Nabriva Therapeutics plc
- Company Name
- Nabriva Therapeutics plc
- Stock Symbol
- Class Period
- November 1, 2018 to April 30, 2019
- Motion Deadline
- July 8, 2019
- Southern District of New York
The complaint charges Nabriva and its Chief Executive Officer with violations of the Securities Exchange Act of 1934. Nabriva is a biopharmaceutical company that develops novel anti-infective agents to treat serious infections. One of the Company’s lead drug candidates is CONTEPO™ (fosfomycin), an epoxide antibiotic for use in treating complicated urinary tract infections. In November 2018, Nabriva filed a New Drug Application (“NDA”) with the FDA to seek marketing approval for CONTEPO.
The complaint alleges that throughout the Class Period, defendants made materially false and misleading statements and/or failed to disclose material adverse facts about the Company’s business, operations and prospects, including that the Company’s manufacturers failed to meet good manufacturing practices and thus would be subject to inspections by the FDA, and that, as a result of the manufacturing deficiencies, the Company’s NDA for CONTEPO was unlikely to be approved by the FDA. As a result of this information being withheld from the market, Nabriva securities traded at artificially inflated prices during the Class Period, with its stock price reaching a high of more than $3 per share.
Then on April 30, 2019, the Company revealed that it had received a Complete Response Letter (“CRL”) from the FDA for its NDA for CONTEPO. 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, or more than 27%, to close at $2.17 per share on May 1, 2019.