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) announced positive interim results from the ARMOR study, showcasing Aramchol's effectiveness in improving fibrosis in NASH patients. The net loss for 2021 was $32.5 million, with R&D expenses increasing to $27.2 million, driven by ongoing clinical trials. Despite a reduced net loss in Q4 2021 ($7.5 million) compared to Q4 2020, cash reserves fell to $34.9 million. The company indicates a strong focus on advancing Aramchol through its Phase 3 study while also exploring additional collaborations.
Galmed Pharmaceuticals (NASDAQ: GLMD) announced positive interim results from the ARMOR study's open-label phase, demonstrating significant fibrosis improvement with Aramchol 300mg BID in patients with NASH. At 48 weeks, the paired reading and AI analysis showed 65% and 100% of subjects had fibrosis improvement. The study utilized various histopathological methodologies to enhance assessment accuracy. CEO Allen Baharaff emphasized the study's relevance for future NASH clinical trials, reinforcing Galmed's commitment to advancing biopsy reading techniques.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced a conference call on May 2, 2022, to discuss its financial results for the fourth quarter and year ended December 31, 2021, along with updates on its clinical programs for Aramchol, a treatment for nonalcoholic steatohepatitis (NASH). Aramchol is currently in a Phase 3 clinical trial and has received Fast Track designation from the FDA. NASH affects an estimated 3% to 5% of the U.S. population and is a leading cause of liver complications.
Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) announced the granting of three new US patents for Aramchol, enhancing its intellectual property (IP) protection. These patents include the treatment of hepatic fibrosis and modulating gut microbiota, extending Aramchol's protection until December 2038. The Chief Executive Officer noted these patents strengthen their clinical development strategy following positive interim data from the ARMOR Phase 3 trial for NASH and fibrosis. The patents encompass low-dose compositions and potential new treatment modalities, reinforcing Galmed's market position.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced positive results from a Phase 1 clinical trial of Amilo-5MER, a synthetic peptide targeting liver and inflammatory diseases. Conducted on 64 healthy subjects, the trial demonstrated excellent safety and tolerability across all doses tested (10-360 mg). Amilo-5MER showed potential anti-inflammatory effects by binding to pro-inflammatory proteins, indicating a promising future for various therapeutic applications. The company aims to submit an IND for ulcerative colitis in 2022, further advancing its product pipeline.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) has reported financial results for the three and nine months ending September 30, 2021, alongside updates on its clinical programs. The ARMOR study demonstrated that 60% of patients showed significant histological improvement with Aramchol 300mg BID. Financially, the company posted a net loss of $7.7 million, or $0.31 per share, compared to $6.9 million, or $0.32 per share, year-over-year. Cash and equivalents decreased to $42.0 million from $50.9 million at the end of 2020. Upcoming presentations include data at the Liver Meeting and in Hepatology journal.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) released promising data from the ARMOR Phase 3 study, revealing that 60% of the first 20 patients showed at least one-stage improvement in liver fibrosis after 24 weeks. Statistically significant reductions were observed in liver fibrosis biomarkers including ALT, AST, Fib-4, and ProC-3 in approximately 50 patients. The findings support the potential of Aramchol for regulatory submission under Sub-part H, with excellent safety and tolerability noted. A conference call is scheduled to discuss these results further.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) has announced positive preliminary results from the ARMOR Phase 3 study for its drug Aramchol. Among the first 16 patients, 15 showed reduced fibrosis progression, with 50% experiencing improvement by at least one stage. Notably, 19% of patients had fibrosis reduced by two points. Safety and tolerability of Aramchol were confirmed, and findings will be presented at The Liver Meeting Digital Experience 2021. CEO Allen Baharaff expressed optimism based on the data's support for Aramchol's clinical benefits.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced one-year results from the Phase 2b ARREST Trial of Aramchol for NASH, published in Nature Medicine. The trial involved 247 patients randomized to receive Aramchol or placebo, showing significant reductions in liver fat, improved liver histology, and a favorable safety profile. Aramchol targets SCD1, enhancing fatty acid oxidation and reducing fibrosis. Following ARREST, the ongoing Phase 3 ARMOR study aims to evaluate Aramchol's efficacy at a higher dosage, strengthening its potential as a treatment for NASH and associated fibrosis.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) has announced the publication of its compound Amilo-5MER in The Journal of Autoimmunity. This five-amino-acid peptide shows promise in treating chronic inflammation and autoimmune diseases by binding to Serum Amyloid A (SAA) and inhibiting pro-inflammatory cytokine release. Amilo-5MER demonstrated selective anti-inflammatory action in various cell types. Galmed's CEO highlighted the compound's potential therapeutic benefits for SAA-related conditions. Amilo-5MER is currently advancing towards human studies, complementing Galmed’s existing pipeline focused on liver and metabolic diseases.
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