Biogen Reports Long-Term QALSODY Data Showing Slowed SOD1-ALS Progression in Phase 3 Study

Reuters00:20

Biogen Reports Long-Term QALSODY Data Showing Slowed SOD1-ALS Progression in Phase 3 Study

Biogen Inc. announced that The Journal of the American Medical Association (JAMA) Neurology has published final results from the completed Phase 3 VALOR study and its open-label extension evaluating QALSODY (tofersen) for the treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). The published long-term data, with over 3.5 years of follow-up, indicate that early initiation of QALSODY was associated with a numerically slower decline in clinical function, breathing, and strength, as well as a reduction in the risk of death or permanent ventilation. Sustained reductions in neurofilament, a marker of neurodegeneration, were also observed. In addition, QALSODY is being studied in the ongoing Phase 3 ATLAS trial to assess whether it can delay clinical onset of ALS in presymptomatic individuals with a SOD1 genetic mutation. These results have already been presented through publication in JAMA Neurology.

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. Biogen Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9616065-en) on December 22, 2025, and is solely responsible for the information contained therein.

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