Akari Therapeutics Announces Pivotal Phase III Trial Design of Nomacopan in Pediatric Hematopoietic Stem Cell Transplant-Related Thrombotic Microangiopathy (HSCT-TMA), Following FDA Meetin...
US:NASDAQ Investor Relations: investor.akaritx.com/investor-relations
Update on Paroxysmal Nocturnal Hemoglobinuria (PNH) Long Term Safety Study Shows 100% Transfusion Independence Two-part pivotal Phase III study of nomacopan in pediatric patients with HSCT-TMA based on guidance from End-of-Phase II meeting with U.S. Food and Drug Administration (FDA): Part A dose confirmation study. Dosing scheme has been agreed with the FDA through Akari’s participation in the Model Informed Drug Development (MIDD) Program.Part B single arm responder-based efficacy study will follow an interim analysis of Part A and a meeting with the FDA. Phase III HSCT-TMA study expected to open by the end of Q4 2019.HSCT-TMA program has received both orphan and Fast Track designations from the FDA.New data from ongoing long-term PNH study shows that all six patients from the Phase II study who were transfusion dependent at entry are now transfusion independent on nomacopan. NEW YORK and LONDON, Dec. 02, 2019 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a biopha
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AKTX
SEC Filings
- 12/2/19 - Form 6-K
- 11/27/19 - Form 6-K
- 11/27/19 - Form 6-K
- AKTX's page on the SEC website
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