Hemispherx battered after FDA rejects Ampligen NDA

Hemispherx BioPharma was dealt a heavy blow yesterday, watching its already battered share price plunge 44 percent after the developer announced that the FDA demanded to see more information from a new trial of its therapy for chronic fatigue syndrome before making a final decision on the NDA.

Hemispherx (HEB) says that regulators want at least one more trial to look at efficacy and safety for Ampligen, augmenting data from two studies it has already run. Those earlier trials, the FDA told Hemispherx, "did not provide credible evidence of efficacy."  That's not what investors wanted to hear, and Hemispherx shares slid 44 percent in extended trading last night, dropping 53 cents to 67 cents.

As TheStreet's Adam Feuerstein notes, the FDA's action amounts to a "staggering blow" capping a 20-year quest to gain an approval for the drug, which has been tested for a variety of ailments. Another late-stage trial could easily require hundreds of patients and prove to be very expensive. Its earlier Phase III took six years to wrap. The FDA also said that Hemispherx needed to resolve outstanding inspection issues at the facility used to manufacture Ampligen.

Nevertheless, Philadelphia-based Hemispherx showed no sign of backing away from the drug. "Management is pleased to have received specific advice on the remaining issues and is looking forward to making a thorough but expedited response its top priority, and plans to take all appropriate steps to seek approval and commercialization of Ampligen," the company said in its release.

- check out the Hemispherx statement
- read the article from TheStreet
- here's the Bloomberg piece