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) announced that it will hold a conference call and webcast on March 18, 2021, to discuss its financial results for the year ended December 31, 2020, and updates on its clinical programs for Aramchol. Aramchol is currently in Phase 3 trials for treating nonalcoholic steatohepatitis (NASH) and fibrosis. The company emphasizes that NASH affects 3% to 5% of the U.S. population, marking it as a significant health crisis. Aramchol has received FDA Fast Track Designation for its potential treatment.
On February 16, 2021, Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced the pricing of an underwritten public offering of 2,197,803 ordinary shares, aiming for gross proceeds of approximately $10 million. The offering's close is anticipated by February 18, 2021. Cantor Fitzgerald & Co. is the sole book-running manager. Galmed plans to utilize the proceeds for the continued development of its product pipeline, including its lead compound, Aramchol™, which is in a Phase 3 study for NASH treatment. The offering is made pursuant to a previously filed shelf registration statement.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced a proposed underwritten public offering of its Ordinary Shares on February 16, 2021. The Offering will involve shares sold solely by Galmed, with a possible 30-day underwriter option for an additional 15%. This offering is made under a previously filed "shelf" registration with the SEC. Cantor Fitzgerald & Co. is the sole book-running manager. Investors are advised to review the preliminary prospectus for complete details about the Offering.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced the upcoming publication of a research paper on January 28, 2021, in JHEP Reports. The study reveals Aramchol's role in reducing SCD1 in hepatic stellate cells, contributing to fibrosis attenuation. This discovery supports Aramchol's potential as an antifibrotic agent in the ongoing Phase 3 ARMOR study for patients with NASH and fibrosis. Prof. Scott Friedman, a key researcher, emphasizes its dual mechanism: reducing liver fat and inhibiting fibrosis.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announces a Key Opinion Leader symposium on January 26, 2021, focusing on its pipeline assets, Aramchol and Amilo-5MER. Aramchol is in Phase 3 trials for non-alcoholic steatohepatitis (NASH) and liver fibrosis, while Amilo-5MER is under development for chronic inflammatory disorders. The event will feature experts Arun Sanyal, MD, and Shomron Ben-Horin, MD, who will provide insights into these therapies. A Q&A session is planned, and a replay will be available on Galmed's website afterward.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced an open-label addition to its ARMOR Phase 3 study for Aramchol, aiming to evaluate its efficacy in approximately 150 patients. This change allows all enrolled patients to transition to an active regimen of Aramchol 300mg, with initial data expected by Q4 2021. The company also revealed positive Phase 1 results for Aramchol meglumine, which shows similar pharmacokinetics to Aramchol acid. These developments may expedite FDA discussions for introducing Aramchol meglumine into the study, enhancing the chances of regulatory approval.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) reported its financial results for Q3 2020, revealing a net loss of $6.9 million, or $0.32 per share, up from a net loss of $4.5 million in Q3 2019. Cash reserves decreased to $58.7 million from $75.6 million at year-end 2019. R&D expenses rose to $6.5 million, primarily due to ongoing clinical trials for Aramchol™, its treatment for NASH. Galmed's drug has received Fast Track designation from the FDA, highlighting its potential in addressing the growing NASH epidemic, which affects 3% to 5% of the U.S. population.
Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) has entered a collaboration with MyBiotics Pharma Ltd. to enhance the clinical efficacy of its drug Aramchol for treating non-alcoholic steatohepatitis (NASH). Utilizing MyBiotics' SuperDonor technology and AI-driven platforms, the partnership aims to optimize gut microbiome profiles to improve patient response to Aramchol. This follows successful prior studies demonstrating Aramchol's potential in managing NASH-related liver pathologies. Additionally, MyBiotics plans to start Phase I trials for its CDI treatment candidate in 2021.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced a conference call on November 12, 2020, to discuss its financial results for Q3 2020 and provide updates on clinical programs for Aramchol, a treatment for nonalcoholic steatohepatitis (NASH). Aramchol is currently in a Phase 3 clinical trial and has received FDA Fast Track designation. NASH affects an estimated 3% to 5% of the U.S. population and is linked to obesity, leading to severe liver complications.
Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) and Gannex Pharma have entered into a research agreement to explore combination therapy using ASC41, a THR-beta agonist, and Aramchol, an SCD 1 inhibitor, for treating non-alcoholic steatohepatitis (NASH). ASC41 has recently received IND approval in China for clinical trials, with Phase I data expected by year-end. Aramchol, currently in Phase III trials, has shown significant efficacy in reducing liver fat and improving histology. NASH remains an unmet medical need with no approved treatments, emphasizing the collaboration's potential impact.