The FDA has granted orphan drug designation to Akari Therapeutics’ (NASDAQ:AKTX) nomacopan for the treatment of hematopoietic stem cell transplantation-associated thrombotic microangiopathy (HSCT-TMA).
A pivotal trial is expected to start in Q4 2019.
Among the benefits of Orphan Drug status in the U.S. is a seven-year period of market exclusivity for the indication, if approved.
Shares were up 15% premarket.
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