Newlink Genetics is getting a boost with a 13% pre-market jump based on FDA acceptance of the company’s application for an Ebola vaccine called V920.
The move up some $0.10 from the previous close caps a rally where NLNK moved from $1.65 September 9 to current values near $2.00.
Plan documents show Newlink is partnering with Merck & Company on the investigational drug with a PDUFA date set for March 14 of next year.
“We are pleased with this morning’s announcement from our partner, Merck,” said NewLink exec Brad Powers in a press statement. “The global community, Merck and government partners have worked relentlessly to further the development of the investigational V920 Ebola vaccine.”
Under a program created by the U.S. Congress in 2007, a developer gets a voucher for priority review in order to incentivize development of disease-based cures.
“FDA’s priority review voucher (PRV) programs are about drug development, and specifically the time and cost of drug development and the conditions a new drug is intended to treat,” write Alexander Gaffney, Michael Mezher and Zachary Brennan by way of explanation at Regulatory Focus. “Developing a new drug is a costly and time-intensive affair. … In 2014, US legislators made a major change to the tropical disease priority review voucher program with the intent of providing additional incentives to fight the Ebola virus and several other related viruses.”
At the start of the week, Merck equity rested near $82 after cresting at $83.47 Tuesday morning.
As for Newlink Genetics, chart history shows a 52-week high of $2.60 and a 52-week low of $1.28 with a value of $2.14 in March.
