Galmed Pharmaceu Stock Price, News & Analysis

Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced that the FDA approved its use of Aramchol meglumine in the Phase 3 ARMOR study, negating the need for additional clinical studies aside from minor pharmacology tests. Aramchol meglumine offers better water solubility and has patent protection until December 2034. This transition enables a once-daily dosing regimen that may enhance patient adherence. The company's CEO reported that the new formulation could cut the active pharmaceutical ingredient dosage by 50%, reducing costs significantly upon FDA approval.

Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced a conference call on August 5, 2021, at 8:30 AM ET, to discuss its clinical programs and Q2 2021 financial results. The company is focused on Aramchol, a drug in Phase 3 trials for nonalcoholic steatohepatitis (NASH) and fibrosis, which has received FDA Fast Track designation. NASH affects 3% to 5% of the U.S. population, making the success of Aramchol potentially significant for addressing this health crisis.

Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) reported financial results for Q1 2021 with a net loss of $8.9 million, or $0.38 per share, compared to $6.1 million, or $0.29 per share, in Q1 2020. The company achieved cash reserves of $58.9 million, up from $50.9 million at the end of 2020. Recent developments include IND approval from NMPA for the ARMOR Phase 3 study of Aramchol in China, and upcoming clinical data expected in Q4 2021. R&D expenses rose to $7.4 million, driven by increased drug development costs.

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.