Shares of Nabriva Therapeutics PLC
shot up 27% to pace the premarket gainers in active trading Tuesday, after the biotechnology company said its new drug application (NDA) for the oral and intravenous formulations of Xenleta, a treatment for community-acquired bacteria pneumonia, was approved by the Food and Drug Administration. Trading volume of over 1.3 million shares was already more than the full-day average of about 922,000 shares. “Today’s approval of XENLETA is a significant breakthrough in the collective fight against the growing threat of antimicrobial resistance and provides a desperately needed IV and oral empiric monotherapy treatment option for adults with CABP,” said Chief Executive Ted Schroeder. The company expects Xenleta to be available in mid-September through U.S. specialty distributors, and will have a wholesale acquisition price of $205 per IV patient treatment day and $275 per oral patient treatment day. The stock has slumped 7.5% over the past three months through Monday, while the S&P 500
has gained 2.9%.
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