Zogenix Inc (NASDAQ:ZGNX) is reeling after the Food and Drug Administration late Thursday refused to review the company’s new drug application for Fintepla, a treatment for seizures associated with Dravet syndrome.
In a refusal-to-file letter, the FDA pointed to an incorrect version of a dataset in the Emeryville, California company’s application and the exclusion of certain non-clinical studies, which prevented the administration from completing a review.
The drugmaker is seeking a Type A – high priority – meeting with the FDA to address the concerns.
“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,” President and CEO Stephen J. Farr said. “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.”
Shares plummeted more than 22% to $40.22.
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