Celularity submits request to FDA for orphan drug designation for PDA-002

Celularity submitted a request to the U.S. Food and Drug Administration for orphan drug designation for its off-the-shelf, placental-derived cell therapy, PDA-002, for treating Facioscapulohumeral Muscular Dystrophy. Earlier, Celularity received FDA Investigational New Drug Application clearance for PDA-002 in FSHD and plans to commence a phase 1/2 study in the second half of 2024. The trial serves as an important component for submitting a Biologics License Application to the FDA in the future as a potential treatment for FSHD and other types of muscular dystrophy.