According to the Complaint, Nabriva Therapeutics plc is a biopharmaceutical company that purports to develop novel antiinfective agents to treat serious infections. One of the Company’s product candidates is CONTEPO, an epoxide antibiotic developed by Zavante Therapeutics (“Zavante”), which the Company acquired in July 2018.
The Complaint alleges that 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, the Complaint alleges 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.
On May 24, 2019, the Court issued an Order consolidating cases. The Court issued an Order appointing Lead Plaintiff and Counsel on July 22. Lead Plaintiff filed a consolidated amended Complaint on September 20. On September 23, Lead Plaintiff corrected the consolidated amended Complaint.