- The FDA has granted Fast Track Designation to BridgeBio Pharma Inc’s (NASDAQ: BBIO) BBP-418 as a treatment option for Limb-girdle Muscular Dystrophy Type 2i (LGMD2i).
- This is the fifth Fast Track designation for an investigational therapy that BridgeBio has received this year.
- Clinical trials to verify the safety and efficacy of BBP-418 are ongoing.
- BBP-418 has received Orphan Drug Designation for the treatment of LGMD2i from the FDA and LGMD from the European Medicines Agency.
- LGMD2i is a monogenic autosomal recessive disease caused by partial loss of function mutations in the FKRP gene. These FKRP mutations impair glycosylation of α-DG, a protein associated with stabilizing muscle cells.
- Related Link: FDA Approves BridgeBio Pharma’s FGFR2 Inhibitor for Bile Duct Cancer.
- Related content: Benzinga’s Full FDA Calendar.
- Price Action: BBIO shares are up 2.61% at $50.00 during the premarket session on the last check Wednesday.
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