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Biogen Inc. Press Release: Biogen to Share New SMA Data at Muscular Dystrophy Association and SMA Europe Conferences
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2026-03-05
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# Biogen to Share New SMA Data at Muscular Dystrophy Association and SMA Europe Conferences **Date:** 2026-03-05 07:30:00 **Company:** Biogen Inc. **Ticker:** BIIB **Source URL:** https://www.globenewswire.com/news-release/2026/03/05/3250050/0/en/Biogen-to-Share-New-SMA-Data-at-Muscular-Dystrophy-Association-and-SMA-Europe-Conferences.html --- [Accessibility: Skip TopNav](https://www.globenewswire.com/news-release/2026/03/05/3250050/0/en/Biogen-to-Share-New-SMA-Data-at-Muscular-Dystrophy-Association-and-SMA-Europe-Conferences.html#maincontainer) [](https://www.globenewswire.com/) - [Newsroom](https://www.globenewswire.com/newsroom) - [Services](https://www.globenewswire.com/services) - [Contact Us](https://insight.notified.com/globenewswire-contact-us?utm_medium=Website&utm_source=Contact%20Us&utm_campaign=Contact%20Us%20ENG) - English [Sign In](https://www.globenewswire.com/home/signin) [Reg...
# Biogen to Share New SMA Data at Muscular Dystrophy Association and SMA Europe Conferences **Date:** 2026-03-05 07:30:00 **Company:** Biogen Inc. **Ticker:** BIIB **Source URL:** https://www.globenewswire.com/news-release/2026/03/05/3250050/0/en/Biogen-to-Share-New-SMA-Data-at-Muscular-Dystrophy-Association-and-SMA-Europe-Conferences.html --- [Accessibility: Skip TopNav](https://www.globenewswire.com/news-release/2026/03/05/3250050/0/en/Biogen-to-Share-New-SMA-Data-at-Muscular-Dystrophy-Association-and-SMA-Europe-Conferences.html#maincontainer) [](https://www.globenewswire.com/) - [Newsroom](https://www.globenewswire.com/newsroom) - [Services](https://www.globenewswire.com/services) - [Contact Us](https://insight.notified.com/globenewswire-contact-us?utm_medium=Website&utm_source=Contact%20Us&utm_campaign=Contact%20Us%20ENG) - English [Sign In](https://www.globenewswire.com/home/signin) [Register](https://portal.notified.com/en/registration) # [](https://www.biogen.com/) # Biogen to Share New SMA Data at Muscular Dystrophy Association and SMA Europe Conferences March 05, 2026 07:30 ET\| Source: [Biogen Inc.](https://www.globenewswire.com/en/search/organization/Biogen%2520Inc%C2%A7)FollowBiogen Inc. * * * Share - * * * - 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.](https://www.globenewswire.com/Tracker?data=o4gz7XiqoX49QB2C3LdzmcHFwZgCTAiC2nwzYrikq5-6pHyQ3dM0V1wh4zqzIJ3FT2ClxMkIpK80x_m-VA6DBg== "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 5th 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). 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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. These forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. 