Galmed Pharmaceuticals Ltd., a clinical-stage biopharmaceutical company, focuses on the development of therapeutics for the treatment of liver diseases. It develops Aramchol, an oral therapy, which is in Phase III study for the treatment of non-alcoholic steato-hepatitis (NASH) in patients with overweight or obesity and who are pre-diabetic or type-II-diabetes mellitus. The company also evaluates Aramchol through ARRIVE Study, a Phase IIa clinical trial with HIV-associated non-alcoholic fatty liver disease and lipodystrophy. In addition, it engages in the development of Amilo-5MER, a 5 amino acid synthetic peptide methionine, threonine, alanine, aspartic acid, and valine. Galmed Pharmaceuticals Ltd. has a research agreement with Gannex Pharma Co., Ltd. to develop a combination therapy of ASC41 (THR-beta agonist) and Aramchol (SCD 1 inhibitor) for the treatment of NASH; a research and development collaboration agreement with MyBiotics Pharma Ltd. to identify the selected microbiome repertoire associated with the response to Aramchol; and a license agreement with Samil Pharma. Co., Ltd. for the commercialization of Aramchol in the Republic of Korea. The company was founded in 2000 and is headquartered in Tel Aviv, Israel.
IPO Year: 2014
Exchange: NASDAQ
Website: galmedpharma.com
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6-K - Galmed Pharmaceuticals Ltd. (0001595353) (Filer)
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
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The paper re-iterates the significant anti-fibrotic effect of Aramchol 300mg BID in patients with metabolic dysfunction associated steatohepatitis (MASH)Data is confirmed using 3 objective measurements; NASH CRN, paired ranked reading, and Artificial Intelligence (AI) quantitative digital analysisContinuous histological fibrosis scores generated in antifibrotic trials by digital pathology images analysis (DIA) quantify antifibrotic effects with greater sensitivity and larger dynamic range than Conventional PathologyTEL AVIV, Israel, Sept. 25, 2024 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metab
Aramchol is the most clinically advanced, first-in-class, Stearoyl-CoA desaturase1 (SCD1) oral inhibitor, demonstrating in Ph2 and Ph3 (open label part) an excellent safety profile with metabolic and anti-fibrotic effects.Galmed raised an aggregate of $7.5 million in warrant exercises and drawdowns on its recently adopted equity lineTEL AVIV, Israel, Sept. 19, 2024 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for fibroinflammatory indications announced today that based on the recently published results from the Open-Label part of its Phase 3 NASH study, new scientific publications on the role of SCD1 as a cr
TEL AVIV, Israel, April 4, 2024 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and fibrotic diseases, today announced that it has filed its Annual Report on Form 20-F for the fiscal year ended December 31, 2023, with the U.S. Securities and Exchange Commission (the "SEC"). The report is available on the SEC's website, at www.sec.gov and Galmed's Investor Relations website, at https://galmedpharma.investorroom.com/sec-filings. Shareholders can obtain copies of Galmed's Annual Report on Form 20-F, free of charge, by making a request within a reasonable period of time to Galmed's Investo
TEL AVIV, Israel, March 15, 2024 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and fibrotic diseases announced today the grant of a European patent related to the use of a combination of Aramchol and Resmetirom (MGL-3196, REZDIFFRA) for the treatment of NASH/MASH and liver fibrosis. The patent was granted in France, Germany, Italy, the Netherlands and the United Kingdom and the approval of the patent in the United States and other countries is pending. With this latest patent, Galmed is strengthening and extending the patent protection of its lead compound, Aramchol, until September 2039.
