Galmed Pharmaceu Stock Price, News & Analysis

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.

Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) provided updates on its clinical programs and reported financial results for Q2 2020. The Data Monitoring Committee approved the continuation of the ARMOR Phase 3 trial for NASH without protocol changes, with recruitment resuming earlier than expected. Cash reserves stood at $63.5 million, down from $75.6 million at year-end 2019. The net loss for Q2 was $5.5 million ($0.26 per share), up from $4.2 million the previous year. R&D expenses increased to $5.0 million, reflecting more costs for the manufacturing of Aramchol API. Galmed plans a Phase 1 study for Amilo-5MER.

Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced updates on its pipeline program, focusing on the development of Amilo-5MER, a synthetic peptide targeting chronic inflammatory diseases. The collaboration with the Hebrew University of Jerusalem highlights significant progress, supported by pre-clinical data indicating efficacy in reducing chronic inflammation. Amilo-5MER, which binds to pro-inflammatory proteins, shows potential for treating conditions like rheumatoid arthritis and COVID-19. The company plans to submit an IND in Q4 2020 and initiate Phase 1 studies, expecting to advance quickly in clinical development.