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Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of Peregrine Pharmaceuticals (NASDAQ: PPHM ) , a clinical-stage developer of monoclonal antibodies to treat cancer, galloped higher by as much as 30% after announcing that its lead drug, bavituximab, had been granted fast track designation and that a phase 3 study, known as Sunrise, had been initiated.
So what: The initiation of the phase 3 trial doesn't come as a huge shock to anyone, but the fact that bavituximab -- Peregrine's experimental second-line treatment for non-small-cell lung cancer -- received the fast track designation is where most of today's pop is coming from. The fast track designation, which is issued by the Food and Drug Administration, allows for more frequent communication between the FDA and the company in question, and can also lead to a priority review if/when Peregrine files for a new drug application for bavituximab.
Now what: Now we wait patiently for the data from the Sunrise trial, which will include approximately 600 different patients worldwide. In mid-stage trials, bavituximab's data was impressive – a more than doubling in median overall survival (12.1 months versus 5.6 months), a 1.2 month bump higher in progression-free survival to 4.2 months, and a more than doubling of the overall response rate to 16.5% -- but it was marred by the trustworthiness of a third-party clinical labs contractor. Investors will be looking for a no-frills study this time; but if Peregrine delivers it, the sky could be the limit.
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