Minovia Therapeutics Receives FDA Orphan Drug Designation for MNV-201 in Myelodysplastic Syndrome
Launch One Acquisition Corp. - Class A Ordinary Shares (LPAA)
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Source: GlobeNewswire
HAIFA, Israel, Oct. 15, 2025 (GLOBE NEWSWIRE) -- Minovia Therapeutics Ltd. (“Minovia” or the “Company”), a clinical-stage biotechnology company developing novel therapies to treat mitochondrial diseases and combat age-related decline, announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) 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 Designation in MDS, as well as both Fast Track and Rare Pediatric Disease Designations for MNV-201 in the treatment of Pearson Syndrome. “We continue to receive validation from the FDA for the potential of our lead product, MNV-201, this time in the form of Orphan Drug Designation in MDS. MNV-201 targets the mitochondria, a critical multi-functional organelle. FDA designations such as ODD underscore the urgency of drugs treating these diseases affecting sm
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- Minovia Therapeutics Mitochondrial Augmentation Technology to be Featured in Presentation and Workshop at the 67th ASH Annual Meeting and ExpositionGlobeNewswire
- Minovia Therapeutics Mitochondrial Augmentation Technology to be Featured in Presentation and Workshop at the 67th ASH Annual Meeting and ExpositionGlobeNewswire
- Minovia Therapeutics Receives FDA Orphan Drug Designation for MNV-201 in Myelodysplastic SyndromeGlobeNewswire
- Minovia Therapeutics Receives FDA Fast Track Designation for MNV-201 in Myelodysplastic SyndromeGlobeNewswire
- Minovia Therapeutics Receives FDA Fast Track Designation for MNV-201 in Myelodysplastic SyndromeGlobeNewswire