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0.0173913043478261 -0.0434782608695653 -0.0260869565217392 -0.0347826086956522 -0.0173913043478261 -0.0782608695652175 -0.0782608695652175 -0.065217391304348
Stock impact report

Nabriva Therapeutics Announces European Medicines Agency (EMA) Validation of Marketing Authorization Application for Lefamulin

Nabriva Therapeutics plc - Ordinary Shares (NBRV) 
Last nabriva therapeutics plc - ordinary shares earnings: 3/12 04:01 pm Check Earnings Report
US:NASDAQ Investor Relations: investors.nabriva.com/investor-relations
Company Research Source: GlobeNewswire
DUBLIN, Ireland, June 24, 2019 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, today announced that the European Medicines Agency (EMA) has determined that the Company’s Marketing Authorization Application (MAA) for the intravenous (IV) and oral formulations of lefamulin, a potentially first-in-class, semi-synthetic pleuromutilin antibiotic for the treatment of community-acquired pneumonia (CAP) in adults 18 years of age and older, is valid. Validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process and an opinion of the EMA Committee for Medicinal Products for Human Use (CHMP) is anticipated in the next 12 to 15 months. The EMA’s review of the application will follow the centralized marketing authorization procedure. If approved by the EMA, lefamulin will receive marketing authorizati Show less Read more
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