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Galmed Liver Drug Aramchol Gets FDA's Fast-Track Review

Galmed Pharmaceuticals Ltd. (GLMD) Tuesday said the U.S. FDA has designated its liver drug aramchol for a Fast Track review. Shares of the clinical-stage pharmaceutical company gained 31 percent following the news.

The FDA has approved the expedited review of aramchol for the treatment of Non-Alcoholic Steato-Hepatitis, or NASH. NASH is a kind of liver inflammation caused by a buildup of fat in the liver. The fat causes inflammation of the liver, which may affect the proper functioning of the liver. NASH can get worse and cause scarring of the liver leading to cirrhosis. NASH affects about 12 percent of the population in United States and in certain European Union nations.

The Fast Track Designation expedites the review of drugs which treat a serious or life-threatening condition and fill an unmet medical need. There are currently no approved drug for NASH.

Commenting on the FDA approval, CEO Allen Baharaff said, "The Fast Track Designation of aramchol will allow for continued contact between Galmed and the FDA to optimally design aramchol's future studies, including clinical trials in the United States, and may enable Galmed to accelerate its development, FDA approval and the time to market."

Last month, Galmed had announced the successful completion of two six-month chronic toxicology studies of aramchol. Galmed intends to begin later this year, a Phase IIb clinical trial of aramchol in 240 NASH patients who also suffer from obesity and insulin resistance in Israel, Europe and certain Latin American countries.

GLMD is currently trading at $8.71, up $2.23 or 34.41%, on the Nasdaq.

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