GIVI-MPC / IPS HEART - LARVOL DELTA

FDA Grants Orphan Drug Designation to IPS HEART’s GIVI-MPC Stem Cell Therapy for Becker Muscular Dystrophy (Businesswire) - "IPS HEART has been awarded Orphan Drug Designation (ODD) by the FDA for GIVI-MPCs based on its unique ability to create new muscle with full length dystrophin in Becker Muscular Dystrophy(BMD). IPS HEART has now shown GIVI-MPCs create new human muscle with full length human dystrophin in dystrophic pigs, young and extremely aged Duchenne Muscular Dystrophy (DMD) mice and in a sarcopenia mouse model. The FDA previously awarded GIVI-MPCs Orphan Drug Designation for DMD, highlighting the unique platform potential of GIVI-MPCs to reverse devastating diseases."

Orphan drug • Duchenne Muscular Dystrophy