The First Ebola Vaccine Has Been Approved in the US

Health and Healthcare

Published: December 20, 2019 11:45 am

Last Updated: January 30, 2020 11:55 am

NewLink Genetics Corp. (NASDAQ: NLNK) and Merck & Co. Inc. (NYSE: MRK) shares made handy gains on Friday after it was announced that the U.S. Food and Drug Administration (FDA) has granted approval to Ervebo, the Zaire Ebola virus vaccine V920.

The approval comes almost three months prior to the Prescription Drug User Fee Act (PDUFA) target FDA action date, originally set for March 14, 2020.

Overall, this represents the first vaccine approved by the FDA for the Ebola virus and follows the November 11 grant by the European Commission of a marketing authorization for Ervebo across 31 European countries.

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. NewLink will have the right to monetize its share of interest in the voucher.

Eugene Kennedy, M.D., chief medical officer and member of NewLink Genetics’ Office of the CEO, commented:

We are delighted by the FDA’s decision to approve this Ebola vaccine and by the agency’s recognition of the potential this vaccine may offer to protect individuals who may be exposed to Ebola from contracting this deadly disease. We are grateful to our partner Merck, and to the regulatory bodies involved, for their dedication to advancing solutions to combat this deadly illness.

Shares of Merck were last seen up about 1.6%, at $91.46 in a 52-week range of $70.89 to $92.63. The consensus price target is $97.94.

NewLink Genetics shares were up about 14% to $1.83. The 52-week range is $1.13 to $2.27, and the consensus price target is $4.00.

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