Akari Therapeutics announced that the European Commission granted orphan drug designation, ODD, to nomacopan as a treatment in hematopoietic stem cell transplantation following the European Medicines Agency positive opinion in June. Akari is currently conducting a registrational Phase 3 study of nomacopan in pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy, HSCT-TMA. Additionally, the company is moving forward into a Phase 3 double-blind placebo-controlled clinical trial of nomacopan in adult HSCT-TMA with enrollment expected to begin in 2024.
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