Celularity Announces Submission Of Request For Orphan Drug Designation For PDA-002

(RTTNews) - Celularity Inc. (CELU) has submitted a request to the FDA for orphan drug designation for off-the-shelf, placental-derived cell therapy, PDA-002, for treating Facioscapulohumeral Muscular Dystrophy. The company has already received IND clearance from the FDA and plans to begin Phase 1/2 study in 2024.

Robert Hariri, CEO, said: "We look forward to commencing our Phase 1/2 study as we continue to push forward our extensive cell therapy portfolio, including T-cells, natural killer cells, mesenchymal stem cells, and exosomes."

Celularity is a cell therapy and regenerative medicine company developing allogeneic, cryopreserved, placental-derived cell therapies.

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