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.
Rhea-AI Summary
Galmed Pharmaceuticals files its Annual Report on Form 20-F for the fiscal year 2023, focusing on the development of Aramchol for liver and fibro-inflammatory diseases.
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Galmed Pharmaceuticals (GLMD) secures a European patent for Aramchol and Resmetirom combination therapy for NASH/MASH and liver fibrosis, extending patent protection until 2039. The company aims to address multiple liver pathologies with a unique mechanism of action.
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Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced a delay of at least 6 months in the initiation of its Primary Sclerosing Cholangitis (PSC) Ph 2a Study. The delay is due to unexpected events, resulting in a disruption of work, and a subsequent estimation of a 6-9 month delay. Galmed had planned to complete a Ph1 pharmacokinetic (PK) study to determine the bioavailability of its lead compound, Aramchol meglumine, for the treatment of PSC. The company is working with local and international partners to mitigate the delays and will continue to update as soon as practical.
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Galmed Pharmaceuticals announces allowance of Japanese patent for treatment of pulmonary and dermal fibrosis, strengthening patent protection for lead compound Aramchol until November 2037. Pre-clinical model shows significant anti-fibrotic effects of Aramchol. CEO highlights potential for Aramchol in treating various fibrotic indications.
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Galmed Pharmaceuticals received a letter from Nasdaq indicating non-compliance with minimum bid price requirement. The company has 180 days to regain compliance by maintaining a minimum bid price of $1 for 10 consecutive days. Failure to do so may result in delisting.
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Galmed Pharmaceuticals Ltd. has entered into securities purchase agreements with two institutional investors to purchase 5,600,000 of its ordinary shares and warrants to purchase 5,600,000 ordinary shares at a combined purchase price of $1.25 per ordinary share and accompanying warrant, expected to raise approximately $7.0 million in gross proceeds.
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FAQ
What is the primary focus of Galmed Pharmaceuticals?
Galmed Pharmaceuticals focuses on developing and commercializing Aramchol, an oral therapy for liver diseases like NASH and PSC.
What are Galmed Pharmaceuticals' recent achievements?
Recent achievements include a strategic AI partnership with OnKai, raising $7 million through a securities purchase agreement, and obtaining a Japanese patent for Aramchol.
What is Aramchol?
Aramchol is a first-in-class synthetic fatty-acid/bile-acid conjugate (FABAC) developed as an oral therapy for liver diseases, including NASH and PSC.
What other products are in Galmed's pipeline?
Besides Aramchol, Galmed is developing Amilo-5MER, a 5-amino acid synthetic peptide for treating fibro-inflammatory diseases.
What financial measures has Galmed taken recently?
Galmed raised approximately $7 million through a securities purchase agreement to support its clinical trials and ongoing projects.
With whom does Galmed Pharmaceuticals collaborate?
Galmed collaborates with OnKai for AI-driven clinical trials and the Hebrew University for developing Amilo-5MER.
How is Galmed addressing compliance with Nasdaq listing requirements?
Galmed is working to maintain a minimum bid price of $1.00 per share and has 180 days to regain compliance with Nasdaq's requirements.
What is the significance of Galmed's recent patent approvals?
The Japanese patent extends protection for Aramchol until 2037, ensuring market exclusivity and enhancing its intellectual property portfolio.
Are there any delays in Galmed's clinical trials?
Yes, due to unforeseen events, the initiation of the Phase 2a PSC study has been delayed by 6-9 months.
What is the goal of the partnership with OnKai?
The partnership aims to use AI to improve the enrollment and execution of clinical trials, particularly focusing on underrepresented communities.
Galmed Pharmaceuticals Ltd.
Nasdaq:GLMD
GLMD Rankings
GLMD Stock Data
2.00M
6.36M
3.66%
3.04%
0.22%
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