Akari Therapeutics PLC (ADR) (NASDAQ:AKTX) Is A Big Gainer With More To Come

Akari Therapeutics PLC (ADR)(NASDAQ:AKTX) became one of the most assessed stocks this week after the company released that it is planning to advance its lead investigational drug, Coversin, towards the commencement of Phase III clinical studies in Paroxysmal Nocturnal Hemoglobinuria (PNH) in Q1 2018. AKARI LogoDid the market push up the share price?Yes, the share price reaction was astonishing. In only one session, the share price went from trading below $6.00 to touch the level of $11.00. That's not all. The volume, which is one of the best indicators of market interest, was incredible as well; more than 10 million shares changed hands. Have a look at it: 1 year chart for AKTX 1 month chart for AKTXWe don't want to say 'we said that something like this would happen', but we need to recall our article published on September 14, 2017. We noted that a new CEO had been elected, the financial statements of the company looked very solid and the company had given stock options to purchase ordinary shares to the CEO and other officers. This is exactly what we said:

"We found many facts that we appreciate in this name that make us believe that something good may be announced soon. The fact that the CEO was recently changed is certainly positive. He has experience of leading Phase 2-stage companies and may be helping the company speed up the FDA approval process. Additionally, insiders and other market participants hold large stakes in the company and they don’t seem to be willing to sell." Source

Also, at the end, we added "To sum up, be alert on this company, it may announce something soon." What were the returns?We published our piece on Sunday, September 17, 2017. The share price was $5.46 on the following Monday, while as of today, September 22, 2017, it is $8.50, but it went up to $11 on the day of announcement.Recent DevelopmentsLet's revisit the company's background. Akari was founded in 2004 and is headquartered in London, U.K. The company is focused "on inhibitors of early mediators of acute and chronic inflammation, specifically the complement system, the eicosanoid system and the bioamine system." The flagship drug of AKTX is Coversin, which we will cover in this article. But, the company has other candidates in Phase 1 and in preclinical phase, which we should not forget. In "akaritx.com/other-molecules", we could find the following information about them:

"Akari has an ongoing discovery and early development program involving several additional tick-derived anti-inflammatory proteins. This pipeline includes a range of new and engineered proteins, including compounds only binding LTB4, histamine, serotonin and tissue targeting compounds, including an engineered version of Coversin designed to target the neuromuscular junction (NMJ)." Source

Let's focus on Coversin.What are the diseases targeted and when will the company expect the trials?On akaritx.com, we found the following about the diseases: Diseases targeted by CoversinSo, what are the news now?On September 21, 2017, the company noted that "following the advance of the FDA", it will continue the R&D work on Coversin to try to pass the Phase III clinical studies in Paroxysmal Nocturnal Hemoglobinuria (PNH) in Q1 2018. Following were, in our opinion, the most significant words of Dr. David Horn Solomon, Chief Executive Officer of Akari Therapeutics:

“We will continue to work closely with the FDA, benefitting from our Fast Track status in the U.S., and with the EMA towards submission of a BLA and MAA, respectively, for Coversin in PNH.” Source

Furthermore, the FDA mentioned that the fact that the company provides safety and efficacy data in the trials "for the proposed number of unique PNH patients on Coversin for more than one year seems reasonable." The information is quite relevant for us, since the company is telling when the new data may be reviewed. We want to highlight it for those who are new to this type of processes; this could be a catalyst for the stock.Readers interested in PNH can get to know more here. For those who have no time to spend, we will say that it is a rare and acquired disease of the blood that destroys red blood cells by the complement system, a part of the body's innate immune system.What are the insiders doing ?We did not identify any sales disclosed by directors.NameSharesDate ReportedRPC PHARMA LTD722,345,600Sep 17, 2015COHEN MARK S1,055,600Sep 17, 2015SourceAdditionally, we did not see funds selling stock yet:HolderSharesDate Reported% OutValueDeerfield Management818,158Jun 29, 20176.95%4,098,971Vivo Capital, LLC527,842Jun 29, 20174.48%2,644,488Baker Brothers Advisors, LLC496,901Jun 29, 20174.22%2,489,474NEA Management Company, LLC452,167Jun 29, 20173.84%2,265,356VHCP Management II, LLC426,297Jun 29, 20173.62%2,135,748SourceConclusionCurrently trading with a market cap of $102 million, AKTX is an exciting story among small caps. We continue to see insiders and major funds holding maintaining their positions. The company showed $31 million in cash, and only 9 million in total liabilities. For investors, more catalysts lie ahead, especially the data the Phase III trial. If the data is positive, the AKTX bull run is in its early innings.Be sure to check out our coverage on AKTX!We will be updating our subscribers as soon as we know more. For the latest updates on AKTX, sign up below!Image courtesy of HCC Public Information Office via FlickrDisclosure: We have no position in AKTX and have not been compensated for this article.