We are investigating Nabriva Therapeutic plc (NBRV) (“Nabriva” or the “Company”) for potential violations of the federal securities laws.
On April 30, 2019, Nabriva disclosed receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) for the Company’s New Drug Application (“NDA”) seeking marketing approval of CONTEPO™ (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis. Nabriva advised investors that “[t]he CRL requests that Nabriva address issues related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers prior to the FDA approving the NDA.” On this news, Nabriva’s stock price fell $0.82 per share, or 27.42%, to close at $2.17 per share on May 1, 2019.