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ZGNX

Zogenix

$26.04 /

-1.96 (-7.00%)

08:06
02/27/20
02/27
08:06
02/27/20
08:06

Zogenix announces FDA extension of review period for FINTEPLA

Zogenix announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application for FINTEPLA for the treatment of seizures associated with Dravet syndrome. The new Prescription Drug User Fee Act target action date has been extended by three months to June 25, 2020. The extension allows the FDA time to review additional data submitted by Zogenix in response to a recent information request from the FDA. The FDA determined that the submission of this information constituted a major amendment to the NDA, resulting in this extension of the PDUFA goal date by three months. The NDA for FINTEPLA was originally accepted for filing in November 2019 under the FDA's Priority Review program with a six-month review period, and is based on data from two positive pivotal Phase 3 trials in Dravet syndrome and an interim analysis from an ongoing open-label extension study, which included 232 patients treated for up to 21 months.

  • 02

    Mar

  • 25

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ZGNX Zogenix
$26.04 /

-1.96 (-7.00%)

02/10/20 Mizuho
Mizuho ups Zogenix target to $71 on likely approval in Lennox Gastaut syndrome
02/07/20 Empire
Empire says $66 price target for Zogenix based on Fintepla approval for Dravet
02/07/20 Guggenheim
Guggenheim still sees Zogenix's Fintepla approval despite 'underwhelming' data
02/07/20 Ladenburg
Zogenix downgraded to Neutral from Buy at Ladenburg

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