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Akari Therapeutics PLC (ADR) (NASDAQ:AKTX) Explodes On FDA Validation

Akari Therapeutics PLC (ADR) (NASDAQ:AKTX)

Shares of Akari Therapeutics PLC (ADR) (NASDAQ:AKTX) jumped 56.4% after the biopharmaceutical company said it will advance its lead investigational drug Coversin on advice from the U.S. Food and Drug and Administration (FDA). The company plans to commence Phase 3 studies of the novel treatment for Paroxysmal Nocturnal Hemoglobinuria in the first quarter of 2018.

AKTX Stock Performance

Positive feedback from the FDA is one of the reasons the stock spiked higher as it shows the agency remains confident about the drug’s prospects. Thursday’s rally saw the stock close above a key support level, providing support to a bullish momentum that began last month.

Akari Therapeutics PLC (ADR) (NASDAQ:AKTX) has traded in a downtrend since reaching highs of $22 a share in April. However, AKTX shares appear to be picking up after plunging to multi-year lows of $3 a share.

Akari Therapeutics PLC (ADR) (NASDAQ:AKTX)
One month AKTX stock price chart

Coversin Prospects

Coversin has already attained Fast Track status in the U.S. – a designation that allows it to enjoy expedited regulatory review. PNH, for which the candidate drug is indicated, is a rare, life-threatening disease of the blood characterized by the destruction of red blood cells and blood clots. The condition affects 1 to 1.5 persons per million people – mostly young adults.

Phase 3 studies of Coversin will target naïve PNH patients that have not used eculizumab as a standard care. Primary endpoints will be based on hemoglobin and transfusion data

“Akari continues to build momentum in its complement focused therapy by advancing Coversin towards Phase III in PNH and Phase II in has. With Coversin delivered subcutaneously, patients may have greater independence due to self-administration,” said Dr. David Horn Solomon, Chief Executive Officer of Akari Therapeutics PLC (ADR) (NASDAQ:AKTX).

Class Action Lawsuit

Separately, Akari Therapeutics PLC (ADR) (NASDAQ:AKTX) is still the subject a class action lawsuit over claims it provided misleading statements between March 30, 2017 and May 11, 2017. According to law firm Khang & Khang LLP, former Chief Executive Officer, Dr. Gur Roshwalb, and other executives published incorrect information about the Phase 2 trial of Coversin. The law firm alleges that the company’s action resulted in the stock price losing a significant amount of value which harmed investors.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

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Monica has an undergraduate degree in Accounting and an MBA she earned - with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

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