SEC Form EFFECT filed by Galmed Pharmaceuticals Ltd.
| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | September 2, 2025 |
| Accession Number: | 0001493152-25-012441 | ||||||
| Submission Type: | POS AM | ||||||
| |||||||
| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | September 2, 2025 |
| Accession Number: | 0001493152-25-012441 | ||||||
| Submission Type: | POS AM | ||||||
| |||||||
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The top-line results showed that bioavailability of Aramchol meglumine 400mg and 200mg granules is considerably greater, higher by 5-fold and 3-fold respectively, that of the Aramchol free acid 300mg tablets The new unexpected PK profile allows for a once daily therapeutic regimen thus potentially improving long term adherence and expected to significantly reduce the drug cost of goods RAMAT-GAN, Israel, Nov. 18, 2025 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on liver, cardiometabolic, and gastrointestinal oncology indications, today announced meaningful top-line results from Galmed's AM-001 Study
DENVER, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Markets open this morning with a distinctly biotech-heavy narrative delivering milestone developments. Zymeworks and Jazz Drop Landmark Phase 3 Data: Ziihera Positioned as New HER2 Standard in First-Line GEA The biggest headline of the morning comes from Zymeworks (NASDAQ:ZYME), after partners Jazz Pharmaceuticals and BeOne Medicines unveiled positive top-line results from the Phase 3 HERIZON-GEA-01 study evaluating Ziihera (zanidatamab-hrii) in front-line HER2-positive gastroesophageal adenocarcinoma (GEA). Why it matters: This is the first Phase 3 trial to show superiority over the long-standing regimen trastuzumab + chemotherapy, positioning
The top-line results from the study showed that the 3-drugs' synergistic effect has the potential as a new fixed-dose combination treatment, enhancing the effect of Bayer's top selling cancer drug, Stivarga® (regorafenib); such combination could potentially become a life-cycle IP strategy when Stivarga's® main European and U.S. patents expires in August 2028 and July 2032, respectively.New patent applications (US 63/786,370 and US 63/915,832) have been submitted to USPTO.Metformin is typically the first-choice treatment for managing type 2 diabetes and is widely available in generic forms.The combination of Aramchol and Stivarga® is expected to enter phase 1b clinical trials early 2026 in m
Canaccord Genuity reiterated coverage of Galmed Pharmaceuticals with a rating of Buy and set a new price target of $21.00 from $20.00 previously
HC Wainwright & Co. reiterated coverage of Galmed Pharmaceuticals with a rating of Buy and set a new price target of $25.00 from $29.00 previously
6-K - Galmed Pharmaceuticals Ltd. (0001595353) (Filer)
6-K - Galmed Pharmaceuticals Ltd. (0001595353) (Filer)
6-K - Galmed Pharmaceuticals Ltd. (0001595353) (Filer)
SC 13G/A - Galmed Pharmaceuticals Ltd. (0001595353) (Subject)
SC 13G/A - Galmed Pharmaceuticals Ltd. (0001595353) (Subject)
SC 13G - Galmed Pharmaceuticals Ltd. (0001595353) (Subject)
TEL AVIV, Israel, Aug. 28, 2025 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for cardiometabolic diseases and GI oncological indications, reports financial results for the three and six months ended June 30, 2025 and recent developments. Recent Business Updates In August 2025, Galmed announced that it has adopted a digital asset management strategy as part of a new treasury investment policy and capital allocation initiative to enhance capital efficiency and drive shareholder value. Accordingly, the Company established a Crypto Committee of the Board, which is evaluating and, if appropriate, will oversee
TEL AVIV, Israel, May 22, 2025 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for cardiometabolic diseases and GI oncological indications, reports financial results for the three months ended March 31, 2025 and recent developments. Key Recent Developments Announced First Time Results in Oncology Studies: Aramchol Significantly Enhances Bayer's Regorafenib Effect in GI Cancer ModelsSigned Term Sheet for the Development of Novel Semaglutide Sublingual FormulationRaised $6.5 million since the beginning of 2025. Company's current cash balance is $20.1 millionFinancial Summary – First Quarter 2025 vs. First Quarte
TEL AVIV, Israel, June 1, 2023 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver and fibro-inflammatory diseases reports financial results for the three months ended March 31, 2023 and recent developments Recent Developments Initiated a new clinical program to evaluate its lead compound, Aramchol meglumine for the treatment of Primary Sclerosing Cholangitis (PSC), a rare disease for which there is no approved treatment;Phase 2 proof of concept PSC study to be conducted in collaboration with the Stravitz–Sanyal Institute for Liver Disease and Metabolic Health Virginia Commonwealth University;Formed a str