The thinly traded, nano-cap biotech Akari Therapeutics PLC AKTX gap-opened higher Wednesday morning, and shares were advancing strongly on above-average volume.
What Happened
Akari, which focuses on developing therapies for orphan autoimmune and inflammatory diseases, said Wednesday the FDA has granted its nomacopan Fast Track designation for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy, or HSCT-TMA, in pediatric patients.
Why It's Important
HSCT-TMA is an orphan condition with no approved therapy and and an estimated fatality rate of 80%.
The Fast Track designation is issued to facilitate the development and expedite the review of new drugs that show promise in treating serious life-threatening conditions and address unmet medical needs.
The status vests advantages such as frequent communication and meetings with the FDA to review the developmental plan for the drug, including the design of proposed clinical trials, use of biomarkers and the extent of data needed for approval.
If relevant criteria are met, a drug with a Fast Track designation qualifies for a priority review, which reduces the review period from the standard 12 months to six months.
The pivotal trial that could support a regulatory filing is set to commence in the fourth quarter of 2019.
Akari shares were trading higher by 34.25% at $2.43 at the time of publication Wednesday on about 150 times their average volume.
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