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.
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.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced an open-label addition to its ARMOR Phase 3 study for Aramchol, aiming to evaluate its efficacy in approximately 150 patients. This change allows all enrolled patients to transition to an active regimen of Aramchol 300mg, with initial data expected by Q4 2021. The company also revealed positive Phase 1 results for Aramchol meglumine, which shows similar pharmacokinetics to Aramchol acid. These developments may expedite FDA discussions for introducing Aramchol meglumine into the study, enhancing the chances of regulatory approval.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) reported its financial results for Q3 2020, revealing a net loss of $6.9 million, or $0.32 per share, up from a net loss of $4.5 million in Q3 2019. Cash reserves decreased to $58.7 million from $75.6 million at year-end 2019. R&D expenses rose to $6.5 million, primarily due to ongoing clinical trials for Aramchol™, its treatment for NASH. Galmed's drug has received Fast Track designation from the FDA, highlighting its potential in addressing the growing NASH epidemic, which affects 3% to 5% of the U.S. population.
Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) has entered a collaboration with MyBiotics Pharma Ltd. to enhance the clinical efficacy of its drug Aramchol for treating non-alcoholic steatohepatitis (NASH). Utilizing MyBiotics' SuperDonor technology and AI-driven platforms, the partnership aims to optimize gut microbiome profiles to improve patient response to Aramchol. This follows successful prior studies demonstrating Aramchol's potential in managing NASH-related liver pathologies. Additionally, MyBiotics plans to start Phase I trials for its CDI treatment candidate in 2021.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced a conference call on November 12, 2020, to discuss its financial results for Q3 2020 and provide updates on clinical programs for Aramchol, a treatment for nonalcoholic steatohepatitis (NASH). Aramchol is currently in a Phase 3 clinical trial and has received FDA Fast Track designation. NASH affects an estimated 3% to 5% of the U.S. population and is linked to obesity, leading to severe liver complications.
Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) and Gannex Pharma have entered into a research agreement to explore combination therapy using ASC41, a THR-beta agonist, and Aramchol, an SCD 1 inhibitor, for treating non-alcoholic steatohepatitis (NASH). ASC41 has recently received IND approval in China for clinical trials, with Phase I data expected by year-end. Aramchol, currently in Phase III trials, has shown significant efficacy in reducing liver fat and improving histology. NASH remains an unmet medical need with no approved treatments, emphasizing the collaboration's potential impact.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) provided updates on its clinical programs and reported financial results for Q2 2020. The Data Monitoring Committee approved the continuation of the ARMOR Phase 3 trial for NASH without protocol changes, with recruitment resuming earlier than expected. Cash reserves stood at $63.5 million, down from $75.6 million at year-end 2019. The net loss for Q2 was $5.5 million ($0.26 per share), up from $4.2 million the previous year. R&D expenses increased to $5.0 million, reflecting more costs for the manufacturing of Aramchol API. Galmed plans a Phase 1 study for Amilo-5MER.
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