Nabriva Therapeutics plc (NBRV) Accused of Misleading Investors

According to the complaint against Nabriva Therapeutics plc (NASDAQ: NBRV) for alleged violations of the Securities Exchange Act of 1934 between November 1, 2018 and April 30, 2019, Nabriva announced the submission of its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for Intravnous CONTEPO. In the following months, Nabriva released press releases touting the progress of the NDA through the approval process. However, Nabriva failed to disclose quality control issues relating to its manufacturers' practices. In April 2019, Nabriva revealed that the FDA would not approve the NDA due to “issues related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers.” On this news, the Nabriva’s share price fell over 27% to close at $2.17 per share on May 1, 2019.