BridgeBio Pharma's Candidate For Muscle-Wasting Disorder Wins Fast Track Tag In US

The FDA has granted Fast Track Designation to BridgeBio Pharma Inc's 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.