Scholar Rock says FDA grants fast track status for apitegromab in FSHD

PUBT · 4d ago
Scholar Rock says FDA grants fast track status for apitegromab in FSHD
  • FDA granted Fast Track designation for apitegromab in facioscapulohumeral muscular dystrophy, adding to Orphan Drug status for the program.
  • Participant dosing started in the Phase 2 FORGE trial, testing 10 mg/kg intravenous apitegromab every four weeks for 52 weeks.


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