Hemispherx Biopharma says FDA denies application for Ampligen as chronic fatigue treatment

Hemispherx gets FDA denial on Ampligen treatment

PHILADELPHIA — Hemispherx Biopharma Inc. said Tuesday 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.