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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 Durata Therapeutics (NASDAQ: DRTX ) , a biopharmaceutical company focused on developing therapies to treat infectious diseases and illnesses, jumped as much as 20% after announcing the acceptance of its experimental drug dalvance for priority review by the Food and Drug Administration.
So what: According to the press release, the FDA accepted the new drug application for Durata's dalvance for the treatment of acute bacterial skin and skin structure infections (ABSSSI) while granting it a priority review, which should speed along the review process to within a six-month time frame, as opposed to the standard 10-month review process. In two late-stage trials, Durata's dalvance was paired up against Vancomycin, and was demonstrated to be non-inferior to the current standard of treatment. Furthermore, the Vancomycin control arm received the therapy twice daily for two weeks, whereas Durata's dalvance is just two intravenous injections given one week apart.
Now what: I'm not quite certain that I'm as excited about today's priority review acceptance as shareholders in Durata are, but I can clearly see how this could be a transformative drug, if approved, considering the convenience factor associated with the therapy. With dalvance meeting its primary endpoint of non-inferiority, and the secondary endpoint supportive of the fact that dalvance could work as an alternative ABSSSI treatment, I'm certainly leaning in favor of its experimental therapy being approved. Now, all we have to do is wait and cross our fingers that the FDA concurs.
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