Hemispherx is expecting an FDA decision Tuesday on the company's drug for chronic fatigue syndrome, Ampligen, based on a single study completed in 2004. The FDA refused to review the Ampligen application in 2007, but Hemispherx resubmitted the drug in 2008. The company has outstanding manufacturing problems related to Ampligen that have yet to be resolved, according to the company's SEC filings.
At various times over the years, Hemispherx has claimed Ampligen as a treatment for HIV, the ebola virus, avian flu, swine flu and smallpox.
Hemispherx sold stock to raise cash on May 11 and again on May 19, a strange move for a company confident about a positive decision on Ampligen next week.
OncoGenex shares took off May 14 after a research abstract for the firm's prostate cancer drug OGX-011 was released online in advance of the ASCO meeting. The interim data from a phase II study showed OGX-011 plus chemotherapy boosted survival over chemotherapy alone in patients with advanced prostate cancer.Rodman & Renshaw, an investment bank that caters to raising money for small-cap biotech companies, initiated coverage on OncoGenex with a buy rating, making the claim that OGX-011 could be a more effective prostate cancer drug than Dendreon's (DNDN) Provenge. OncoGenex finished the first quarter with $9.4 million in cash, which makes it highly likely that a follow-on financing deal will get done soon, perhaps before or right after the ASCO meeting, where additional OGX-011 data will be presented.