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- BridgeBio (NASDAQ:BBIO) has received FDA Regenerative Medicine Advanced Therapy designation for its AAV9 gene therapy candidate BBP-812 for the treatment of patients with Canavan disease, a fatal neurodegenerative disorder.
- The company said it plans to leverage the benefits of the designation to establish an accelerated pathway for the treatment, according to a statement.
- The therapy has also been granted Orphan Drug, Rare Pediatric Disease, and Fast Track Designations by the FDA, as well as Orphan Drug Designation by the European Medicines Agency.
