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Akari drug gets US FDA fast-track tag for stem cell transplant complications

Akari Therapeutics PLC said the U.S. Food and Drug Administration granted fast-track designation to nomacopan to treat children facing certain complications associated with stem cell transplants.

Akari's stock price was up 32.60% to $2.40 as of 9:33 a.m. ET on Aug. 14 following the company's announcement.

The London-based pharmaceutical company is developing nomacopan to treat hematopoietic stem cell transplant associated thrombotic microangiopathy, or HSCT-TMA, which is a pattern of damage that can occur in the smallest blood vessels inside many of body's vital organs — most commonly the kidney and brain.

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Currently, there are no approved therapies for HSCT-TMA and more than 80% of children with a severe form of the disease die.

Data from an initial treatment program in HSCT-TMA patients showed a reduction in the activation of the complement system, a part of the body's immune system, and normalization of other markers associated with the disease. Patients with HSCT-TMA have high platelet count, red blood cell fragments and high blood pressure, and research supports that the complement system has a role to play.

The company plans to start a study for the drug in the fourth quarter of the year and is working with the FDA Model Informed Drug Development program to optimize the dosing of nomacopan for the trial.

The U.S. regulator grants fast-track designations to expedite the review of drugs that treat serious conditions and fill unmet medical needs. Incentives include frequent meetings and communications with the FDA and potential accelerated approval, priority review or rolling review.