Core Insights - The U.S. FDA has granted Orphan Drug Designation (ODD) to Minovia Therapeutics' lead investigational compound, MNV-201, for Myelodysplastic Syndrome (MDS), adding to its existing Fast Track Designation [1][2] - MNV-201 is a first-in-class mitochondrial cell therapy aimed at treating mitochondrial diseases and age-related decline, with a focus on improving outcomes for MDS patients [3][7] - Minovia has entered into a definitive business combination agreement with Launch One Acquisition Corp., with the transaction expected to close in late 2025, leading to a new Nasdaq listing [5] Company Overview - Minovia Therapeutics is a clinical-stage biotechnology company based in Haifa, Israel, focused on developing therapies to replace defective mitochondria and combat aging [8][9] - The company is currently conducting a Phase Ib study of MNV-201 in low-risk MDS patients, with six out of nine expected patients already dosed [6] Product Details - MNV-201 utilizes Minovia's proprietary Mitochondrial Augmentation Technology (MAT) to enhance patients' stem cells with healthy mitochondria, aiming to restore organ function [7] - Early-stage clinical studies of MNV-201 have shown a strong safety profile and potential multi-system benefits for patients with Pearson Syndrome [7]