Israeli biotechnology company Minovia Therapeutics Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to the Company's lead investigational compound, MNV-201 for Myelodysplastic Syndrome (MDS), a serious age-related hematopoietic disease.
This designation is in addition to the existing FDA Fast Track and Rare Pediatric Disease Designations for MNV-201 in the treatment of Pearson Syndrome, which is under Phase 2 clinical trial.
The designation provides Minovia with the opportunity for increased FDA interactions, potential eligibility for priority review, and the opportunity for a rolling submission of a future Biologics License Application (BLA) for MNV-201.