NewLink Genetics Announces FDA Approval of Ebola Vaccine V920 (ERVEBO®)
NEWLINK GENETICS (NLNK)
Last newlink genetics earnings: 2/28 09:00 am
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Source: GlobeNewswire
AMES, Iowa, Dec. 20, 2019 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (NASDAQ:NLNK) announced today that, after priority review, the FDA has granted approval of ERVEBO®, or Zaire Ebola virus vaccine V920 (rVSV?G-ZEBOV-GP), as confirmed by our partner, Merck (NYSE:MRK), known as MSD outside the US and Canada. This represents the first vaccine approved by the FDA for the Ebola virus and follows the November 11th grant by the European Commission (EC) of a marketing authorization for ERVEBO® across 31 European countries. Yesterday’s approval comes almost three months prior to the Prescription Drug User Fee Act (PDUFA), or target FDA action date, originally set for March 14, 2020. As NewLink has previously stated, the FDA’s approval of this Ebola vaccine will trigger the issuance of a priority review voucher (PRV) owned by Merck and in which NewLink Genetics has a substantial economic interest. Thereafter, NewLink will have the right to monetize its share of interest in the vouche
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