BioCentury
ARTICLE | Company News

FDA issues Ampligen complete response letter

February 6, 2013 1:52 AM UTC

Hemispherx Biopharma Inc. (NYSE-M:HEB) said late Monday that FDA issued a complete response letter for Ampligen rintatolimod to treat chronic fatigue syndrome (CFS). According to the company, FDA is requesting Hemispherx conduct at least one additional clinical trial, complete non-clinical studies and perform data analyses. Hemispherx said it will request a meeting with FDA before submitting a formal appeal of the decision. Hemispherx fell $0.04 (15%) to $0.22 on Tuesday.

Last December, FDA's Arthritis Advisory Committee voted 8-5, with one abstention, that Hemispherx failed to demonstrate sufficient efficacy and safety of Ampligen to treat CFS. The product is a double-stranded RNA antiviral agent that agonizes toll-like receptor 3 (TLR3). ...