Thinly traded nano cap Akari Therapeutics (NASDAQ:AKTX) is up 62% premarket on robust volume in reaction to the FDA’s granting of Fast Track status for Coversin (nomacopan) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) in pediatric patients.
Fast Track provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
A pivotal study should launch next quarter.
Thrombotic microangiopathy is a very serious condition where blood clots form in the smallest blood vessels that can lead to kidney failure and death.
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