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 (Nasdaq: GLMD) has published one-year results of the Open-Label part (ARCON) of its global Phase 3 trial of Aramchol in 150 patients with NASH and fibrosis (ARMOR) in Hepatology. The study demonstrated that Aramchol 300mg BID resulted in a high rate of subjects with histological fibrosis improvement. Aramchol, a down regulator of SCD-1, has shown potential as a potent anti-fibrotic compound for treating metabolic dysfunction associated steatohepatitis (MASH).
The study utilized three objective measurements: NASH CRN, paired ranked reading, and Artificial Intelligence (AI) quantitative digital analysis. The rigorous multimodality histology assessment, including FibroNest™ AI digital pathology, allowed researchers to identify regression changes and affirm the AI Digital Pathology analysis findings.
Galmed Pharmaceuticals (Nasdaq: GLMD) announced plans to expand its drug development activities beyond liver diseases to include cancer and major cardiometabolic diseases. This decision is based on recent results from the Open-Label part of its Phase 3 NASH study, new scientific publications on SCD1's role, and an extended cash runway. The company plans to:
1. Develop Aramchol-based drug combinations for advanced colorectal and hepatic cancers.
2. Create novel Aramchol-based combinations targeting cardiac fibrosis.
3. Release new data from in-vitro and ex-vivo studies in Q4 2024.
Galmed raised $7.5 million through warrant exercises and equity line drawdowns. The expansion leverages Aramchol, the most clinically advanced SCD1 oral inhibitor, which has shown an excellent safety profile with metabolic and anti-fibrotic effects in Phase 2 and 3 trials.
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