Biohaven buys priority review voucher to expedite rimegepant Zydis ODT NDA

19 March 2019

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Biohaven Pharmaceutical (NYSE: BHVN) says it has purchased a US Food and Drug Administration priority review voucher (PRV) to use with the New Drug Application (NDA) submission of its migraine treatment candidate rimegepant ZydisODT in the second quarter of 2019.

The PRV entitles the holder to designate an NDA for priority review and provides for an expedited 6-month review. Biohaven entered into a definitive agreement to purchase the PRV for $105 million. The closing of the transaction is subject to customary conditions, including antitrust review. Biohaven’s shares closed down 1.3% at $49.44 yesterday.

The PRV was bought from GW Pharmaceuticals (Nasdaqq: GWPH), which received the voucher last year when its cannabis-based drug, Epidiolex, won US approval to treat seizures related to two rare, childhood-onset epilepsies.

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