Galmed Pharmaceuticals Ltd (GLMD) Surged 37.8% After FDA Approval for Fast Track Designation of NASH Drug

Galmed Pharmaceuticals Ltd (GLMD)

It was an excellent day for Galmed Pharmaceuticals Ltd (NASDAQ:GLMD) with a 37.81 percent increase in its share prices closing at $8.93. Galmed Pharmaceuticals Ltd (NASDAQ:GLMD) announced that the biopharmaceutical has received fast track designation for its NASH treatment drug, Aramchol, from the FDA.

Fast Track Designation is given to the drugs developed for the treatment of serious health conditions and it facilitates as well as accelerates the overall review process of the drug. Nearly 12% people in the U.S. and European nations suffer from NASH, chronic disease, with higher prevalence in regions with growing obesity rate.

Galmed Pharmaceuticals Ltd (GLMD)

Allen Baharaff, CEO of Galmed Pharmaceuticals Ltd (NASDAQ:GLMD), 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.”

Galmed Pharmaceuticals Ltd (NASDAQ:GLMD) plans to start a study on 240 NASH patients concerning phase IIB clinical trial of aramchol and the patients for the study included ones with obesity and resistance against insulin. The study will start later this year and would include patients from Israel, some Latin American countries, and Europe.

Galmed Pharmaceuticals Ltd (NASDAQ:GLMD) announced first half 2014financial results with net cash and cash equivalents of $37.4 million and net loss of $3.9 million in the period. The net loss per share was $0.42 for the period. The company completed several notable milestones during the period along with Phase IIB trial preparation of aramchol and the company is likely to report results by the third quarter of 2015. Galmed Pharmaceuticals Ltd (NASDAQ:GLMD) has a market cap of $71.93 million with 18% institutional ownership.

This article has been written by Prakash Pandey.

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