Biogen Inc.

Biogen to Share New SMA Data at Muscular Dystrophy Association and SMA Europe Conferences

• Long-term data from DEVOTE/ONWARD studies show benefits of high dose nusinersen in people living with spinal muscular atrophy (SMA)
• New Phase 1b data further illustrate potential of salanersen in SMA, as Phase 3 studies begin to evaluate this investigational drug that has the potential for high potency with once-yearly dosing

CAMBRIDGE, Mass., March 05, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – will present new data and updates from its spinal muscle atrophy (SMA) research programs, including high dose nusinersen and salanersen, at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference (March 8-11, 2026) and 5^th International Scientific Congress on SMA (SMA Europe 2026; March 11-14, 2026).

“Over the past decade, we have remained steadfast in our pursuit of scientific innovation to support the evolving efficacy needs of the SMA community. We are at an important juncture for our SMA portfolio as we look to bring the high dose regimen of nusinersen to the community and advance salanersen into registrational studies,” said Stephanie Fradette, Pharm,D., Head of the Neuromuscular Development Unit at Biogen. “We are excited to share new longer-term data on high dose nusinersen and salanersen, cross-study neurofilament data, and the design of our salanersen Phase 3 studies.”

Highlights of Biogen’s SMA Data Presented at MDA and SMA Europe

Nusinersen

• Exploring Higher Doses of Nusinersen in Spinal Muscular Atrophy (SMA): Integrated Results from the DEVOTE Part B and ONWARD Studies
  • MDA: Poster 101S – Sunday, 8 March – 6:00-8:00 pm ET
  • SMA Europe: P69 – Thursday, 12 March – 4:15-530 pm CEST
• DEVOTE Part C and ONWARD Integrated Results: Higher Doses of Nusinersen in Nusinersen-Experienced Participants with Spinal Muscular Atrophy (SMA)
  • MDA: Florida 4 - Wednesday, 11 March – 8:15 am ET
  • SMA Europe: P70 – Friday, 13 March – 4:15-530 pm CEST

Salanersen

• STELLAR Phase 3 Studies to Evaluate the Efficacy and Safety of Salanersen in Infants with Spinal Muscular Atrophy (SMA)
  • MDA: Poster 199M - Monday, 9 March – 6:00 – 8:00 pm ET
  • SMA Europe: P72 – Thursday, 12 March – 4:15 – 530 pm CEST
• The SOLAR study: Phase 3 Study to Evaluate the Efficacy and Safety of Salanersen in Participants Aged 15–60 Years with Spinal Muscular Atrophy (SMA)
  • MDA: Poster 193M - Monday, 9 March 6:00 – 8:00 pm ET
  • SMA Europe: P67 – Thursday, 12 March – 4:15-530 pm CEST
• Phase 1 Interim Results Evaluating the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Salanersen for Spinal Muscular Atrophy
  • MDA: Florida 4 - Wednesday, 11 March – 8:00 am ET
  • SMA Europe: P71 – Thursday, 12 March – 4:15-530 pm CEST
    

MDA Only

• Neurofilament Light Chain as a Biomarker in Spinal Muscular Atrophy
  • Poster 195M - Monday, 9 March 6:00 – 8:00 pm ET

DEVOTE is a Phase 2/3 study that examined the clinical efficacy, safety and tolerability of high dose nusinersen in SMA. ONWARD is a Phase 3 long-term extension for those who previously participated in the DEVOTE study, primarily assessing long-term safety. The high dose regimen of nusinersen, known as SPINRAZA, is also approved in Japan, the European Union, and Switzerland, and is under review with the U.S. Food and Drug Administration (FDA) with a decision expected by April 3, 2026 and other geographies around the world. Biogen is working with regulatory authorities around the world to progress this additional dosing option for people living with SMA.

Biogen licensed the global development, manufacturing and commercialization rights for salanersen from Ionis Pharmaceuticals, Inc. Salanersen was discovered by Ionis.

About SPINRAZA
The high dose regimen of SPINRAZA (nusinersen) comprising a 50 mg/5 mL loading dose and 28 mg/5 mL maintenance dose injections is currently approved in the European Union, Japan, and Switzerland to treat infants, children and adults with spinal muscular atrophy (SMA).

The low dose regimen of SPINRAZA comprising 12 mg/5 mL injection is approved for SMA in more than 71 countries.¹ It has shown efficacy across ages and SMA types with a well-established safety profile based on data in patients treated up to 10 years,^2,3 combined with unsurpassed real-world experience. The most common adverse events observed in clinical studies were respiratory infection, fever, constipation, headache, vomiting and back pain. Laboratory tests can monitor for renal toxicity and coagulation abnormalities, including acute severe low platelet counts, which have been observed after administration of some ASOs. 

Biogen licensed the global rights to develop, manufacture and commercialize SPINRAZA from Ionis Pharmaceuticals, Inc. (Nasdaq: IONS). Please click here for Important Safety Information and full Prescribing Information.

About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media - Facebook, Instagram, LinkedIn, X, YouTube.

Biogen Safe Harbor 
This news release contains forward-looking statements, including, among others, relating to: the potential benefits, efficacy and safety of a High Dose Regimen of nusinersen (SPINRAZA) and salanersen; the potential to advance care and improve outcomes for, and address unmet needs of, patients with SMA; potential regulatory discussions, submissions, decisions and approvals and the timing thereof; the anticipated benefits, risks and potential of our collaboration arrangements; the potential of our commercial business and pipeline programs, including Biogen’s SMA research programs; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would” or the negative of these words or other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.

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References:

1. Based on commercial patients, early access patients, and clinical trial participants through December 31, 2024. 
2. Core Data sheet, Version 13, October 2021. SPINRAZA. Biogen Inc, Cambridge, MA.
3. Finkel et al. Cure SMA 2024. “Final Safety and Efficacy Data From the SHINE Study in Participants With Infantile-Onset and Later-Onset SMA.”