Avidity Biosciences Says Accelerated Approval Regulatory Pathway In United States Is Open For Del-Brax In Treatment Of Facioscapulohumeral Muscular Dystrophy

Benzinga · 06/09 11:10

-- Planning accelerated approval BLA submission in H2 2026, following topline data from

FORTITUDE™ biomarker cohort in Q2 2026 --

-- Initiated global, confirmatory Phase 3 FORWARD™ study of del-brax 2mg/kg

every six weeks --

-- Investor and analyst webcast event today, Monday, June 9, 2025 at 8 a.m. ET --

SAN DIEGO, June 9, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (NASDAQ:RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™) to profoundly improve people's lives, today announced the accelerated approval regulatory pathway in the United States is open for delpacibart braxlosiran (del-brax) in the treatment of facioscapulohumeral muscular dystrophy (FSHD). Additionally, the Company announced that it has initiated its global, confirmatory, Phase 3 FORWARD™ study intended to support a subsequent full approval package for del-brax for people living with FSHD in the U.S. and additional countries around the world.