NewLink Genetics Receives FDA Acceptance for Partnered Biologics License Application

- September 18th, 2019

NewLink Genetics (NASDAQ:NLNK) has announced that the US Food and Drug Administration has accepted Merck’s (NYSE:MRK)’s Biologics License Application and designated priority review for the investigational Ebola vaccine (V920). As quoted in the press release: Merck’s rolling submission was made pursuant to the FDA’s Breakthrough Therapy Designation for V920, a designation awarded to our partner, … Continued

NewLink Genetics (NASDAQ:NLNK) has announced that the US Food and Drug Administration has accepted Merck’s (NYSE:MRK)’s Biologics License Application and designated priority review for the investigational Ebola vaccine (V920).

As quoted in the press release:

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.”

Click here to read the full press release.

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