NewLink Genetics Announces Merck Has Begun Rolling Submission of Licensure Application for Ebola vaccine V920 (rVSV?G-ZEBOV-GP) to U.S. Food and Drug Administration
NEWLINK GENETICS (NLNK)
Last newlink genetics earnings: 2/28 09:00 am
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Source: GlobeNewswire
In 2014 the Company entered into a license agreement with Merck to develop, manufacture and commercialize NewLink Genetics’ Ebola vaccine candidate AMES, Iowa, Nov. 15, 2018 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (NASDAQ:NLNK) reported today that Merck has begun the submission of a rolling Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for V920 (rVSV?G-ZEBOV-GP, live attenuated). This rolling submission is made pursuant to the FDA’s Breakthrough Therapy Designation for V920, which was announced by Merck in July 2016 and is anticipated to be completed in 2019. The FDA’s approval of this Ebola vaccine would trigger the issuance of a priority review voucher owned by Merck and in which NewLink Genetics has a substantial economic interest. Thereafter, NewLink would have the right to monetize its share of interest in the voucher. This Ebola vaccine candidate was originally developed by the Public Health Agency of Canada (PHAC
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