Akari Therapeutics PLC (ADR) (NASDAQ: AKTX) is having an incredibly strong start to the trading session in the pre-market hours and for good reason. The company announced that it plans to advance a key pipeline treatment to Phase III clinical studies. Of course, this led to excitement among investors, causing gains in the value of the stock and prompting our partners at Trade Ideas to alert us to the movement. At the moment (8:57), AKTX is trading at $6.50 per share after a gain of 16.28% thus far today.
AKTX Gains On Regulatory Update
As mentioned above, Akari Therapeutics is having an overwhelmingly strong start to the trading session this morning after announcing that, following a recent Type B End of Phase II Meeting with the FDA, the company plans to advance CoversinTM toward Phase III clinical studies. The treatment is being studied as an option for patients with Paroxysma Noctumal Hemoglobinuria, also known as PNH. It is expected that the Phase III study surrounding the treatment will start in the first quarter of 2018.
In the FDA meeting, the FDA indicated to AKTX that providing safety and efficacy data from the company's clinical trials for the proposed number of unique PNH patients on Coversin for more than one year seems to be reasonable. Of course, this opinion is subject to review of the hard data upon submission. In a statement, Dr. David Horn Solomon, CEO at AKTX, had the following to offer:
“Following our recent FDA meeting, we are working to initiate a Phase III clinical trial of Coversin in PNH in Q1 2018... We will continue to work closely with the FDA, benefitting from our Fast Track status in the U.S., and with the EMA towards resubmission of a BLA and MMA, respectively, for Coversin in PNH.
Akari continues to build momentum in its complement focused therapy by advancing Coversin towards Phase III in PNH and Phase II in aHUS. With Coversin delivered subcutaneously, patients may have greater independence due to self-administration. Phase II studies are also planned for a number of other indications where Coversin's actions on both the complement and leukotriene (LTB4) pathways play a role. It's two leading targets in this area area atopic keratoconjunctivitis (AKC), a rare eye disorder and severe bullous pemphigoid (BP), a rare skin disorder.”
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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'll be following the ongoing work with regard to Coversin and are excited to see the results of the Phase III clinical trial. Nonetheless, we'll continue to follow the story closely and bring the news to you as it breaks!
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