11:29 AM EDT, 06/18/2024 (MT Newswires) -- BridgeBio Pharma ( BBIO ) said Tuesday it surpassed its interim analysis enrollment target for its phase 3 study of BBP-418 in people with limb-girdle muscular dystrophy type 2I/R9, with top-line results expected in 2025.
BridgeBio said there's potential to pursue accelerated approval for the drug candidate based on recent talks with the US Food and Drug Administration and its interim analysis plans.
The company also said the FDA has granted rare pediatric disease designation for BBP-418 to treat the disease.
If BBP-418 is approved, the company may now qualify for a priority review voucher after getting the rare pediatric disease designation, BridgeBio said.
Price: 26.85, Change: -0.38, Percent Change: -1.40