Galmed Pharmaceu Stock Price, News & Analysis

Galmed Pharmaceuticals (NASDAQ: GLMD) reported its Q1 2025 financial results with several key developments. The company's net loss decreased to $1.1 million ($0.62 per share) compared to $1.3 million ($2.76 per share) in Q1 2024. Cash position strengthened to $20.1 million after raising $6.5 million since the start of 2025. Research and development expenses remained stable at $0.6 million, while general and administrative expenses decreased to $0.6 million from $0.8 million. Notable developments include promising results in oncology studies showing Aramchol enhancing Bayer's Regorafenib effect in GI cancer models, and signing a term sheet for developing a novel Semaglutide sublingual formulation. The company is actively diversifying its pipeline beyond liver disease into cardiometabolic and oncological indications.

Galmed Pharmaceuticals (NASDAQ: GLMD) announced significant results for Aramchol, their SCD1 inhibitor drug, in pre-clinical models of primary sclerosing cholangitis (PSC). The study showed Aramchol both prevented and reduced biliary fibrosis in PSC mouse models, with a 2-fold significant inhibition (p<0.05) of TGFβ-induced hepatic fibrosis pathways. The drug demonstrated dose-dependent reduction in fibrotic markers and hepatic stellate cell-activating genes in human and mouse cells. These findings are particularly significant as PSC carries a 20% lifetime risk of developing cholangiocarcinoma (CCA), the second-most prevalent liver malignancy. Building on previous successful clinical trials showing improvement in liver fibrosis, including the ARREST Phase IIb trial and ARMOR Phase III study, Galmed plans to advance Aramchol towards Phase 2/3 clinical studies focusing on GI oncology indications.

Galmed Pharmaceuticals (NASDAQ: GLMD) has announced breakthrough results from oncology studies conducted at Virginia Commonwealth University, showing that Aramchol significantly enhances the effectiveness of Bayer's Regorafenib in treating GI cancers. The combination therapy demonstrated significant reduction in hepatic tumor growth in mice models through increased autophagy and death receptor signaling. The company plans to initiate a Phase 1b study at VCU's Massey Cancer Center in Q4 2025, testing the combination in patients with advanced GI cancers. The research revealed that Aramchol, a potent SCD1 inhibitor, interacted effectively with multiple kinase inhibitors, with Regorafenib showing the strongest results. The combination works by enhancing autophagy through distinct mechanisms, potentially offering a cost-effective first-line treatment for HCC and other liver and colorectal cancers.

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.