Avidity Biosciences Secures Accelerated Approval Pathway for Del-Brax in the U.S. and Launches Global Phase 3 Study for FSHD Treatment

Reuters

06-09

Avidity Biosciences Secures Accelerated Approval Pathway for Del-Brax in the U.S. and Launches Global Phase 3 Study for FSHD Treatment

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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Avidity Biosciences Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: LA05504) on June 09, 2025, and is solely responsible for the information contained therein.

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