Israeli biotech company Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) has announced that the US Food and Drug Administration (FDA) has awarded Fast Track Designation to its drug candidate aramchol for the treatment of Non-Alcoholic Steato-Hepatitis, or NASH. Following the announcement the share price rose 38.58% to $8.98 on Tuesday, giving a market cap of $99.12 million.
Galmed successfully held its Nasdaq IPO in March raising $38 million at a company value of $137 million, after money.
Galmed intends to begin a Phase IIb clinical trial of aramchol later this year in 240 NASH patients who also suffer from obesity and insulin resistance in Israel, Europe and Latin America.
Galmed 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 US, and may enable Galmed to accelerate its development, FDA approval and the time to market."
Published by Globes [online], Israel business news - www.globes-online.com - on September 24, 2014
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