NewLink Genetics Corp NLNK shares are poised to break above the $2 psychological barrier for the first time since early April after the company issued a regulatory update on a partnered program.
The FDA has accepted partner Merck & Co., Inc. MRK's BLA for its investigational Ebola vaccine, according the application priority review status, NewLink said Tuesday.
The PDUFA goal date has been set for March 14, 2020.
Potential approval of the vaccine will trigger issuance of a priority review voucher owned by Merck and in which NewLink has a substantial economic interest.
The priority review voucher program was created by the U.S. Congress in 2007, and under the program, on approval of a treatment for a neglected or rare pediatric disease, the developer will be issued a voucher for priority review for a different drug as a means of incentivizing development of treatments for neglected and rare diseases.
"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 NewLink exec Brad Powers.
NewLink can then monetize its share of interest in the voucher.
The vaccine candidate, originally developed by the Public Health Agency of Canada, was licensed to NewLink.
NewLink shares were up 4.71% at the time of publication, while Merck shares were 0.32% higher.
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