Galmed Pharmaceu Stock Price, News & Analysis

Galmed Pharmaceuticals (NASDAQ: GLMD) has signed a binding term-sheet with Entomus for licensing a novel sublingual formulation of semaglutide using Self-Emulsifying Drug Delivery System (SEDDS) technology. The formulation aims to provide an alternative to injectable (Ozempic/Wegovy) and oral (Rybelsus) semaglutide through sublingual administration.

The agreement, to be finalized within 90 days, will determine milestone and royalty payments. The development targets markets where semaglutide patents expire as early as 2026, including India, Brazil, GCC countries, and others, with potential for 505(b)2 approval pathway.

The sublingual delivery system is expected to enhance bioavailability compared to Rybelsus, reduce daily dosage, and potentially offer fewer side effects with more precise blood sugar control. The global GLP-1 market is projected to reach $120B+ in obesity and type 2 diabetes by 2030, with ex-US peak sales of ~$20B in 2032.

Galmed Pharmaceuticals (GLMD) has announced a research collaboration with Virginia Commonwealth University (VCU) to study Aramchol's potential in combating drug resistance in gastrointestinal cancers. The partnership will evaluate Aramchol, a first-in-class SCD1 inhibitor, in combination with standard therapies for advanced colorectal and liver cancers.

The collaboration builds on recent findings published in Nature Communications linking lipid metabolism to cancer drug resistance. The research focuses particularly on hepatocellular carcinoma (HCC), where approximately 75% of patients are refractory to or intolerant to current first-line monoclonal antibody treatments.

This initiative marks Galmed's strategic expansion from liver diseases into oncology. The company aims to develop a cost-effective alternative to existing treatments, with Aramchol's patent protection extending through 2035. VCU will conduct studies and analyze outcomes, while Galmed provides funding and materials.

Galmed Pharmaceuticals (Nasdaq: GLMD) has announced groundbreaking findings regarding pharmacodynamic blood markers for Aramchol, their leading SCD1 inhibitor. The analysis of blood samples from the Phase 3 ARMOR MASH study revealed a panel of 70 proteins that form a distinctive pharmacodynamic signature after 12 weeks of treatment.

The study, conducted in collaboration with Proteas Health, demonstrated that Aramchol treatment led to:

• Decreased markers of chronic systemic inflammation
• Reduced oxidative and cardiac stress
• Lower atherosclerotic plaque pathogenesis
• Significant reduction in ANP (Atrial Natriuretic Peptide)
• Stimulated expression of KDM4C, a protein that represses liver fibrosis

The companies are developing a cost-efficient, high-throughput assay to measure Aramchol's pharmacodynamic signature, which could streamline future clinical trials and enable real-time evaluation of drug response.

Galmed Pharmaceuticals (NASDAQ: GLMD) has announced positive preliminary results from Part 1 of the Ph1 Bioavailability AM-001 Study for Aramchol Meglumine, an enhanced formulation of their lead compound.

Key findings show that 400 mg of Aramchol Meglumine suspension achieved nearly double the area under the curve (AUC) compared to Aramchol acid tablets. The study suggests that a 200 mg once-daily oral dose will be optimal for future trials, improving patient compliance and potentially reducing manufacturing costs.

Aramchol Meglumine, granted NCE patent protection until 2035, demonstrates enhanced solubility, absorption, and systemic exposure compared to Aramchol acid. The FDA has approved the transition from Aramchol acid to Aramchol Meglumine under a new IND, with Part 2 of the study expected to conclude in H2 2025.

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.