Zogenix Plunges After FDA Refuses To Review Seizure Drug

(RTTNews) - Shares of Zogenix Inc. (ZGNX) plunged in the Monday after-hours trade, following announced that the company received a Refusal to File letter from the U.S. Food and Drug Administration regarding its New Drug Application for FINTEPLA or ZX008, fenfluramine hydrochloride for the treatment of seizures associated with Dravet syndrome.

Upon its preliminary review, the FDA determined that the NDA, submitted on February 5, 2019, was not sufficiently complete to permit a substantive review. In the letter, the FDA cited two reasons for the RTF decision: first, certain non-clinical studies were not submitted to allow assessment of the chronic administration of fenfluramine; and, second, the application contained an incorrect version of a clinical dataset, which prevented the completion of the review process that is necessary to support the filing of the NDA. The FDA has not requested or recommended additional clinical efficacy or safety studies.

The company said it will seek immediate guidance, including a Type A meeting with the FDA, to clarify and respond to the issues identified in the Refusal to File letter.

Zogenix noted that its Marketing Authorization Application for FINTEPLA for the treatment of seizures associated with Dravet syndrome was previously accepted for review by the European Medicines Agency, and the Company anticipates an approvability decision could be reached by the European Medicines Agency in the first quarter of 2020.

ZGNX closed Monday regular trading at $51.85, down $0.15 or 0.29 percent. In the after hours trade, the stock further dropped $16.35 or 31.53%.