MedPath

BBP-812

Generic Name
BBP-812
Brand Names
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Drug Type
Biotech
Chemical Formula
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CAS Number
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Unique Ingredient Identifier
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Associated Conditions
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Associated Therapies
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biospace.com
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BridgeBio Receives FDA's Regenerative Medicine Advanced Therapy (RMAT) Designation

FDA grants RMAT designation to BridgeBio's BBP-812 gene therapy for Canavan disease, based on CANaspire trial data showing functional improvements in all dosed patients.
morningstar.com
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BridgeBio Pharma Gets FDA Regenerative Medicine Advanced Therapy Designation

BridgeBio Pharma's Canavan disease treatment BBP-812 granted regenerative medicine advanced therapy designation by FDA, based on CANaspire Phase 1/2 clinical trial data. The treatment has also received orphan drug, rare pediatric disease, and fast track designations from the FDA and Orphan Drug Designation from the European Medicines Agency.
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