NewLink Genetics NLNK Stock News

NewLink Genetics Corp (NASDAQ: NLNK) is making a run for the top in the market this morning, trading on gains of more than 7%. The gains come after the comapny said that the FDA has accepted a Biologics License Application (BLA). Here’s what’s going on:

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NLNK Stock Climbs On BLA Acceptance

NewLink Genetics issued a press release early this morning, announcing that the FDA has accepted ia BLA filed by Merck (MRK). The BLA has been granted priority review, surrounding an investigational Ebola vaccine for the prevention of disease caused by the Ebola Zaire virus.

So, what does this have to do with NLNK? Well, the company partnered with MRK back in July of 2016 for the development of this vaccine. So, should MRK receive an approval, NLNK investors will have something to be very happy about.

Importantly, the PDUFA date has been set for March 14, 2020. This is the date when the FDA will make the decision whether or not to approve the vaccine. If the FDA does approve the vaccine, it will trigger the issuance of a priority review voucher owned by Merck but with substantial economic interest to NewLink.

In fact, upon approval, the company will have the right to monitize its share of interest int he voucher. In a statement, Brad Powers, member of the Office of the CEO, had the following to offer:

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.

Why This Is Such A Big Deal!

Ebola is a very big topic of discussion these days, striking fear into many. Importantly, as of right now, there are no FDA approved vaccines for the ailment, leaving consumers with no feasible option to prevent contracting the virus.

Should the FDA approve the Ebola vaccine, it will be the first to hit the market. So, what’s the demand like?

While Ebola isn’t a big issue in the United States as of yet, those traveling abroad will see big benefits in getting vaccinated. Moreover, if the FDA were to approve the vaccine, it will add validity, likely leading to stronger use around the world.

All in all, this is a massive untapped market, and while MRK is the holder of the drug, NLNK has a very large economic interest. As such, this could be a game changer for the company!

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