Biogen's High Dose SPINRAZA Approved for SMA Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Mar 30 2026
0mins
Source: Newsfilter
Biogen Inc's stock fell 4.42% as it hit a 20-day low amid a strong market rally, with the Nasdaq-100 up 1.69% and the S&P 500 up 1.49%.
The U.S. FDA has approved Biogen's High Dose SPINRAZA (nusinersen) for spinal muscular atrophy (SMA), which includes new dosing options designed to enhance treatment efficacy and flexibility. This approval is supported by clinical data from the Phase 2/3 DEVOTE study, showing significant improvements in motor function for treatment-naïve infants. The new regimen is expected to be available in the U.S. in the coming weeks, further solidifying Biogen's position in the neuromuscular disease market.
This FDA approval represents a significant advancement for SMA treatment, potentially increasing Biogen's market share and addressing urgent patient needs. However, the stock's decline may reflect profit-taking or sector rotation despite the positive news.
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Analyst Views on BIIB
Wall Street analysts forecast BIIB stock price to rise
26 Analyst Rating
11 Buy
14 Hold
1 Sell
Moderate Buy
Current: 196.390
Low
143.00
Averages
204.45
High
246.00
Current: 196.390
Low
143.00
Averages
204.45
High
246.00
About BIIB
Biogen Inc. is a biotechnology company. The Company is focused on discovering, developing and delivering therapies. It has a portfolio of medicines to treat Multiple Sclerosis (MS), has introduced an approved treatment for Spinal Muscular Atrophy (SMA), co-developed treatments to address a defining pathology of Alzheimer's disease and launched an approved treatment to target a genetic cause of Amyotrophic Lateral Sclerosis (ALS). It markets a drug approved in United States, European Union and certain international markets for the treatment of Friedreich Ataxia (FA) in adults and adolescents aged 16 years and older. It is focused on advancing its pipeline in neurology, specialized immunology and rare diseases. Its marketed products include VUMERITY, TYSABRI, TECFIDERA, AVONEX and PLEGRIDY for the treatment of MS; SPINRAZA for the treatment of SMA; SKYCLARYS for the treatment of FA, and QALSODY for the treatment of ALS. Its commercialized products also include EMPAVELI and SYFOVRE.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Market Reaction: Following the release of the CELIA trial data, Biogen's stock experienced a sharp decline on heavy trading volume, reflecting investor concerns about the company's future prospects, especially given management's previous confidence expressed during the Q1 2025 earnings call.
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- Mechanism Exploration: BIIB122 was designed to inhibit the LRRK2 mutation associated with Parkinson's disease; despite the disappointing results, Denali's medical chief, Peter Chin, emphasized the need for further exploration of LRRK2 as a potential therapeutic target, indicating future research directions.
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See More
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- Clinical Trial Results: Biogen and Denali's BIIB122 did not meet primary and secondary endpoints in the LUMA study, leading to the decision to discontinue its development for idiopathic Parkinson's disease, indicating the drug's ineffectiveness in slowing disease progression.
- Study Participation: The LUMA trial enrolled 648 adults aged 30 to 80 with early-stage Parkinson's disease, with participants receiving either BIIB122 or placebo for 48 to 144 weeks, designed to test whether LRRK2 inhibition could improve underlying disease biology.
- Biomarker Data: Despite the lack of clinical efficacy, exploratory biomarker data confirmed over 90% inhibition of peripheral LRRK2 activity and a 30% reduction in cerebrospinal fluid biomarkers in a sub-study, suggesting potential biological mechanisms for the drug.
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