Nabriva Therapeutics plc

On April 30, 2019, the Company revealed that it had received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) for its New Drug Application (“NDA”) for CONTEPO™ (fosfomycin) for injection for the treatment of complicated urinary tract infections. According to the CRL, the Company had to address certain “issues related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers” before the FDA would approve the NDA. On this news, the Company’s share price fell $0.82 per share, more than 27%, to close at $2.17 per share on May 1, 2019, thereby injuring investors.

The complaint filed in this class action alleges that the Registration Statements were false and misleading and omitted to state material adverse facts. Throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that the Company’s manufacturers failed to meet good manufacturing practices; (2) that these manufacturers would be subject to inspections by the FDA in connection with the Company’s NDA; (3) that, as a result of the manufacturing deficiencies, the Company’s NDA for CONTEPO was unlikely to be approved by the FDA; and (4) that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects, were materially misleading and/or lacked a reasonable basis.