Galmed Pharmaceu Stock Price, News & Analysis

Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) will host a conference call and webcast on May 13, 2021, at 8:30 AM ET, to discuss its clinical program updates and financial results for Q1 2021. The company is developing Aramchol, a treatment for nonalcoholic steatohepatitis (NASH) and fibrosis, currently in Phase 3 trials. NASH affects 3%-5% of the U.S. population and is a leading cause of liver-related health issues. Aramchol has received Fast Track designation from the FDA for its potential in treating this condition.

Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) has received approval from China's National Medical Products Administration (NMPA) for an Investigational New Drug (IND) application for its Phase 3 ARMOR study of Aramchol, aimed at treating NASH and fibrosis. The global study will occur at around 215 centers across multiple regions and evaluate Aramchol's safety and efficacy in subjects with NASH stages 2-3 who also suffer from obesity and diabetes. This milestone is significant, considering the rising prevalence of NASH in China, which is projected to increase from 15%-20% in 2018 to 25%-30% by 2033.

Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) reported a net loss of $10.3 million for Q4 2020 and $28.8 million for the full year, with EPS at $0.48 and $1.35, respectively. R&D expenses increased to $26.1 million in 2020 from $18.2 million in 2019 due to ongoing clinical trials for the ARMOR study of Aramchol™, targeting NASH and fibrosis. Cash and equivalents stood at $51.0 million at year-end. A Type C meeting with the FDA is planned for Q2 2021, and results from the ongoing study are expected in Q4 2021.

Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced the treatment of the first subject in a Phase I clinical trial for Amilo-5MER, targeting chronic inflammatory diseases like IBD and Rheumatoid Arthritis. The trial's primary goal is to assess the drug's safety, tolerability, and pharmacokinetics, enrolling up to 64 healthy subjects. Preliminary studies show that Amilo-5MER effectively reduces pro-inflammatory cytokine secretion, indicating potential as a treatment for autoimmune conditions and other serious illnesses linked to inflammation.

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.