Avidity Biosciences Inc. has announced that the U.S. FDA has opened the accelerated approval regulatory pathway for their drug del-brax, targeting facioscapulohumeral muscular dystrophy (FSHD). This development paves the way for a planned accelerated approval Biologics License Application $(BLA.AU)$ submission in the second half of 2026, following topline data from the FORTITUDE™ biomarker cohort in the second quarter of 2026. Additionally, Avidity has initiated the global, confirmatory Phase 3 FORWARD™ study, involving approximately 200 participants across North America, Europe, and Japan. This study aims to evaluate the efficacy of del-brax in improving functional mobility and strength in individuals with FSHD. The initiation of this study marks a critical step in Avidity's strategy to secure global approval for del-brax.
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