Zogenix, Inc.’s (ZGNX) NDA Contained Inadequate Non-Clinical Data
According to the complaint for alleged violations of the Securities Exchange Act of 1934 between February 6, 2019 and April 8, 2019, In February 2019, Zogenix, Inc. announced the submission of its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for FINTEPLA. The press release touted Zogenix’s “two pivotal Phase 3 trials in Dravet syndrome and an interim analysis from an ongoing open-label extension study” on which the NDA was based. Throughout February, Zogenix executives reaffirmed positive trial results. The truth was revealed on April 8, 2019, when Zogenix issued a press release announcing it had received a Refusal to File letter from the FDA stating that the NDA was not sufficiently complete to permit a substantive review. Zogenix disclosed that it had submitted historical studies rather than conducting its own non-clinical toxicology studies. It also revealed that if the study was required, it would take Zogenix 12 to 15 months to carry out the studies. On this news, Zogenix’s stock price fell nearly 23% to close at $39.96 per share on April 9, 2019.