Zogenix plans quick return to the FDA with their spurned application on Dravet syndrome drug — shares spike
Zogenix shares are clawing back some of the value they lost 2 months ago after the FDA hit the biotech with a refuse-to-file notice on their experimental therapy for Dravet syndrome.
Company execs said this morning that they worked out regulators’ issues with the application for Fintepla, which centered on a pair of big problems: the absence of non-clinical studies needed to allow assessment of the chronic administration of fenfluramine and the inclusion of an incorrect version of a clinical dataset. Now they plan to resubmit in Q3 after getting off the hook on both scores — which triggered a sigh of relief among investors.
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