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.
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Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) has filed its Annual Report on Form 20-F for the fiscal year ending December 31, 2022, with the SEC. The report details their development of Aramchol for liver diseases and includes risks associated with clinical trials and regulatory approvals. Shareholders can access the report via the SEC and the company's Investor Relations website. Galmed remains focused on advancing Aramchol and collaborating on the development of other therapies, including Amilo-5MER.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced that the U.S. Patent and Trademark Office granted patent 11,571,431 B2, extending Aramchol's exclusivity to December 2034. This patent protects Aramchol's use, particularly in treating NASH and Fibrosis, and fortifies its existing patent portfolio, which now encompasses over 20 issued patents worldwide. The N-methylglucamine salt form, noted for its advantageous properties, enhances absorption and bioavailability. CEO Allen Baharaff emphasized that this patent strengthens their ability to maximize Aramchol's therapeutic potential across various indications.
Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) announced significant findings from the ARMOR study regarding their treatment Aramchol for NASH. The study revealed a 39% improvement in fibrosis and a 61% improvement based on ranked assessments. Key results included a highly statistically significant reduction in liver stiffness and liver injury markers (ALT and AST), all showing p-values . Galmed plans to submit this data to the FDA for consideration of advanced histology reading methodologies as primary endpoints in future NASH studies.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced on December 13, 2022, that it received an extension from Nasdaq to regain compliance with the minimum bid price requirement of $1 per share. This new compliance period extends until June 12, 2023, following an initial notification on June 17, 2022. The company must close at or above $1 for 10 consecutive trading days to achieve compliance. Galmed is focused on developing Aramchol and Amilo-5MER, targeting liver disease treatment.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) reported its financial results for the second quarter of 2022, revealing a net loss of $3.7 million ($0.15 per share), a decrease from $8.4 million ($0.33 per share) in Q2 2021. Cash and equivalents totaled $22.5 million by June 30, 2022, down from $34.9 million at the end of 2021. The company is discontinuing the Open Label Part of the ARMOR study to redirect efforts towards new anti-fibrotic indications and implementing a cost-reduction plan, including staff cuts. R&D expenses fell to $2.6 million from $7 million in 2021.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced significant clinical results for Aramchol, showing substantial anti-fibrotic effects in pre-clinical models of lung and gastrointestinal fibrosis. In lung fibrosis, Aramchol demonstrated improvements comparable to the standard treatment, Pirfenidone, with notable statistical significance (P0.001 to P<0.005). The drug also showed promising results in a model of inflammatory bowel disease (IBD), outperforming current gold standard treatments. The company aims to expand Aramchol's clinical development for additional indications.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced that it has received a notification from Nasdaq, stating that it is not in compliance with the minimum bid price requirement of $1.00 per share. The company has until December 12, 2022, to regain compliance by maintaining this price for ten consecutive business days. If compliance is not achieved, Galmed may face delisting. During this grace period, shares will continue to trade normally. The company is developing treatments for liver and metabolic diseases, including its lead compound, Aramchol™, currently in Phase 3 trials.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) reported its financial results for Q1 2022, highlighting a net loss of $6.1 million ($0.24 per share), an improvement from a loss of $8.9 million ($0.38 per share) in Q1 2021. Cash and equivalents decreased to $28.9 million from $34.9 million at year-end 2021. R&D expenses fell to $4.8 million from $7.4 million, while G&A expenses also decreased to $1.3 million from $1.8 million. The company is expanding its clinical strategy into new anti-fibrotic indications while discontinuing the Open Label Part of the Armor Study, having achieved its objectives.