Galmed Pharmaceuticals (Nasdaq: GLMD) enters into a Sponsored Project Agreement with Virginia Commonwealth University (VCU) to evaluate Aramchol's effect on overcoming drug resistance in gastrointestinal (GI) cancers. Aramchol, a first-in-class SCD1 inhibitor, will be studied in combination with standard therapies for advanced colorectal and liver cancers, aiming to reverse treatment resistance and improve outcomes in these high-mortality cancers. Collaboration builds on breakthrough findings published in ...

Analysis of blood samples from patients treated with Aramchol in ARMOR (Ph3 MASH Study) provides new and important insights into the biochemical and physiological effects of the drug. The pharmacodynamic signature associated with Aramchol treatment revealed a decrease in markers of chronic systemic inflammation, oxidative and cardiac stress, and atherosclerotic plaque pathogenesis. Data also show a significant decrease in ANP (Atrial Natriuretic Peptide), a clinically validated marker for heart failure. T ...

Core Insights - Galmed Pharmaceuticals has announced positive preliminary results from the AM-001 Study, marking a significant step in the development of Aramchol Meglumine, an improved formulation of its lead compound [1][7] - Aramchol Meglumine is a New Chemical Entity (NCE) with patent protection until 2035, being developed for various indications related to fatty acid metabolism [1][2] - The initial findings indicate that Aramchol Meglumine has higher bioavailability compared to Aramchol free acid, with a once-daily 200 mg dose likely to be optimal for future trials [1][5] Company Development - Galmed has successfully advanced Aramchol acid through six clinical trials, enrolling 661 subjects, establishing its safety and efficacy in treating NASH (MASH) [2] - The transition from Aramchol acid to Aramchol Meglumine was approved by the FDA, requiring only a bioavailability study for comparison [3][4] - The AM-001 study aims to identify optimal doses for advancing Aramchol Meglumine into Phase 2 studies, with Part 2 expected to conclude in the second half of 2025 [4] Clinical Findings - Preliminary results from Part 1 of the AM-001 study show that a 400 mg dose of Aramchol Meglumine achieved an area under the curve (AUC) nearly double that of Aramchol acid tablets [5] - The findings suggest that a once-daily regimen simplifies patient adherence and is expected to lower manufacturing costs [5][7] Strategic Outlook - Galmed's commitment to accelerating the clinical program for Aramchol Meglumine is reinforced by the positive data from the AM-001 study [7] - The company aims to leverage the enhanced bioavailability and robust patent protection of Aramchol Meglumine to drive growth and deliver innovative therapies for unmet medical needs [7][8] - Galmed is also pursuing opportunities to expand its product pipeline, targeting cardiometabolic diseases and gastrointestinal cancers [8]

Company Overview - Galmed Pharmaceuticals Ltd. is a clinical-stage biopharmaceutical company focused on liver, cardiometabolic diseases, and GI oncological indications [1][3] - The company is developing Aramchol for oncological indications outside of liver disease and is actively pursuing opportunities to expand its product pipeline [3] Financial Reporting - Galmed has filed its Annual Report on Form 20-F for the fiscal year ended December 31, 2024, with the U.S. Securities and Exchange Commission [1] - The report is accessible on the SEC's website and Galmed's Investor Relations website [2] Strategic Focus - The company aims to diversify its product pipeline specifically targeting cardiometabolic indications and other innovative product candidates [3]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of eve ...

Core Viewpoint - Galmed Pharmaceuticals has secured a new patent for the combination therapy of Aramchol and Resmetirom for treating non-alcoholic steatohepatitis (NASH), extending patent protection until September 2039, which positions the company to capitalize on the commercial potential of Aramchol in the growing NASH market [1][2][5]. Company Summary - Galmed Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing Aramchol for liver and fibro-inflammatory diseases, particularly NASH [12]. - The company believes that Aramchol's unique mechanism of action as a stearoyl-CoA desaturase-1 (SCD1) modulator provides a competitive advantage, making it suitable for combination therapies [6][7]. - The recent patent strengthens Galmed's intellectual property portfolio, enhancing its strategic flexibility for partnerships and commercialization [11]. Industry Summary - The global NASH treatment market is projected to grow from approximately $5.2 billion in 2022 to over $48 billion by 2035, indicating significant unmet needs and revenue opportunities [5]. - The industry is shifting towards combination therapies for NASH, as no single agent is expected to fully address the disease's complexities [4][10]. - Recent regulatory developments, including the FDA's approval of Resmetirom as the first drug for NASH patients with liver fibrosis, highlight the therapeutic potential in this area [4].

Core Insights - Galmed Pharmaceuticals has reported significant anti-fibrotic effects of Aramchol 300mg BID in patients with metabolic dysfunction associated steatohepatitis (MASH) [1][2] - The results from the Open-Label part of the Phase 3 trial (ARCON) have been published in the journal Hepatology, confirming the drug's efficacy through multiple objective measurements [1][5] - Aramchol is recognized as the most advanced down regulator of SCD-1 in clinical development, influencing fatty acid oxidation and reducing glycemic parameters [3] Company Overview - Galmed Pharmaceuticals is focused on developing Aramchol for liver diseases and exploring its potential for other fibro-inflammatory and oncological indications [6] - The company believes that combination therapy will be the optimal treatment for MASH, positioning Aramchol as a potent anti-fibrotic compound in the competitive landscape [4] Clinical Study Insights - The Phase 3 trial involved 150 patients with NASH and fibrosis, demonstrating a high rate of histological fibrosis improvement with Aramchol treatment [2] - The study utilized advanced digital pathology techniques, including AI analysis, to assess histological changes, enhancing the sensitivity and dynamic range of fibrosis scoring [1][5] Expert Commentary - Prof. Vlad Ratziu, a lead author of the study, emphasized the innovative mode of action of Aramchol and its potential for treating fibrotic MASH, highlighting the rigorous assessment methods used in the study [5]

Galmed Pharmaceuticals NASDAQ: GLMD, a little-known biotech stock, has become the center of attention as its shares have skyrocketed close to 400%. By 2 pm, the stock had traded over 80 million shares, a monumental leap from its average daily volume of just 75,000. GLMD The sudden surge begs the question: What's driving this small-cap biotech to such heights, and should investors consider jumping in? Get Galmed Pharmaceuticals alerts: First, What Is Galmed Pharmaceuticals? Galmed Pharmaceuticals Today Galme ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 Under the Securities Exchange Act of 1934 For the Month of August 2024 001-36345 (Commission File Number) GALMED PHARMACEUTICALS LTD. (Exact name of Registrant as specified in its charter) 16 Abba Hillel Road, Ramat Gan, Israel 5250608 (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under c ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 Under the Securities Exchange Act of 1934 For the Month of May 2024 001-36345 (Commission File Number) GALMED PHARMACEUTICALS LTD. (Exact name of Registrant as specified in its charter) 16 Tiomkin St. Tel Aviv 6578317, Israel This Form 6-K contains the quarterly report of Galmed Pharmaceuticals Ltd. (the "Company"), which includes the Company's unaudited condens ...