Quick Facts
FONT-SIZE Plus   Neg
Share SHARE
mail  E-MAIL

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

12/21/2012 3:46 PM ET

Hemispherx Biopharma Inc. (HEB: Quote) 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.

Click here to receive FREE breaking news email alerts for Hemispherx Biopharma, Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Starbucks Corp. said Thursday after the markets closed that its second quarter profit rose 9.4% from last year, helped by higher revenue. The company's quarterly earnings per share came in line with analysts' expectations, but its quarterly revenue fell short of analysts' forecast. The world's largest specialty coffee retailer also raised its full year earnings outlook. Software giant Microsoft Corp. said Thursday after the markets closed that its third quarter profit fell 6.6% from last year, when results were boosted by special upgrade offer revenues. However, the company's quarterly earnings per share came in above analysts' expectations as did its quarterly revenue. Apple Inc. said Wednesday after the markets closed that its second quarter profit rose 7% from last year, as sales surged and margins improved amid strong sales of its iPhones. The company's quarterly earnings per share also came in above analysts' expectations as did its quarterly revenue. At the same time, the company gave a slightly downbeat revenue forecast for the current quarter.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.