Welcome to our dedicated page for Galmed Pharmaceuticals Ltd. news (Ticker: GLMD), a resource for investors and traders seeking the latest updates and insights on Galmed Pharmaceuticals Ltd. stock.
Galmed Pharmaceuticals Ltd. (GLMD) is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative treatments for liver diseases and fibrotic conditions. Established in Israel on July 31, 2013, but with operations dating back to 2000, Galmed focuses on the development of Aramchol, a proprietary first-in-class synthetic fatty-acid/bile-acid conjugate (FABAC). Aramchol is a once-daily, oral therapy designed to address serious liver disorders such as Non-Alcoholic Steato-Hepatitis (NASH) and Primary Sclerosing Cholangitis (PSC).
Recent Achievements and Projects
- Galmed recently announced a strategic partnership with OnKai to utilize artificial intelligence (AI) for improving clinical trial enrollment and execution, particularly focusing on PSC.
- The company completed a securities purchase agreement with institutional investors, raising approximately $7 million, which will bolster its ongoing and future clinical trials.
- A granted Japanese patent extends Aramchol’s protection until November 2037, enhancing its IP portfolio and potential market exclusivity.
Financial Condition
- Galmed is listed on the Nasdaq Capital Market under the symbol GLMD and is actively pursuing compliance with Nasdaq's listing requirements, including maintaining a minimum bid price of $1.00 per share.
- The company’s recent fundraising efforts and careful financial management are geared towards advancing its clinical programs and ensuring sustainable growth.
Partnerships and Collaborations
- Galmed collaborates with various academic institutions, including the Hebrew University, to develop additional therapeutic candidates like Amilo-5MER, a 5-amino acid synthetic peptide.
Products and Pipeline
- Aramchol: Primarily developed for treating NASH and PSC, Aramchol has shown promising anti-fibrotic effects in pre-clinical and clinical studies.
- Amilo-5MER: Currently under development for potential applications in treating other fibro-inflammatory conditions.
In summary, Galmed Pharmaceuticals is at the forefront of developing transformative therapies for liver and fibrotic diseases. With its robust pipeline, strategic partnerships, and strong financial strategies, the company is well-positioned to make significant advancements in the biopharmaceutical field.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) has received approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to proceed with clinical studies using Aramchol meglumine, following a similar agreement from the FDA. This transition to a more soluble compound is a part of their optimization strategy for the Phase 3 ARMOR study. Aramchol, targeting nonalcoholic steatohepatitis (NASH), has been granted Fast Track Designation by the FDA, highlighting its potential in treating a serious condition affecting millions globally.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) reported its Q2 2021 financial results and updates on clinical programs. The company maintains $51.2 million in cash, consistent with the previous period. However, net losses increased to $8.4 million, or $0.33 per share, up from $5.5 million, or $0.26 per share, in Q2 2020. R&D expenses rose to approximately $7.0 million, driven by the ARMOR study. The FDA approved the use of Aramchol in the Phase 3 ARMOR study, with results expected in Q4 2021. Additionally, Galmed entered a license agreement for the development of Amilo-5Mer.
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.
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