formulation could cut the active pharmaceutical ingredient dosage by 50%, reducing costs significantly upon FDA approval.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced a conference call on August 5, 2021, at 8:30 AM ET, to discuss its clinical programs and Q2 2021 financial results. The company is focused on Aramchol, a drug in Phase 3 trials for nonalcoholic steatohepatitis (NASH) and fibrosis, which has received FDA Fast Track designation. NASH affects 3% to 5% of the U.S. population, making the success of Aramchol potentially significant for addressing this health crisis.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) reported financial results for Q1 2021 with a net loss of $8.9 million, or $0.38 per share, compared to $6.1 million, or $0.29 per share, in Q1 2020. The company achieved cash reserves of $58.9 million, up from $50.9 million at the end of 2020. Recent developments include IND approval from NMPA for the ARMOR Phase 3 study of Aramchol in China, and upcoming clinical data expected in Q4 2021. R&D expenses rose to $7.4 million, driven by increased drug development costs.