logo
Share SHARE
FONT-SIZE 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
Computer and printer maker Hewlett-Packard Co. said Thursday after the markets closed that its second quarter profit fell 21% from last year, hurt by lower revenue and costs related to the planned separation of the company. However, the company's quarterly earnings per share, excluding items, came in above analysts' expectations, but its quarterly revenue fell short of analysts' forecast. Accounting software maker Intuit reported a plunge in third-quarter profit, hurt by impairment charges, even as results topped Wall Street estimates, driven by growth in small business segment amid a strong tax season. Struggling teen-apparel retailer Aeropostale Inc. (ARO), Thursday said its first-quarter loss narrowed from a year ago, driven largely by stronger margins even as revenues continued to plunge dropped. Nevertheless, the company lost almost one-fifth of its market value in after-hours trade, with the...
comments powered by Disqus
RELATED NEWS
Trade HEB now with 
Follow RTT