Zogenix Shares Down 32% After FDA Refuses To Review Seizure Drug

(RTTNews) - Shares of Zogenix Inc. (ZGNX) plunged 32% in the extended session Monday after the company said the Food and Drug Administration did not accept a marketing application for one of its drugs.

Zogenix, a pharmaceutical company developing rare disease therapies, said it received a Refusal to File letter from FDA regarding its New Drug Application for Fintepla for the treatment of seizures associated with Dravet syndrome.

The FDA determined that the application was not sufficiently complete to permit a substantive review. 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.

"We remain highly confident in FINTEPLA's clinical profile demonstrated in the Phase 3 program in Dravet syndrome and are committed to advancing the product candidate as a potential new treatment option for this and other rare and often catastrophic epileptic encephalopathies," said Stephen J. Farr, Ph.D., President and CEO of Zogenix. "We are fully committed to working with the FDA as quickly as possible to address the open issues and clarify the path to successfully re-filing our application."

ZGNX closed Monday's trading at $51.85, down $0.15 or 0.29% on the Nasdaq. The stock further dropped $16.59 or 32% in the after-hours trade.