Akari Therapeutics PLC (NASDAQ: AKTX) is rocketing in the market this morning, and for good reason. The company announced a regulatory update that excited investors who are sending the stock screaming for the top. Today, we’ll talk about:
- The regulatory update;
- what we’re seeing from AKTX stock as a result; and
- what we’ll be watching for ahead.
AKTX Announces Regulatory News
As mentioned above, Akari Therapeutics is rocketing in the market this morning after announcing a regulatory update. In the press release issued early this morning, the company released the results of a pre-IND meeting with the United States Food and Drug Administration.
In the release, the company said that the Type B meeting was a success. The meeting surrounded the company’s proposed pivotal clinical trial program for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA).
AKTX reminded investors that HSCT-TMA is an orphan condition with an estimated fatality rate of more than 80% in children with the disease. According to the release, the FDA and the company agreed upon a trial design.
The primary endpoint of the pivotal trial will be response to Coversin of selected, clinically meaningful treatment variables. The company said that the responder endpoints were based on work done by Sonata Jodele, M.D., a world-leading expert in the treatment of pediatric HSCT-TMA.
In a statement, Clive Richardson, interim CEO at AKTX, had the following to offer:
Akari plans to commence a trial in European and U.S. pediatric HSCT-TMA patients in the fourth quarter of 2019. We see HSCT-TMA as a gateway indication into a range of other poorly treated orphan TMAs, and are enthusiastic about the potential of Coversin to offer an improved standard of care for patients with these rare and usually fatal conditions.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news leads to moves. When it comes to Akari Therapeutics, the news proved to be overwhelmingly positive.
With the positive meeting in mind, we can expect that an IND will be submitted and that a pivotal clinical trial will be initiated relatively soon. This brings the company one step closer to bringing its treatment for this devastating condition to market.
Considering this, it’s not surprising to see that excited investors are sending the stock on gains in multiples. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (10:47), AKTX is trading at $4.72 per share after a gain of $2.90 per share or 159.34% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on AKTX. In particular, we’re interested in following the story surrounding the company’s continued work to bring Coversin to market. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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