BioCentury
ARTICLE | Company News

Cempra falls on FDA's manufacturing concerns

October 28, 2016 7:00 AM UTC

Cempra Inc. (NASDAQ:CEMP) fell $4.94 (21%) to $18.50 on Friday, shedding more than $250 million in market cap, after it said FDA may not allow the company to use the API produced at an Indian facility for the commercial supply of Solithera solithromycin. The candidate is under FDA review to treat community-acquired bacterial pneumonia (CABP), with an advisory committee meeting scheduled for Nov. 4.

Cempra said it believes FDA's concerns are related to GMP systems at "several" facilities operated by Wockhardt Ltd. (BSE:532300). The company said it does not expect the issues to affect its planned launch of solithromycin for the 2017-2018 pneumonia season, and said it has accelerated production with another manufacturer. ...