Zogenix Inc. (NASDAQ: ZGNX) shares were crushed on Tuesday after the firm provided an update from the U.S. Food and Drug Administration (FDA). Unfortunately, the agency sent a Refusal to File (RTF) letter to Zogenix regarding its New Drug Application (NDA) for Fintepla for the treatment of seizures associated with Dravet syndrome, a rare and severe form of epilepsy.
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 RTF letter, the FDA cited a couple of reasons for the decision. First, certain non-clinical studies were not submitted to allow assessment of the chronic administration of fenfluramine. 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.
Previously, Zogenix’s Marketing Authorization Application for Fintepla for the treatment of seizures associated with Dravet syndrome was accepted for review by the European Medicines Agency, and the company anticipates an approvability decision could be reached by the agency in the first quarter of 2020.
Stephen J. Farr, Ph.D., president and CEO of Zogenix, commented:
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. 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.
Zogenix is seeking immediate guidance, including a Type A meeting with the FDA, to clarify and respond to the issues identified in the RTF letter.
Shares of Zogenix were last seen down over 24% at $39.15, in a 52-week range of $33.43 to $62.75. The consensus price target is $71.45.