Welcome to our dedicated page for Galmed Pharmaceu news (Ticker: GLMD), a resource for investors and traders seeking the latest updates and insights on Galmed Pharmaceu stock.
Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) is a clinical-stage biopharmaceutical company centered on the development of its lead candidate, Aramchol, for liver, cardiometabolic and gastrointestinal (GI) oncological indications. The GLMD news feed on Stock Titan aggregates company-issued updates, press releases and related coverage so readers can follow how Galmed’s Aramchol program and corporate strategy evolve over time.
News about Galmed frequently covers clinical and preclinical results for Aramchol. Recent announcements include meaningful top-line data from the AM-001 Phase 1 bioavailability study of Aramchol meglumine, as well as mechanism-of-action work in GI cancer models where combinations of Aramchol, Stivarga (regorafenib) and metformin significantly enhanced GI tumor cell killing in vivo and in vitro. Other items highlight Aramchol’s Phase 3-ready status in MASH/NASH and fibrosis and its positioning as an SCD1 down-regulator.
Investors can also use the GLMD news page to monitor intellectual property developments, such as new use patents covering Aramchol in combination with Rezdiffra (resmetirom) for MASH and liver fibrosis across multiple jurisdictions. Financial and corporate updates appear as well, including quarterly financial results, capital raises through at-the-market facilities, changes in authorized share capital, and Galmed’s adoption of a digital asset management strategy overseen by a Board-level Crypto Committee.
Because Galmed is pursuing Aramchol across liver disease, oncology and cardiometabolic areas, news items often provide insight into how the company prioritizes indications, structures collaborations with academic centers, and interprets biomarker findings from studies like ARMOR. Bookmark this page to review new GLMD press releases, SEC-linked announcements and scientific updates in one place.
Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) announced significant findings from the ARMOR study regarding their treatment Aramchol for NASH. The study revealed a 39% improvement in fibrosis and a 61% improvement based on ranked assessments. Key results included a highly statistically significant reduction in liver stiffness and liver injury markers (ALT and AST), all showing p-values <0.0001. Galmed plans to submit this data to the FDA for consideration of advanced histology reading methodologies as primary endpoints in future NASH studies.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced on December 13, 2022, that it received an extension from Nasdaq to regain compliance with the minimum bid price requirement of $1 per share. This new compliance period extends until June 12, 2023, following an initial notification on June 17, 2022. The company must close at or above $1 for 10 consecutive trading days to achieve compliance. Galmed is focused on developing Aramchol and Amilo-5MER, targeting liver disease treatment.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) reported its financial results for the second quarter of 2022, revealing a net loss of $3.7 million ($0.15 per share), a decrease from $8.4 million ($0.33 per share) in Q2 2021. Cash and equivalents totaled $22.5 million by June 30, 2022, down from $34.9 million at the end of 2021. The company is discontinuing the Open Label Part of the ARMOR study to redirect efforts towards new anti-fibrotic indications and implementing a cost-reduction plan, including staff cuts. R&D expenses fell to $2.6 million from $7 million in 2021.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced significant clinical results for Aramchol, showing substantial anti-fibrotic effects in pre-clinical models of lung and gastrointestinal fibrosis. In lung fibrosis, Aramchol demonstrated improvements comparable to the standard treatment, Pirfenidone, with notable statistical significance (P<0.001 to P<0.005). The drug also showed promising results in a model of inflammatory bowel disease (IBD), outperforming current gold standard treatments. The company aims to expand Aramchol's clinical development for additional indications.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced that it has received a notification from Nasdaq, stating that it is not in compliance with the minimum bid price requirement of $1.00 per share. The company has until December 12, 2022, to regain compliance by maintaining this price for ten consecutive business days. If compliance is not achieved, Galmed may face delisting. During this grace period, shares will continue to trade normally. The company is developing treatments for liver and metabolic diseases, including its lead compound, Aramchol™, currently in Phase 3 trials.
Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) reported its financial results for Q1 2022, highlighting a net loss of $6.1 million ($0.24 per share), an improvement from a loss of $8.9 million ($0.38 per share) in Q1 2021. Cash and equivalents decreased to $28.9 million from $34.9 million at year-end 2021. R&D expenses fell to $4.8 million from $7.4 million, while G&A expenses also decreased to $1.3 million from $1.8 million. The company is expanding its clinical strategy into new anti-fibrotic indications while discontinuing the Open Label Part of the Armor Study, having achieved its objectives.
Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) has announced a strategic shift in its clinical development plan to expand the use of its lead compound, Aramchol, into new anti-fibrotic indications. This follows positive outcomes from the Open-Label Part of the ARMOR study, demonstrating consistent anti-fibrotic effects at 48 weeks in NASH patients. The Open-Label study will be discontinued as its objectives are met. Cost reduction efforts will facilitate a faster transition to high unmet need areas. The company is also evaluating strategic alternatives to enhance shareholder value and plans to commence the registrational study in the latter half of 2023.
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.
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