AMES, Iowa, Sept. 17, 2019 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (NLNK) today announced that the U.S. Food and Drug Administration (FDA) has accepted Merck’s Biologics License Application (BLA) and granted priority review for the investigational Ebola vaccine (V920), for the prevention of disease caused by the Ebola Zaire virus. Merck’s rolling submission was made pursuant to the FDA’s Breakthrough Therapy Designation for V920, a designation awarded to our partner, Merck, in July 2016. The Prescription Drug User Fee Act (PDUFA), or target action date, is set for March 14, 2020. As NewLink has previously stated, 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) and thereafter licensed to NewLink Genetics.
“We are pleased with this morning’s announcement from our partner, Merck. The global community, Merck and government partners have worked relentlessly to further the development of the investigational V920 Ebola vaccine,” said Brad Powers, a member of the Office of the CEO. “We are thankful to those frontline responders who work tirelessly to help fight this devastating disease, and we believe this vaccine has the potential to impact many lives.”
About NewLink Genetics Corporation
NewLink Genetics is a clinical stage biopharmaceutical company focused on developing novel oncology product candidates to improve the lives of patients with cancer where treatment options are limited. NewLink Genetics' IDO pathway inhibitors, indoximod and its prodrug, NLG802, are immuno-oncology drug candidates designed to harness multiple components of the immune system to combat cancer. For more information, please visit www.NewLinkGenetics.com.
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Source: NewLink Genetics Corporation