A biotechnology company, which designs, optimizes and develops novel drugs that block key enzymes involved in cancer, cardiovascular diseases, autoimmune diseases, and viral infections.
BATS data provided in real-time. NYSE, NASDAQ and AMEX data delayed 15 minutes.
Real-Time prices provided by BATS. Market data provided by Interactive Data.
Company fundamental data provided by Morningstar. Earnings Estimates and Analyst Ratings provided by Zacks.
SEC Filings and Insider Transactions provided by Edgar Online.
Powered and implemented by Interactive Data Managed Solutions. Terms & Conditions
RSS Headlines
Fool UK
Recs
Expect FDA approval of its anti-viral and substantial orders thereafter.
At the moment this is an H1N1 flu play. Recent Statements by BARDA, HHS and the President's science advisors all indicate that HHS will purchase peramivir (an anti-viral, not a vaccine), which has demonstrated substantial anti-H1N1 efficacy when administered INTRAVENOUSLY, for the national staretigic stockpile this month. And last week the president earmarked $2.7 billion more in contingency funds, specifiying the purchase of anti-virals as one of the purposes for which the money will be used. So it is reasonable to assume that HHS, which is responsible for coming up with the detailed plan for the use of these funds, and which has clearly and explicity indicated that it is moving forward with the purchase of investigational intravenous antivirals for use this fall, will be using some of this money to increase the amount of peramivir in the stockpile. Simultaneously with that purchase or shortly thereafter I expect CDC to issue the guidance that will allow HHS to issue an Emergency Use Authorization for the use of INTRAVENOUS peramivir on hospitalized flu patients.
Many who are betting against Peramivir (and Biocryst) are relying on data that demonstrate that peramivir has insignificant efficacy when injected as an intramuscular. The data on efficacy when administered intravenously is much more positive, and peramivir may become the drug of choice for use in hospitalized patients, especially against H1N1 strains that are resistant to competing anti-virals.
September will tell the tale.