NewLink Genetics Corp. (NASDAQ: NLNK) shares jumped on Wednesday after the firm announced that the U.S. Food and Drug Administration (FDA) has accepted Merck & Co.’s (NYSE: MRK) 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.
Ebola is one of the white whales of the biopharma industry. There seems to be an Ebola scare every other year or so, and companies involved in Ebola vaccines take the spotlight during this crisis. In this case, NewLink and Merck are looking to get out ahead of the next crisis with this FDA approval.
Merck’s rolling submission was made according to the FDA’s Breakthrough Therapy Designation for V920. Merck received this designation in July 2016. The Prescription Drug User Fee Act (PDUFA) 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 in which NewLink Genetics has a substantial economic interest.
Consequently, NewLink would have the right to monetize its share of interest in the voucher. This Ebola vaccine candidate originally was developed by the Public Health Agency of Canada (PHAC) and thereafter licensed to NewLink Genetics.
Brad Powers, a member of the Office of the CEO, commented:
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. 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.
Shares of NewLink traded up more than 7% early Wednesday, at $2.05 in a 52-week range of $1.28 to $2.60. The consensus price target is $4.00.