Posted by Michael Wonder on 18 Sep 2025
Minovia Therapeutics receives FDA fast track designation for MNV-201 in myelodysplastic syndrome
18 September 2025 - Minovia Therapeutics announces that the US FDA has granted fast track designation to the Company’s lead investigational compound, MNV-201 for myelodysplastic syndrome, a serious age-related haematopoietic disease.
This designation is in addition to the existing FDA fast track and rare paediatric disease designations for MNV-201 in the treatment of Pearson syndrome, an ultra rare and life-threatening mitochondrial disorder affecting children and for which the Company is currently conducting a Phase 2 clinical trial.
