CAMBRIDGE, Mass. — March 5, 2026 — Leads & Copy — 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 and the 5th International Scientific Congress on SMA (SMA Europe 2026).
According to Stephanie Fradette, Pharm,D., Head of the Neuromuscular Development Unit at Biogen, the company has remained steadfast in its pursuit of scientific innovation to support the evolving efficacy needs of the SMA community.
Fradette added that Biogen is at an important juncture for its SMA portfolio as it looks to bring the high dose regimen of nusinersen to the community and advance salanersen into registrational studies.
The company is excited to share new longer-term data on high dose nusinersen and salanersen, cross-study neurofilament data, and the design of its salanersen Phase 3 studies.
Data on nusinersen will be presented in two posters at the MDA and SMA Europe conferences. The first poster, “Exploring Higher Doses of Nusinersen in Spinal Muscular Atrophy (SMA): Integrated Results from the DEVOTE Part B and ONWARD Studies,” will be presented at MDA on Sunday, March 8, from 6:00-8:00 pm ET (Poster 101S) and at SMA Europe on Thursday, March 12, from 4:15-530 pm CEST (P69).
The second poster, “DEVOTE Part C and ONWARD Integrated Results: Higher Doses of Nusinersen in Nusinersen-Experienced Participants with Spinal Muscular Atrophy (SMA),” will be presented at MDA on Wednesday, March 11, at 8:15 am ET (Florida 4) and at SMA Europe on Friday, March 13, from 4:15-530 pm CEST (P70).
Salanersen data will be presented in three posters at the MDA and SMA Europe conferences. The first poster, “STELLAR Phase 3 Studies to Evaluate the Efficacy and Safety of Salanersen in Infants with Spinal Muscular Atrophy (SMA),” will be presented at MDA on Monday, March 9, from 6:00 – 8:00 pm ET (Poster 199M) and at SMA Europe on Thursday, March 12, from 4:15 – 530 pm CEST (P72).
The second poster, “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),” will be presented at MDA on Monday, March 9, from 6:00 – 8:00 pm ET (Poster 193M) and at SMA Europe on Thursday, March 12, from 4:15-530 pm CEST (P67).
The third poster, “Phase 1 Interim Results Evaluating the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Salanersen for Spinal Muscular Atrophy,” will be presented at MDA on Wednesday, March 11, at 8:00 am ET (Florida 4) and at SMA Europe on Thursday, March 12, from 4:15-530 pm CEST (P71).
An additional poster on Neurofilament Light Chain as a Biomarker in Spinal Muscular Atrophy (Poster 195M) will be presented at MDA only on Monday, March 9, from 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.
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. 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, 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).
Founded in 1978, Biogen is a biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and communities. The company applies deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Biogen routinely posts information that may be important to investors on its website.
