On March 25, 2013, Trius Therapeutics (TSRX) announced top-line results from the ESTABLISH-2 phase 3 clinical trial of tedizolid phosphate for the treatment of acute bacterial skin and skin structure infections (ABSSSI), including methicillin resistant Staphylococcus aureus (MRSA). Results show that EASTABLISH-2, an intravenous (IV) to oral transition study, met the primary and key secondary endpoints for both U.S. U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regulatory guidelines for ABSSSI, and confirm the previous data from the ESTABLISH-1 all oral dose phase 3 trial.
We expect to see additional data at the Future Leaders in Biotech conference early April 2013 and via a late breaker presentation at ECCMID mid-April 2013. Management hopes to be in position to present a full analysis from ESTABLISH-2 at ICAAC in September 2013. We believe the company will be in position to file the new drug application (NDA) with the U.S. FDA by October 2013. Guidance is to file the marketing authorization application (MAA) seeking approval in the European Union during the first quarter of 2014.
Zacks Investment Research is reiterating its 'Buy' recommendation on shares of Trius following the solid top-line data from ESTABLISH-2. We see a partnership for the European commercialization of tedizolid as the single biggest catalyst for the shares in 2013. We believe the stock is well-positioned, with over $80 million in cash and investments, to continue its solid run into the presentation of the full data in September 2013 and the U.S. NDA filing in October 2013. Our price target is $12 per share.
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