05:20 PM EDT, 09/10/2024 (MT Newswires) -- BridgeBio Pharma ( BBIO ) said late Tuesday that the US Food and Drug Administration has granted the regenerative medicine advanced therapy designation to BBP-812, an investigational intravenous gene therapy to treat Canavan disease.

The move follows an FDA review of data from a phase 1/2 clinical study of the fatal neurodevelopmental disorder, the company said.

BridgeBio said it plans to "leverage" the benefits of the designation, including early and more frequent interactions with the FDA, to establish an "accelerated approval" pathway.

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