Galmed Pharmaceu Stock Price, News & Analysis

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.

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.