Durata Therapeutics, Inc. (NASDAQ: DRTX), a pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses, today announced financial and corporate results for the quarter ended June 30, 2012.
“We are pleased with the rate of patient enrollment in our ongoing Phase 3 clinical trials for our lead product candidate, dalbavancin, and continue to anticipate submitting a New Drug Application with the U.S. Food and Drug Administration in the first half of 2013,” said Paul Edick, Chief Executive Officer of Durata Therapeutics, Inc. “As anticipated, our research and development costs have increased substantially over the prior-year period as we move towards completion of our Phase 3 clinical trials.”
Our significant recent accomplishments include the following:
- Completed our initial public offering, resulting in approximately $73.9 million of net proceeds, after deducting underwriting discounts and commissions, or approximately $71.4 million after the payment of $2.5 million of other offering expenses payable by us.
- Progressed our ongoing Phase 3 clinical trials for our lead product candidate, dalbavancin, for the treatment of patients with acute bacterial skin and skin structure infections, or abSSSI.
- Passed the 60% enrollment level needed for our independent data monitoring committee, or DMC, interim analysis of the pooled and blinded early response rate and patient enrollment needed to maintain our 90% power calculation in each of our ongoing Phase 3 clinical trials. In the first trial, the DMC analysis indicated that we did not need to increase our enrollment target. In the analysis of the second trial, the DMC recommendation was to add 184 patients to our enrollment target. Based on our current enrollment rate, we do not expect this to cause any change in our previously disclosed timing of data availability or New Drug Application filing.
- Added Lisa Giles, CEO & President of Giles & Associates and former Vice President of Strategy and Development at G.D. Searle & Company, as an independent director, effective August 3, 2012.
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