Cempra hammered on CRL for Solithera

Cempra Inc. (NASDAQ:CEMP) shares lost more than half their value this week after the company received a complete response letter from FDA for its NDAs for oral and IV Solithera solithromycin to treat community acquired pneumonia (CABP). Cempra shed 57% to $2.60 after it announced the news on Thursday; the stock regained $0.20 to $2.80 on Friday.

The company said the CRL recommended an additional safety study in about 9,000 patients to evaluate Solithera's potential for drug induced liver injury (DILI). The CRL also said that if approved, the fluoroketolide/macrolide antibiotic's label would include "adequate information" about the compound's potential for hepatotoxicity and limitations on its use, even in absence of new signals from the proposed safety study. The agency would also require post-approval safety monitoring...