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March 11, 2026 08:00 ET | Source: Biogen Inc.

Biogen Presents Additional Salanersen Data Showing New Motor Milestones Achieved in Children with SMA Previously Treated with Gene Therapy

New Phase 1b data support the safety and effectiveness of salanersen over one year in children with SMA who had the potential for improvement due to suboptimal clinical status with prior gene...
March 05, 2026 07:30 ET | Source: 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,...
February 04, 2026 07:30 ET | Source: Biogen Inc.

Nature Medicine Publishes Results from the Pivotal DEVOTE Study of High-Dose Regimen of Nusinersen in Spinal Muscular Atrophy

Findings from DEVOTE support clinical benefits of the high-dose regimen of nusinersen (50 mg and 28 mg) in both treatment-naïve individuals and those previously treated with 12 mg nusinersenThe...
January 12, 2026 11:05 ET | Source: Biogen Inc.

Biogen Receives European Commission Approval for High Dose Regimen of SPINRAZA® (nusinersen) for Spinal Muscular Atrophy

Approval is supported by data from the DEVOTE study which showed the benefit of the SPINRAZA 50 mg and 28 mg regimen in both treatment-naïve and previously-treated nusinersen patients with SMA1Biogen...
November 24, 2025 22:21 ET | Source: Muscular Dystrophy Association

Muscular Dystrophy Association Calls FDA Approval of Novartis’ Itvisma (onasemnogene abeparvovec-brve) a Major Step Forward for the Spinal Muscular Atrophy Community

New York, Nov. 24, 2025 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) today called the U.S. Food and Drug Administration’s approval of Itvisma (onasemnogene abeparvovec-brve),...
October 27, 2025 00:01 ET | Source: Genie AI LLC

Allo by GenieAI Goes Live for All Clients Following Successful Singapore Launch

GenieAI launches Allo, the first data platform for live, verified crypto SMA track records.
June 27, 2025 10:00 ET | Source: Biogen Inc.

New Data for Nusinersen Underscore Biogen’s Commitment to Advancing Clinical Research to Improve Outcomes in SMA

New analyses from DEVOTE Part C further characterize the improvements in motor function in participants with SMA who transitioned to the investigational higher dose regimen of nusinersen from 12 mg...
June 25, 2025 07:30 ET | Source: Biogen Inc.

Biogen to Advance Investigational Spinal Muscular Atrophy Asset to Registrational Studies Based on Positive Interim Phase 1 Results

Salanersen (BIIB115/ION306) is a novel antisense oligonucleotide (ASO) with the potential to achieve high efficacy and once yearly dosing in spinal muscular atrophy (SMA)Interim Phase 1 data show...
February 12, 2025 12:48 ET | Source: Muscular Dystrophy Association

FDA Approves New Tablet Form of Evrysdi for Treatment of Spinal Muscular Atrophy

New York, Feb. 12, 2025 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) today celebrates the decision by the US Food and Drug Administration (FDA) to grant approval of a risdiplam...
January 23, 2025 07:30 ET | Source: Biogen Inc.

FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA

CAMBRIDGE, Mass., Jan. 23, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application...