Shares of Cempra (CEMP) were down 6.9% to $4.05 in premarket trading on Tuesday on the heels of news that the Chapel Hill, N.C.-based company has pulled its marketing authorization application that seeks European Medicines Agency approval of oral capsule and intravenous formulations of solithromycin for the treatment of community-acquired pneumonia in adults.
Cempra said it believes additional data would be required based on the Day 120 questions it received from the EMA. "We believe the most efficient path to approval is to withdraw the MAA at this time and to resubmit it with the additional data requested by the FDA," said Cempra acting CEO David Zaccardelli in a statement.
Meanwhile, shares of Tesaro (TSRO) rose 5.9% to $166 after the company said yesterday that the U.S. Food and Drug Administration has approved Zejula (niraparib) for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer that are in a complete or partial response to platinum-based chemotherapy. Waltham, Mass.-based Tesaro said it anticipates launching Zejula in the U.S. in late April.