Why Durata Therapeutics Inc. Shares Marched Higher

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What: Shares of Durata Therapeutics (UNKNOWN: DRTX.DL  ) , 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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  • Report this Comment On November 28, 2013, at 11:32 AM, sicnick wrote:

    Basher!!! This drug is 95% effective, can be administered at home & shortens Hospital stays making it more cost effective overall.. This article clearly states you are negative & I'm guessing you are shorting the stock. Happy thanksgiving from all the Longs...

  • Report this Comment On January 03, 2014, at 5:33 PM, Cannondale35 wrote:

    This compound has shown the potential to augment the efforts of hospitals to shift their paradigm of treatment to the outpatient setting and save money. The caveat will be how Dalvance (if approved) is priced. Durata is in a unique position to learn from the mistakes of Optimer (Dificid) and Cubist (Daptomycin). Optimer overpriced their drug, despite showing less recurrence and Cubist continues to price themselves out of the market with increasing the price (once again). Infectious disease physicians and pharmacy will restrict Dalvance if too expensive. Hopefully the share holders will recognize the value of bringing a novel therapy to market without pricing out of the stratosphere. We shall see?

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Related Tickers

12/31/1969 7:00 PM
DRTX.DL $0.00 Down +0.00 +0.00%
Durata Therapeutic… CAPS Rating: **