Celularity Submits Request to U.S. FDA for Orphan Drug Designation for PDA-002 Asset Treating Facioscapulohumeral Muscular Dystrophy
Celularity Inc. - Class A (CELU)
Company Research
Source: GlobeNewswire
FLORHAM PARK, N.J., March 20, 2024 (GLOBE NEWSWIRE) -- Celularity Inc. (NASDAQ: CELU) (“Celularity”), a regenerative medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, announced today that it has submitted a request to the U.S. Food and Drug Administration (FDA) for orphan drug designation for its off-the-shelf, placental-derived cell therapy, PDA-002, for treating Facioscapulohumeral Muscular Dystrophy (FSHD). Orphan drug designation is a status given to drugs that show the potential to treat, prevent or diagnose serious or life-threatening diseases that affect fewer than 200,000 people in the U.S. 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 (BLA) to the FDA in the future as a potential treatment for FSHD and other
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- Celularity Inc. Announces Receipt of Nasdaq Notice Regarding Late Form 10-K FilingGlobeNewswire
- Celularity Abstract “Emerging Technologies for the Management and Protection of Tendon Injuries: Decellularized Placental Biomaterials” Accepted at ORS Tendon Conference 2024 [Yahoo! Finance]Yahoo! Finance
CELU
Earnings
- 1/2/24 - Miss
CELU
Sec Filings
- 4/22/24 - Form 8-K
- 4/16/24 - Form 4
- 4/16/24 - Form 4
- CELU's page on the SEC website