Jazz (JAZZ) Submits NDA For Xyrem Follow-On Candidate JZP-258 (Revised)
Zacks Investment Research | Jan 28, 2020 02:59AM ET
Jazz Pharmaceuticals plc (NASDAQ:JAZZ) announced that it has submitted a new drug application (“NDA”), seeking approval for JZP-258 as a treatment for cataplexy and excessive daytime sleepiness (“EDS”) associated with narcolepsy in patients seven years or older.
The company has redeemed a priority review voucher for the NDA submission, which may lead to accelerated review of the regulatory application.
JZP-258 is a follow-on candidate of the company’s blockbuster sleep disorder drug, Xyrem. It is an oxybate product candidate with 92% less sodium content than Xyrem, which is also approved for cataplexy or EDS sleepiness associated with narcolepsy.
Jazz’s shares have increased 15.5% in the past year compared with the Zacks Investment Research
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