Akari Therapeutics' stock rockets on massive volume after 'successful' pre-IND FDA meeting
Shares of Akari Therapeutics PLC more than doubled--soaring 145%--toward a 15-month high in very active morning trade Wednesday, enough to pace all the gainers on the Nasdaq exchange, after the company said it plans to commence trials in European and U.S. pediatric patients this year for its treatment of pediatric thrombotic microangiopathy. Trading volume rocketed to 22.3 million shares, compared with the full-day average of about 20,000 shares. The company said it had a "successful," pre-investigational new drug (IND) meeting with the Food and Drug Administration regarding its pivotal clinical trial program for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA), which is an orphan condition with an estimated fatality rate of 80%. Chief Executive Clive Richardson said trials in HSCT-TMA patients are planned to begin in the fourth quarter. "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," Richardson said. The stock has now run up 93% over the past 12 months, while the iShares Nasdaq Biotechnology ETF has slipped 1.1% and the S&P 500 gained 0.9%.
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