PHILADELPHIA (AP) – Hemispherx Biopharma Inc. said the Food and Drug Administration declined approval for the biotechnology company’s experimental intravenous drug Ampligen as a treatment for chronic fatigue syndrome.
The company said the FDA cited two key studies as not proving the drug is effective and recommends an additional study. Also, the FDA noted manufacturing issues that need to be resolved. Hemispherx is seeking an expedited meeting with the FDA to discuss options.
Shares of Hemispherx fell 59 cents, or 49 percent, to 61 cents in premarket trading Wednesday. The stock closed at $1.20 during the regular trading session Tuesday.
Date: December 2, 2009
Source: Associated Press
Filed Under: Drug Discovery