BioCentury
ARTICLE | Company News

Cubist submits tedizolid NDA, reports 3Q13 earnings

October 23, 2013 12:48 AM UTC

Cubist Pharmaceuticals Inc. (NASDAQ:CBST) reported 3Q13 revenues that missed the Street on Tuesday and separately announced that it submitted an NDA to FDA for tedizolid to treat acute bacterial skin and skin structure infections (ABSSSI).

The NDA submission covers both IV and oral formulations of tedizolid. Next half, Cubist plans to submit an MAA to EMA. Both formulations have Qualified Infectious Disease Products (QIDP) designation from FDA to treat ABSSSI and hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP). The designations make the antibiotic eligible for an additional five years of market exclusivity, if approved. Cubist gained the second generation oxazolidinone, a bacterial protein biosynthesis inhibitor, through its acquisition of Trius Therapeutics Inc. last month (see BioCentury, July 30). ...