Akari Therapeutics PLC (NASDAQ: AKTX) is having a great start to the trading session this morning, following up on the strong gains that we saw on the stock yesterday. The gains come after the comapny announced regulatory news, setting the stage for a pivotal clinical trial. Today, we’ll talk about:
- The regulatory news that started the run;
- what we’re seeing from AKTX stock as a result; and
- what we’ll be watching for ahead.
AKTX Continues Climbing On Regulatory Update
As mentioned above, Akari Therapeutics is having a great day in the market today, following up on the gains in multiples that we saw yesterday. The gains came after the company announced the results of a meeting with the United States Food and Drug Administration.
The news came yesterday via press release. In the release, AKTX announced that it had a successful Type B, pre-IND meeting with the FDA. The meeting surrounding the company’s proposed pivotal clinical trial program for HSCT-TMA.
HSCT-TMA is an orphan condition. Unfortunately, it is estimated that more than 80% of children with this severe disease will die from it.
In the release, AKTX said that the framework for the trial was agreed to with the FDA. Should all go well in the trial, the company’s Coversin product will be ready for a New Drug Application with the FDA.
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
As investors, one of the first lessons that we learn is that the news moves the market. When it comes to Akari Therapeutics, the news proved to be overwhelmingly positive.
After all, should the trial go well, the company will be headed for commercial approval. As you could imagine, the news excited investors, sending the stock on a run for the top.
As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:38), AKTX is trading at $8.57 per share after a gain of $2.67 per share or 45.25% 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 keep a close eye on the news and bring it to you as it breaks!
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