Boston, MA 06/11/2014 (wallstreetpr) – Orexigen Therapeutics, Inc. (NASDAQ:OREX) shares declined 12% as review of its experimental obesity treating drug was extended three months.
Steepest Fall
The U.S. Food and Drug Administration delayed its decision on Orexigen’s weight loss drug, NB32, also called Contrave, by three more months. The agency is to announce its decision on September 11, 2014, causing the drug maker to fall steepest in three years. Shares of Orexigen Therapeutics, Inc. (NASDAQ:OREX) fell to $5.65 in pre market trading and later down to $5.45, which is Orexigen’s largest intraday fall since June, 2011.
The FDA seeks to work a deal out with the company on after marketing commitments related to accessing the effect of the drug on the heart. While the agency issued a date in September, Osaka, Japan based drug manufacturer, Takeda Pharmaceutical Co Ltd (TYO:4502) would beat Orexigen. The Asia’s biggest drug maker plans to market its weight loss medicine sooner in the U.S. However, Orexigen’s Chief Executive Officer, Michael Narachi, said that the company finds encouragement with the high level of involvement with the agency. The company is hopeful of coming to an agreement on after marketing obligations.
Safety Concerns
Orexigen is undertaking a study evaluating cardiac patients who are either prone to heart diseases or are diagnosed with diabetes. Orexigen Therapeutics, Inc. (NASDAQ:OREX)’s application for the approval of the drug includes safety and cardiovascular dataset obtained from a trial, called Light Study, which was conducted on 8,900 individuals.
The FDA has already approved weight loss drugs from two other biopharmaceutical companies in 2012. The pills came from Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) and Eisai Co., Ltd (TYO:4523), which sell the drug Belviq and VIVUS, Inc. (NASDAQ:VVUS) which markets Qsymia. The concerned companies are evaluating the effects of their respective drugs on the heart. All the three drugs were previously rejected by the FDA due to safety issues.
