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Zogenix gets refusal-to-file letter for Dravet syndrome therapy

April 8, 2019 11:17 PM UTC

Zogenix was off $16.11 (31%) to $35.74 in early after-hours trading Monday after the company said FDA issued a refusal-to-file letter for an NDA for Fintepla (ZX008) to treat seizures associated with Dravet syndrome.

Fintepla is an oral solution of low-dose fenfluramine, a derivative of amphetamine that promotes the release of serotonin (5-HT) from neuronal storage vesicles and inhibits its reuptake...

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