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Avidity报告BLA前会议对Duchenne肌肉萎缩症资产del-zota的积极评价
2025-10-13 23:05
- Avidity Biosciences (NASDAQ:RNA) said that it will submit a BLA for its Duchenne muscular dystrophy candidate delpacibart zotadirsen (del-zota) in Q1 2026 following a pre-BLA meeting with the US FDA.
- The submission was originally planned for by the end of 2025, but has been changed "to ensure the FDA receives additional data to support the chemistry, manufacturing, and controls package at time of submission," the company stated.
- Del-zota has Breakthrough Therapy designation and is under investigation for individuals with Duchenne muscular dystrophy who have gene mutations amenable to exon 44 skipping (DMD44).
More on Avidity Biosciences
- Avidity Biosciences: Maintaining 'Strong Buy' Rating Based On Accelerated Approval Filing For Del-Zota
- Avidity Biosciences, Inc. (RNA) Discusses On Redefining The Treatment Of Duchenne Muscular Dystrophy (Transcript)
- Redefining the Treatment of Duchenne Muscular Dystrophy Presentation
- Avidity Biosciences prices $600M stock offering
- Avidity Biosciences reports data from DMD treatment trials
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