Biogen’s Salanersen Receives FDA Breakthrough Therapy Designation for Spinal Muscular Atrophy
Biogen's salanersen has received FDA Breakthrough Therapy Designation for spinal muscular atrophy (SMA), supported by Phase 1b data showing clinically meaningful improvements in motor function and slowing of neurodegeneration in children previously treated with gene therapy. Salanersen is an investigational antisense oligonucleotide with once-yearly dosing, now advancing into Phase 3 studies to address unmet needs in the SMA community.
https://www.globenewswire.com/news-release/2026/06/04/3306663/0/en/biogen-s-salanersen-receives-fda-breakthrough-therapy-designation-for-spinal-muscular-atrophy.html