Hemispherx had investors excited this week with the news of an analyst call on the company's flu initiatives, but the upward trend didn't last long. After skyrocketing more than 55 percent earlier this week, the company's stock dropped 27 percent this morning and is now trading at $2.50. What's causing all of this movement?
The drug developer has been playing the waiting game with the FDA on its lead drug candidate Ampligen for some time now. The FDA's review of the chronic fatigue drug was extended in February and again in May. Hemishperx said in May the agency would need a couple more weeks. Weeks have turned into months as the Philadelphia, PA-based biotech now says the FDA will likely not make a decision until the Fall.
During today's analyst call, the company tried to soothe investors by touting initiatives to evaluate the antiviral as a H1N1 treatment. Hemispherx CEO Dr. William Carter told analysts that the company expects to spend "tens of millions of dollars" on evaluating Ampligen as a booster for flu vaccines. Studies are planned or underway in the United States, Australia and the Pacific Rim, the Philadelphia Business Journal reports.
But some are skeptical of the PR attempt. Ampligen has been in development for three decades now, evaluated for a range of diseases, including AIDS, cancer and the avian flu. The Street's Adam Feuerstein points out that for all its talk, Hemispherx doesn't have much to show for it. Although the company didn't receive an H1N1 vaccine contract from the U.S. government, Carter has been quoted as saying the Japanese government and medical community are all over Ampligen and has stopped working on all other adjuvants. But there have been no announcements about contracts or partnerships to date--and no new data, from Hemispherx or its partners.