It’s not easy to get approval from the FDA. There are steps to follow, standards to meet. Sometimes, companies fail. But Akari Therapeutics (NASDAQ:AKTX) is not one of them, receiving Fast Track approval from the federal agency this week. On the news, AKTX stock jumped, currently up nearly 40%.
AKTX Stock Skyrockets 30% on FDA Fast Track Designation
Today, August 14, United Kingdom-based Akari Therapeutics announced it has been given a “Fast Track” designation by the United States FDA for its treatment of stem-cell transplant-associated thrombotic microangiopathy in pediatric patients. Of course, any approval from the FDA is significant, but a Fast Track designation is a whole other story. Essentially what this designation means is that companies with this designation have more help when developing and expediting the review of new drugs for treating life-threatening or serious conditions.
Speaking on the news, CEO Clive Richardson said the following: “Fast Track designation provides our HSCT-TMA clinical program a pathway for an expedited approval for nomacopan, and we plan to commence a pivotal trial in the fourth quarter of 2019.”
Considering AKTX stock has fallen more than 40% over the past three months, today’s trading results will be embraced by investors worldwide. In pre-market trade, AKTX stock jumped more than 60%. A few hours later, AKTX stock has dropped a bit but is still trading at an impressive level. As of 11:33 AM EDT, Akari stock is trading at $2.41, which puts it up 33%.
What Does the Future Hold?
Akari Therapeutics is clearly doing something right to get a Fast Track designation from the US FDA. It’s not every day this happens. And if all continues to go well, we might see AKTX stock trading like this in the coming weeks.
What do you think? Can AKTX stock continue to climb for the rest of the day? Let us know in the comments below.
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