Durata Therapeutics (NASDAQ: DRTX) today announced results from its QT study of the company’s lead product candidate, dalbavancin. Dalbavancin is currently under investigation in two ongoing, global, Phase 3 clinical trials for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The QT study data, presented at the 52 nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), showed that in this study dalbavancin had no clinically significant impact on cardiac conduction.
The U.S. Food and Drug Administration (FDA) generally requires thorough QT studies for new chemical entities due to the risk of heart arrhythmias associated with some pharmaceutical products. The results observed in Durata’s definitive study are intended to satisfy the FDA’s requirements in this area. These data will be included in the company’s New Drug Application (NDA) for dalbavancin, which Durata anticipates submitting with the FDA in the first half of 2013.
For more information on this and four other Durata-related studies presented at ICAAC 2012, visit www.duratatherapeutics.com/media-center/publications.
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV