Plus   Neg

FDA Panel Rejects Hemispherx's Ampligen For Chronic Fatigue Syndrome; Stock Down

Hemispherx Biopharma Inc. (HEB) announced the outcome of the meeting of the Arthritis Advisory Committee of the U.S. Food and Drug Administration on the New Drug Application or "NDA" for Ampligen for Chronic Fatigue Syndrome or "CFS".

The vote was 8 to 5 against recommending the approval of Ampligen. However, the Advisory Committee backed safety profile of Ampligen.

Hemispherx said it is committed to the Ampligen clinical development program and to bringing Ampligen to market to ease the suffering of those seriously afflicted with CFS. The company said it will also continue to work closely with the FDA to support the review of this investigational compound. Hemispherx will seek to do everything necessary to confirm in a scientifically rigorous manner that Ampligen is a safe and effective treatment for CFS.

The Prescription Drug User Fee Act ("PDUFA") review goal for the FDA to complete its review of the NDA is February 2, 2013.

HEB is currently trading at $0.28, down $0.08 or 21.39 percent.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Starbucks wants to be more efficient but it is risking the fragile loyalty of its most devoted customers. The ubiquitous chain plans a major push to get coffee lovers to use its mobile app to place their orders, but regulars prefer to buy their lattes by waiting in the queue. According to reports,... Taco Bell, the Mexican fast-food chain owned by Yum Brands Inc. (YUM), Thursday said it will start selling tortilla chips in grocery and convenience stores starting May. The chips will be available in Fire and Mild sauce packet flavors and also in a Classic flavor. "This launch of our first line... Meredith Corp. said Wednesday that it has decided to explore the sale of its Time, Sports Illustrated, Fortune, and Money brands. In addition, the company will cut 1,000 jobs over the next ten months as part of its plan to realize cost synergies from its acquisition of Time Inc. Further, Meredith has notified about 200 employees that their positions have been eliminated.
comments powered by Disqus
Follow RTT