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 (NASDAQ: GLMD), a clinical-stage biopharmaceutical company specializing in liver, cardiometabolic diseases and GI oncological indications, has announced the filing of its Annual Report on Form 20-F for the fiscal year ended December 31, 2024, with the U.S. Securities and Exchange Commission.
The report is accessible on both the SEC website and Galmed's Investor Relations platform. Shareholders can request free copies of the annual report through the company's Investor Relations Department.
Galmed Pharmaceuticals (Nasdaq: GLMD) has published one-year results of the Open-Label part (ARCON) of its global Phase 3 trial of Aramchol in 150 patients with NASH and fibrosis (ARMOR) in Hepatology. The study demonstrated that Aramchol 300mg BID resulted in a high rate of subjects with histological fibrosis improvement. Aramchol, a down regulator of SCD-1, has shown potential as a potent anti-fibrotic compound for treating metabolic dysfunction associated steatohepatitis (MASH).
The study utilized three objective measurements: NASH CRN, paired ranked reading, and Artificial Intelligence (AI) quantitative digital analysis. The rigorous multimodality histology assessment, including FibroNest™ AI digital pathology, allowed researchers to identify regression changes and affirm the AI Digital Pathology analysis findings.
Galmed Pharmaceuticals (Nasdaq: GLMD) announced plans to expand its drug development activities beyond liver diseases to include cancer and major cardiometabolic diseases. This decision is based on recent results from the Open-Label part of its Phase 3 NASH study, new scientific publications on SCD1's role, and an extended cash runway. The company plans to:
1. Develop Aramchol-based drug combinations for advanced colorectal and hepatic cancers.
2. Create novel Aramchol-based combinations targeting cardiac fibrosis.
3. Release new data from in-vitro and ex-vivo studies in Q4 2024.
Galmed raised $7.5 million through warrant exercises and equity line drawdowns. The expansion leverages Aramchol, the most clinically advanced SCD1 oral inhibitor, which has shown an excellent safety profile with metabolic and anti-fibrotic effects in Phase 2 and 3 trials.
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