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Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise. **Digital Media Disclosure** From time to time we have used, or expect in the future to use, our investor relations website ( [investors.biogen.com](https://www.globenewswire.com/Tracker?data=a6z5oNv6dBcUJV4Xp9nBEddam_Pf-HN8HKBOryf6HROCt24DN0-Ns32IXyWR0ALvj6lWtDDVATS9Ql0VykMUIRl9F6xVo3yvNgco1hAYBst2Eg1qlROpej3G8I0b_jxO1JDNIhTmJ4be2yL-uh8ljD7mypqJtU0yglei3Gdm_WGrBU2ZDj34xGPCAGkJzs_YF8hH7A-xG23D72RljTvLpXR6s3la6CM_9Zyc6sXpp6ohm6WGB7nJjWc1ZVt5E9qZTbr8PnEOByt9OrcRZnVi3ZTq6j96IZTCkTRL4rZKrWAwp8Xw9NhyJqd8GWDDZGi2OE6JzqpmFxC-TGOzNOILh9NwYEx0N6GfhNn1L7Xa6IqGG1BqapnnfsJiUuJQU-bCmR026F79jJE7fkzoxyijDTtHq7ED7UE-9MrkGKAcLiEQEj8eJZRwl_UCNq7drryf9fOMHjfxZC62sJRiWCRm2m0oECpSiXDCv81b5efPzv4wOLLkDFOBM5EGA3cpgq8EJTVBTKpMT3EBIjPOZPBfUldXWC9bughKspC_3AHNIcrzRo1QBFgopbDZUo7sRSsNpx_3sRyJT5OmXTuAg7gJ3jxfzqvdC_wY7zSljVdDr8G2uCHt6wuFmL3njNtUtoq7xRnXOwqhLCuC8VCFjKUsIGwLDGyMH8FQuJiU0OOFMRsk0gRBZrftaDFcB-IWqcrYPwjkAxqfc-ovJ05yOyqcoSFvTzCpxvP4J748hr2M0eviUNYii97oiaZzLwTyyNehRMbTj8rOPel_MdjZgDLOwqk3f1ndVcCQcurL3vpX721Bepf8qhWFmae0RSq-qXorQgvejkXR6hrUBzavgYeJ2BnihlUc1zDwaVOcpniHJsj2IsxtyWel9dqRR6JIMGQDPN28QescjFGHsgIEKNp2ZnAHaFouhyP1QjYANYhShKaYV3jqhbJ80IVWutL5Iuyp0X7PYei0Rtv37qpW81thHQ== "investors.biogen.com")), the Biogen LinkedIn account ( [linkedin.com/company/biogen-](https://www.globenewswire.com/Tracker?data=uCZcIAngmxLIxbxlcoqaXiBT--FHoiBZhCMgcCwX905vOiUkQAZoOY5boBsX7Pl1wl4uWSkrnhBbnvejVDnm2Dgd_5ZauOQM-_k0XMm9ETjD255h_TauVZTS1HPqLQhia5-Njudr7ak2rOUNUoO1gNiZzxwShbDPU-5bPu0DkEDl3wN2myO_Wp_1KmGLEmf-vRU1hQLIGl-RQuMdrvhZYl6K7Z0aGLQNcGrakx_TWESIx-QCzEmmpl81H7LB5Ade8LkSW113iaO7_d3MWWgGgICt_loYxOIVh_ePQKSDrmufrfSZH66AmQUGmoWEsgOx6ODjpZTgQS0r2WUOMZxMgA== "linkedin.com/company/biogen-")) and the Biogen X account ( [https://x.com/biogen](https://www.globenewswire.com/Tracker?data=s4i4KPJGnw5c0YUwYdwarfy42UuVUcMbtm6F2ACAK16k-oVfjMCx86dD6VWOQI4VQKNGwQRGLbBwJn39XAZxmcrCdJ-a-l8hltnvkNcVqINXH7vyueflfuHUKx4g4O7hi3Tq7hIW8X3kCIeu3i7RRrnAWwpBOASDoqzCblQmZwPN_hl8UDSUCK6WnZBEXPEy--nKuKcIKNjCOp0pCsTeY9ejIoQRfx35Yw0yjncxVqyClM8oi1NW-peV12E9uz5ZkeiEaASyBxb0IJ-wIdFvPw== "")) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and this social media channel in addition to our press releases, SEC filings, public conference calls and webcasts, as the information posted on them could be material to investors. _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.” | | | | --- | --- | | | | | MEDIA CONTACT:<br>**Biogen**<br>Madeleine Shin<br>+1-781-464-3260<br>[public.affairs@biogen.com](mailto:public.affairs@biogen.com "public.affairs@biogen.com") | INVESTOR CONTACT:<br>**Biogen**<br>Tim Power<br>+1 781 464 2442<br>[IR@biogen.com](mailto:IR@biogen.com "IR@biogen.com") |  * * * ## Tags [rare disease](https://www.globenewswire.com/en/search/tag/rare%2520disease "rare disease")[sma](https://www.globenewswire.com/en/search/tag/sma "sma")[muscular dystrophy association](https://www.globenewswire.com/en/search/tag/muscular%2520dystrophy%2520association "muscular dystrophy association")[spinal musc](https://www.globenewswire.com/en/search/tag/spinal%2520musc "spinal musc") GlobeNewswire Company ProfileBiogen Inc.Industry: BiotechnologyWebsite: [https://www.biogen.com/](https://www.biogen.com/) Press Release Actions - [Print](https://www.globenewswire.com/news-release/2026/03/05/3250050/0/en/Biogen-to-Share-New-SMA-Data-at-Muscular-Dystrophy-Association-and-SMA-Europe-Conferences.html?print=1) - [Download