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.
Zogenix stock climbed 27% before the opening bell Thursday on hopes of a near-term second turn at bat. The biotech noted:
Based on the final meeting minutes received, the FDA has agreed to Zogenix’s plan to resubmit the NDA for Fintepla without the inclusion of the new chronic toxicity studies requested in the RTF letter. With regards to the second issue, the company conducted and discussed with the FDA a root cause analysis to explain the incorrect clinical dataset submitted in the original NDA, and the FDA is in agreement with the company’s plan for resubmission of the datasets in the NDA.
This time around, though, Zogenix’s team will not have the benefit of a breakthrough therapy designation to boast about. With 2 drugs on the market, the FDA no longer felt that their drug qualified. But the company is still holding out hopes for a priority review.
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