Last $6.88 USD
Change Today +0.08 / 1.18%
Volume 13.3K
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As of 12:35 PM 08/27/14 All times are local (Market data is delayed by at least 15 minutes).

galmed pharmaceuticals ltd (GLMD) Snapshot

Open
$6.88
Previous Close
$6.80
Day High
$6.90
Day Low
$6.80
52 Week High
03/13/14 - $18.73
52 Week Low
05/16/14 - $6.38
Market Cap
73.4M
Average Volume 10 Days
32.4K
EPS TTM
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Shares Outstanding
10.7M
EX-Date
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P/E TM
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galmed pharmaceuticals ltd (GLMD) Details

Galmed Pharmaceuticals Ltd., a clinical-stage biopharmaceutical company, focuses on the development and commercialization of therapeutics for the treatment of liver diseases and cholesterol gallstones. It is developing aramchol, which has completed a Phase IIa clinical trial for the treatment of non-alcoholic steato-hepatitis in patients who also suffer from obesity and insulin resistance. The company was founded in 2000 and is headquartered in Tel Aviv, Israel. Galmed Pharmaceuticals Ltd. operates as a subsidiary of Galmed International Ltd.

5 Employees
Last Reported Date: 03/11/14
Founded in 2000

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galmed pharmaceuticals ltd (GLMD) Key Developments

Galmed Pharmaceuticals Ltd. Reports Unaudited Consolidated Earnings Results for the First Half Ended June 30, 2014

Galmed Pharmaceuticals Ltd. reported unaudited consolidated earnings results for the first half ended June 30, 2014. For the six months, the company reported net loss of $3.9 million compared with a net loss of $1.6 million for the comparable prior year period. Net loss per share was $0.42 compared with $0.31 per share for the comparable prior year period, in each case not taking into consideration dilution resulting from net loss during both periods.

Galmed Pharmaceuticals Ltd. Announces FDA Clearance of IND of Armachol for the Treatment of Fatty Liver Disorders

Galmed Pharmaceuticals Ltd. announced that the U.S. Food and Drug Administration, cleared Galmed's Investigational New Drug, or IND, application. Such clearance will permit Galmed to conduct clinical trials of its product candidate, aramchol, in the United States for the treatment of fatty liver disorders. Galmed is initially developing aramchol for the treatment of Non-Alcoholic Steato-Hepatitis, or NASH. According to scientific literature, NASH is a chronic disease that affects approximately 12% of the population in United States and in certain European Union nations and its prevalence is expected to increase in parallel with increased rates of obesity and diabetes. There are currently no approved drugs to treat NASH. In connection with the FDA's clearance of Galmed's IND application, Galmed submitted a request to the FDA for the approval of a Fast Track Designation for aramchol. Fast Track Designation is a designation by the FDA that facilitates the development, and expedites the review, of drugs which treat a serious or life-threatening condition and fill an unmet medical need. Aramchol, a conjugate of cholic acid and arachidic acid, is a first in class member of a novel family of synthetic Fatty-Acid /Bile-Acid Conjugates or FABACs. FABACs are composed of endogenic compounds, orally administrated with potentially good safety and tolerability parameters. Galmed intends to begin, later this year, a multi-center, randomized, double-blind, placebo-controlled, dose-ranging Phase IIb clinical trial of aramchol in 240 NASH patients who also suffer from obesity and insulin resistance. The trial will have two co-primary end-points: significant reduction of liver fat content measured by NMRS and resolution of inflammation measured by 2 biopsies at the beginning and end of the study. This planned Phase IIb clinical trial for aramchol in NASH patients is in accordance with the study design recommended by the United Kingdom's Medicines and Healthcare Products Regulatory Agency, deemed acceptable by Germany's Bundesinstitut fur Arzneimittel und Medizinprodukte, or BfArM, deemed satisfactory by France's Agence Nationale de Securite du Medicament et des Produits de Sante, or ANSM, and confirmed as acceptable by the FDA. BfArM and ANSM also confirmed, in minutes of each of their respective scientific advisory meetings, that if successful, this Phase IIb trial may serve as a basis for Phase III pivotal trials of aramchol. To date, in a Phase IIa trial Galmed demonstrated that aramchol may reduce liver fat in a dose dependent manner, as evidenced by a statistically significant reduction of liver fat over a three-month treatment period of once-daily 300 mg doses of aramchol, and may induce positive trends of changes in several metabolic parameters. The trial's primary efficacy end point was a reduction in liver fat content, without consideration of inflammation or fibrosis. The secondary efficacy end points measured differences between the aramchol-treated group and the placebo group with respect to alterations of liver enzyme levels, levels of adiponectin, homeostasis model assessment scores, and endothelial function. All endpoints were met and there were no notable changes in biochemical, hematological, cardiovascular or other safety parameters, or any observable serious or drug-related adverse events in the 58 patients who completed the trial either during the three-month treatment period or during the subsequent recovery period. Galmed further confirmed the appropriateness of a single daily dose of aramachol by pharmacokinetic analysis.

Galmed Pharmaceuticals Ltd., Q2 2014 Earnings Call, Jul 25, 2014

Galmed Pharmaceuticals Ltd., Q2 2014 Earnings Call, Jul 25, 2014

 

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