Cempra Withdraws Solithromycin Marketing Authorization Application in Europe
CEMPRA (CEMP)
US:NASDAQ Investor Relations:
ir.melinta.com/investor-relations
Company Research
Source: GlobeNewswire
CHAPEL HILL, N.C., March 28, 2017 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing differentiated anti-infectives for the acute care and community settings to meet critical medical needs in the treatment of infectious diseases, today announced that the company has withdrawn its marketing authorization application (MAA) seeking European Medicines Agency (EMA) approval of oral capsule and intravenous formulations of solithromycin for the treatment of community-acquired pneumonia in adults. Based on the Day 120 questions Cempra received from the EMA, the company believes additional data would be required. By withdrawing the MAA at this time, Cempra will conserve considerable financial resources, and it will allow the company to align its strategy to provide additional data to both the EMA and U.S. Food and Drug Administration (FDA) to support potential approval. “Our goal is to make solithromycin available in the EU to addr
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