This week could be quite exciting, drug investors. We've got a trio of PDUFA dates coming up, followed with one more next week.
Of course, the Prescription Drug User Fee Act doesn't require the Food and Drug Administration to act on the date -- it's just sort of a hazy, general goal by which the agency should try to make up its mind. So we could have three decisions, or we might have none. At least it'll keep the day traders on their toes.
For more Foolish, longer-term investors, let's take a look at the potential winners -- and invest if the price seems right.
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As the agency has done so many times recently, it may come back with a complete response letter asking the companies to develop a Risk Evaluation and Mitigation Strategy (REMS), which would encourage doctors not to prescribe the drug off-label.
A delay and/or a restrictive label would be perfectly OK with sanofi-aventis
Given the life-threatening nature of HAE, the FDA gave Cinryze a six-month priority review, putting its PDUFA date on June 3. If ViroPharma does get the green light to market Cinryze as an acute treatment, it'll have a head start on Dyax, which received a complete response letter for its acute HAE drug, DX-88, in March. The delay was good news for ViroPharma, but Dyax should be able to get the drug on the market eventually.
Cinryze might also go head-to-head with CSL Behring's Berinert-P, which is already approved in other countries, and is up for review at the FDA for treating acute episodes of HAE.
Tell us what you think
Not interested in the extreme binary events that often have drastic effects on drugmakers' stock prices? You can still play along at home, by telling us what you think in the Motley Fool CAPS. Let us know whether you think the drug decisions will help these companies outperform the S&P500, or whether they're just duds. It's free to play, and best of all, you might get a few investment ideas from fellow Fools.
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Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. The Fool's disclosure policy really isn't sure what sitting outdoors in a bathtub has to do with erectile dysfunction.