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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 (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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