About Galmed Pharmaceuticals Ltd. is a clinical stage drug development biopharmaceutical company for liver, metabolic and inflammatory diseases. Its lead compound, Aramchol™, a backbone drug candidate for the treatment of NASH and fibrosis is currently in a Phase III registrational study.
--Galmed Pharmaceuticals Ltd., a clinical-stage biopharmaceutical company focused on the development of Aramchol, a liver targeted, oral, SCD1 modulator, currently in a Phase 3 clinical trial for
26, 2019 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of the liver targeted SCD1 modulator Based on Galmed's regulatory and scientific review of relevant FDA guidance and precedents, the Company's assessment is that this change during Phase 3 could be considered acceptable provided According to Galmed Pharmaceuticals, the results “showed a statistically significant reduction in liver fat by MRS with Aramchol 400mg vs. placebo (p=0.0450) and not with 600mg (p=0.0655).” >>Vical Inc. Reports Failed Phase 2 Trial of Herpes Vaccine The results will also help to determine the primary endpoint for the Phase 3 trial of Aramchol and be able to provide support for a marketing 2021-03-18 2021-03-16 2019-04-09 4 Galmed at a Glance • Clinical stage biopharma company with two lead assets in development o Aramchol - in Phase 3 for NASH and fibrosis o Amilo - 5 MER - Phase 1 - ready for acute and chronic 2020-09-10 A Phase 3, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With Nonalcoholic Steatohepatitis (NASH) With Open-Label Part to Evaluate the Safety, PK and Treatment Response Kinetics of Aramchol. The ARMOR Study: Actual Study Start Date : September 23, 2019 These new data are particularly important for the patients enrolling in our ongoing ARMOR Phase 3/4 study who are overweight the timing and cost of Galmed's planned pivotal Phase 3/4 The results will allow Galmed to meet with regulators as soon as possible and discuss a pivotal Phase 3 study design, Galmed CEO Allen Baharaff said. The company’s shares were up 220 percent at Galmed Pharmaceuticals Announces Successful Completion of End of Phase 2 Meeting With FDA and Plan for Start of Phase 3, Stocks: NAS:GLMD,FRA:GPH,STU:GPH, release date:Apr 09, 2019 2018-01-08 Galmed will also present clinical data on the rationale for the Phase 3/4 dose selection and its potential increased efficacy. "At this year's Liver Meeting, we look forward to sharing new mechanistic data that will emphasize the role of Aramchol in the disease progression, treating multiple aspects of NASH including also normalization of glucose metabolism.
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Bile acid receptor agonist. Obeticholic acid. Intercept Pharmaceuticals. Phase 3. Active. SCD1 regulator.
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P = 0.02. P = 0.0514. 10 Sep 2020 10 oct. 2019 Les résultats cliniques intermédiaires de l'essai de phase III sur mille et d' Allergan, les résultats en phase clinique plus précoce de Galmed, 26 nov. 2019 l'essai clinique de phase 3 Resolve-it évaluant l'elafibranor de Genfit Galmed et Tobira, également présents dans les NASH, ainsi qu'aux 12 Jun 2018 support a phase 3 trial and a Food and Drug Administration marketing application.
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General and administrative expenses remained flat at $1.3 million. (See Galmed stock analysis on TipRanks) Earlier this week, Galmed announced the treatment of the first subject in the First-in-Human Phase I clinical trial evaluating Amilo-5MER, designed for the treatment of chronic inflammatory diseases.
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Galmed Pharmaceuticals successfully completed its End-of-Phase 2 meeting with the FDA discussing the future development of Aramchol. A general agreement was reached on key aspects of the Phase 3/4 development and registration plan for Aramchol and on the pivotal registration study ARMOR.
About Galmed Pharmaceuticals Ltd. is a clinical stage drug development biopharmaceutical company for liver, metabolic and inflammatory diseases. Its lead compound, Aramchol™, a backbone drug candidate for the treatment of NASH and fibrosis is currently in a Phase III registrational study. About Galmed Pharmaceuticals Ltd. Galmed Pharmaceuticals Ltd. is a clinical stage drug development biopharmaceutical company for liver, metabolic and inflammatory diseases. Our lead compound, TEL AVIV, Israel, March 11, 2021 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of Aramchol, a liver targeted, oral, SCD1 modulator, currently in Phase 3 clinical trial for the treatment of nonalcoholic steatohepatitis (NASH) and fibrosis announced today that it will host a conference call and webcast on Thursday, March 18, 202 1, to provide an update on current developments with A Phase 3, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With Nonalcoholic Steatohepatitis (NASH) With Open-Label Part to Evaluate the Safety, PK and Treatment Response Kinetics of Aramchol.