PDF](https://www.globenewswire.com/news-release/2026/03/05/3250050/0/en/Biogen-to-Share-New-SMA-Data-at-Muscular-Dystrophy-Association-and-SMA-Europe-Conferences.html?pdf=1) - [Subscribe via RSS](https://www.globenewswire.com/rssfeed/organization/hNQxyS-FvexsgfoXWT62ZA==) - [Subscribe via ATOM](https://www.globenewswire.com/atomfeed/organization/hNQxyS-FvexsgfoXWT62ZA==) - [Javascript](https://www.globenewswire.com/JSWidget/organization/1Auq0gGEGXtj4JiJ1VLRjw%3d%3d) ## Recommended Reading - March 04, 2026 17:05 ET\|Source: [Biogen Inc.](https://www.globenewswire.com/en/search/organization/Biogen%2520Inc%C2%A7) [The New England Journal of Medicine Publishes First Data to Demonstrate the Potential for Disease Modification in Dravet Syndrome](https://www.globenewswire.com/news-release/2026/03/04/3249779/0/en/The-New-England-Journal-of-Medicine-Publishes-First-Data-to-Demonstrate-the-Potential-for-Disease-Modification-in-Dravet-Syndrome.html) –Results show that targeting the underlying cause of Dravet syndrome with zorevunersen may improve outcomes for people with this rare, devastating genetic neurodevelopmental disease– –Data support... 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Watch later Share Copy link [Why am I seeing this?](https://support.google.com/youtube/answer/9004474?hl=en) Watch on 0:00 0:00 / 2:35 •Live • March 05, 2026 07:31 ET [Virtuix Reports Third Quarter and Nine-Month Fisca...](https://www.globenewswire.com/news-release/2026/03/05/3250057/0/en/Virtuix-Reports-Third-Quarter-and-Nine-Month-Fiscal-2026-Financial-Results.html "Virtuix Reports...") [](https://www.globenewswire.com/news-release/2026/03/05/3250048/0/en/Helus-Pharma-Announces-Topline-Results-in-Phase-2-Signal-Detection-Study-for-HLP004-in-Patients-with-Generalized-Anxiety-Disorder.html) March 05, 2026 07:30 ET [Helus Pharma Announces Topline Results in Phase 2 ...](https://www.globenewswire.com/news-release/2026/03/05/3250048/0/en/Helus-Pharma-Announces-Topline-Results-in-Phase-2-Signal-Detection-Study-for-HLP004-in-Patients-with-Generalized-Anxiety-Disorder.html "Helus Pharma...") 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Watch later Share Copy link [Why am I seeing this?](https://support.google.com/youtube/answer/9004474?hl=en) Watch on 0:00 0:00 / 2:35 •Live • March 05, 2026 07:31 ET [Virtuix Reports Third Quarter and Nine-Month Fisca...](https://www.globenewswire.com/news-release/2026/03/05/3250057/0/en/Virtuix-Reports-Third-Quarter-and-Nine-Month-Fiscal-2026-Financial-Results.html "Virtuix Reports...") [](https://www.globenewswire.com/news-release/2026/03/05/3250048/0/en/Helus-Pharma-Announces-Topline-Results-in-Phase-2-Signal-Detection-Study-for-HLP004-in-Patients-with-Generalized-Anxiety-Disorder.html) March 05, 2026 07:30 ET [Helus Pharma Announces Topline Results in Phase 2 ...](https://www.globenewswire.com/news-release/2026/03/05/3250048/0/en/Helus-Pharma-Announces-Topline-Results-in-Phase-2-Signal-Detection-Study-for-HLP004-in-Patients-with-Generalized-Anxiety-Disorder.html "Helus Pharma...") 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