Durata Therapeutics, Inc. (NASDAQ: DRTX) today announced financial and corporate results for the quarter ended September 30, 2012.
“With the completion of patient enrollment in our two ongoing global Phase 3 clinical trials of dalbavancin, we remain on track to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the first half of 2013, pending results from these trials,” said Paul Edick, Chief Executive Officer of Durata Therapeutics, Inc. “Our financial results reflect our increase in spending as the studies draw to a close.”
Our significant recent accomplishments include the following:
- Completed target enrollment for both of our global Phase 3 clinical trials of dalbavancin.
- Received Qualified Infectious Disease Product (QIDP) designation for dalbavancin from the FDA, which provides Durata priority review by the FDA, eligibility for fast-track status, and extension of statutory exclusivity periods for an additional five years upon FDA approval of the product for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
- Completed QT study of dalbavancin, which indicated that dalbavancin had no clinically significant impact on cardiac conduction.
- Released in vitro study data that could help support a clinical development program to investigate dalbavancin for the treatment of pneumonia.
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