TEL AVIV, Israel, Nov. 20, 2023 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and fibrotic diseases, announced today a delay of at least 6 months in the initiation of its Primary Sclerosing Cholangitis (PSC) Ph 2a Study. In May 2023, Galmed announced the pivoting of its clinical program to evaluate the safety and efficacy of its lead compound, Aramchol meglumine, for the treatment PSC. All work was designed to ensure the initiation of a proof-of-concept Phase 2a study in the last quarter of 2023. Prior to the initiation of the Ph 2a study, Galmed had planned to complete a Ph1 pharmacokin
TEL AVIV, Israel, Sept. 26, 2023 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and fibrotic diseases announced today the allowance of a Japanese patent related to treatment of pulmonary and dermal fibrosis. A similar patent was already granted in Mexico. The approval of the patent in the US and the rest of the world is pending. With this latest patent, Galmed is strengthening and extending the patent protection of its lead compound, Aramchol, until November 2037. Previously, Galmed reported results showing significant anti-fibrotic effects of Aramchol in a pre-clinical model of lung
TEL AVIV, Israel, Sept. 22, 2023 /PRNewswire/ —Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and fibrotic diseases, today announced that the Company received a letter from the Nasdaq Listing Qualifications (the "Letter"), indicating that the Company is not in compliance with the minimum bid price requirement for continued listing set forth in Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum bid price of $1.00 per share. Further, the Rules also provide the Company a compliance period of 180 calendar days to regain compliance. According to the Letter, the Company has from
TEL AVIV, Israel, July 14, 2023 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and fibrotic diseases, announced today that it has entered into securities purchase agreements with two institutional investors to purchase 5,600,000 of its ordinary shares (or pre-funded warrants in lieu thereof) and warrants to purchase 5,600,000 ordinary shares at a combined purchase price of $1.25 per ordinary share and accompanying warrant (the "Offering"). The gross proceeds of the Offering to the Company, before placement agent fees and estimated offering expenses, are expected to be approximately $7.0 mi
OnKai's AI models redefine the methodologies and economics of clinical trials TEL AVIV, Israel, July 10, 2023 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and fibrotic diseases, is delighted to announce the first step in its strategic partnership with OnKai, where OnKai will apply its artificial intelligence (AI), models for enrollment and execution of clinical trials in underserved communities, starting with Galmed's innovative Primary Sclerosing Cholangitis (PSC) clinical development program. PSC is a rare, severe, chronic disease where progression is predominantly determined by biliar
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
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
TEL AVIV, Israel, Aug. 4, 2022 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of Aramchol™, an oral therapy for the treatment of nonalcoholic steatohepatitis, or NASH, fibrosis and other fibrotic indications, provides today a business update and reports financial results for the three and six months ended June 30, 2022. Recent Developments Discontinuing the Open Label Part of the ARMOR study having reached its objectives while refocusing research and development on advancing Aramchol for new anti-fibrotic indications.Implementing a cost reduction plan that includes reduction in headc
TEL AVIV, Israel, May 17, 2022 /PRNewswire/ —Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic, fibrosis and inflammatory diseases reports financial results for the three months ended March 31, 2022. Recent Developments Announced that Company's clinical development strategy will expand into new anti-fibrotic indications to maximize the potential of its lead compound, Aramchol while at the same time discontinuing the Open Label Part of the Armor Study having reached its objectives.Company evaluating its strategic alternatives and its structuring to best enhance shareholder value and achieve its goals.Fina
- Conference Call and Webcast Today at 8:30 a.m. ET / 5:30 a.m. PT - TEL AVIV, Israel, May 2, 2022 /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 Aramchol™, an oral therapy for the treatment of nonalcoholic steatohepatitis, or NASH and fibrosis, provides today updated information on the Company's scientific and clinical development programs and reports financial results for the three and twelve months ended December 31, 2021. Recent Clinical & Scientific Developments Announced positive interim results from Open-Label part of the ARMOR study sh
TEL AVIV, Israel, April 26, 2022 /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 Monday, May 2, 2022, to provide an update on current developments with respect to its clinical programs for Aramchol™ and to discuss financial results for the fourth quarter and year ended December 31, 2021. Conference Call & Webcast: Monday May 2, 2022, 8:30 AM ETToll Free:
TEL AVIV, Israel, Nov. 8, 2021 /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 Aramchol™, an oral therapy for the treatment of nonalcoholic steatohepatitis, or NASH and fibrosis, provides today updated information on the Company's scientific and clinical development programs and reports financial results for the three and nine months ended September 30, 2021. Recent Clinical & Scientific Developments Announced positive results of the
-- Updated liver histology data from first 20 patients show 60% fibrosis improvement by at least 1 stage as early as 24 weeks, data will be presented at AASLD Late Breaker Presentations -- -- Statistically significant reductions in biomarkers associated with liver fibrosis including ALT, AST, Fib-4 and ProC-3 was also observed in ~ 50 patients -- -- Results are an early indication that higher dose of Aramchol could provide statistically and clinically meaningful effect on fibrosis in the double-blind placebo controlled regulatory part for submission of an NDA under Sub-part H-- Galmed's management team will host a conference call and webcast to provide an update on current developments w
TEL AVIV, Israel, Nov. 1, 2021 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and inflammatory diseases announced today results from the first 16 patients in the Open-Label Part of the ARMOR Phase 3 study who underwent a scheduled post-baseline biopsy. End of treatment biopsies were performed for 8 patients at 24 weeks, 6 at 48 weeks and 2 at 72 weeks. Altogether treatment with Aramchol reduced fibrosis progression in 15 out of the 16 patients. 8 out of the 16 patients (50%) showed fibrosis improvement by ≥1 stage (4 of 8 after 24 weeks, 3 of 6 after 48 weeks and 1 of 2 after 72 weeks). I
TEL AVIV, Israel, Aug. 5, 2021 /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 Aramchol™, an oral therapy for the treatment of nonalcoholic steatohepatitis, or NASH and fibrosis, provides today updated information on the Company's scientific and clinical development programs and reports financial results for the three and six months ended June 30, 2021. The Company will host a conference call and webcast at 08:30 ET today. Recent Clinical & Scientific Developments The FDA agreed with Galmed's plan to use Aramchol meglumine in the randomized double-
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- SEC Filing
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