FDA Approves High Dose SPINRAZA for SMA Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Mar 30 2026
0mins
Should l Buy BIIB?
Source: NASDAQ.COM
- FDA Approval: Biogen announced that its High Dose SPINRAZA (nusinersen) has been approved by the U.S. FDA for the treatment of spinal muscular atrophy (SMA), backed by over 10 years of clinical data to address ongoing community needs.
- Innovative Dosage Design: The high dose regimen includes 50 mg/5 mL and 28 mg/5 mL doses, designed to deliver a higher concentration of the drug through an accelerated loading phase and maintenance dosing, enabling faster treatment initiation for new patients.
- Clinical Trial Support: The FDA approval is based on data from the three-part Phase 2/3 DEVOTE study, which showed that treatment-naïve symptomatic infants receiving High Dose SPINRAZA experienced statistically significant improvements in motor function compared to a matched sham group from the ENDEAR study, demonstrating the treatment's efficacy.
- Broad Market Outlook: High Dose SPINRAZA will be available in the U.S. in the coming weeks and is also approved in the European Union, Switzerland, and Japan, expected to provide new treatment options for SMA patients globally, further solidifying Biogen's leadership in the neuromuscular disease space.
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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: 177.350
Low
143.00
Averages
204.45
High
246.00
Current: 177.350
Low
143.00
Averages
204.45
High
246.00
About BIIB
Biogen Inc. is a global biopharmaceutical company. The Company is focused on discovering, developing, and delivering advanced therapies for people living with serious and complex diseases worldwide. It operates a portfolio of medicines to treat multiple sclerosis (MS), spinal muscular atrophy (SMA), Alzheimer's disease, and amyotrophic lateral sclerosis (ALS). It is focused on advancing its pipeline in neurology, specialized immunology, and rare diseases. Its marketed products include TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA for the treatment of MS; SPINRAZA for the treatment of SMA; SKYCLARYS for the treatment of Friedreich's Ataxia; QALSODY for the treatment of ALS, and FUMADERM for the treatment of severe plaque psoriasis. It also collaborations with Eisai on the commercialization of LEQEMBI for the treatment of Alzheimer's disease and Sage on the commercialization of ZURZUVAE for the treatment of Postpartum Depression (PPD).
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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- Global Exclusive Rights: Biogen has acquired exclusive worldwide development and commercialization rights to felzartamab by purchasing TJ Biopharma's rights in Greater China, a strategic move that enhances its market position in immune-mediated diseases.
- Financial Terms: Under the agreement, TJ Biopharma will receive a $100 million upfront payment and is eligible for up to $750 million in potential commercial and sales milestone payments, totaling a potential consideration of $850 million, which will significantly support TJ Biopharma's R&D efforts.
- Deepening Clinical Collaboration: This transaction builds on the successful collaboration between TJ Biopharma and Biogen, with both companies achieving positive progress in Phase 3 trials for IgAN and PMN since April 2025, demonstrating the broad applicability of felzartamab in the Chinese market.
- Significant Market Potential: China is believed to have the largest patient population for IgAN and PMN, and Biogen's acquisition will help accelerate the advancement of innovative treatment options to meet the growing market demand, further solidifying its leadership position in the global biopharmaceutical industry.
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- Fertilizer Stocks Fluctuate: Fertilizer stocks experienced volatility as CF Industries rose nearly 2% due to ongoing shipping disruptions in the Strait of Hormuz, while Dow and LyondellBasell Industries also saw gains of about 4% and 2%, respectively, reflecting market reactions to supply chain challenges.
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- Upfront Payment Structure: Under the agreement, Biogen will pay $100 million upfront to Hangzhou-based TJ Bio, which it plans to record as an in-process R&D expense in Q2 2026, reflecting the company's commitment to new drug development.
- Potential for Substantial Earnings: In addition to the upfront payment, TJ Bio is entitled to receive up to $750 million in additional payments based on commercial and sales milestones, which not only enhances Biogen's market competitiveness but also lays the groundwork for future revenue growth.
- Global Clinical Trial Progress: Biogen has initiated global Phase 3 trials for felzartamab targeting immune-related conditions, including IgA nephropathy, further solidifying its position in the global biopharmaceutical market.
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- Future Catalysts: Analysts are optimistic about important immunology and kidney catalysts in the next 12-18 months, believing that investigational drugs like litifilimab, felzartamab, and dapirolizumab present large and currently underappreciated opportunities for the company.
See More
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- Acquisition Agreement: Biogen has entered into a definitive agreement to acquire TJ Bio's exclusive rights to felzartamab in the Greater China Region, marking a strategic expansion in the field of immune-mediated diseases.
- Significant Payment Commitment: Biogen will make a $100 million upfront payment and is eligible for up to $750 million in potential commercial and sales milestone payments, totaling a potential consideration of up to $850 million, indicating strong recognition of the drug's market potential.
- Global Clinical Research: Felzartamab is currently undergoing global Phase 3 clinical studies, with Biogen assuming full responsibility for milestone payments and royalty obligations, further solidifying its leadership position in the biopharmaceutical sector.
- Market Reaction: Despite the acquisition agreement, Biogen's shares fell 1.21% in pre-market trading on NasdaqGS to $175.20, reflecting a cautious market sentiment regarding the deal.
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- Apple's Positive Outlook: Morgan Stanley reiterated Apple as overweight, expecting a modest 1-2% upside in revenue and EPS in the upcoming earnings report, despite supply constraints, indicating the company's resilience in the market.
- Amazon Price Target Increase: Bank of America raised Amazon's price target from $275 to $298, believing that with strong assets and customer focus, Amazon is well-positioned to capitalize on the global growth of eCommerce and enterprise demand for AI capabilities, showcasing robust growth potential.
- Microsoft's Favorable Outlook: Deutsche Bank reiterated Microsoft as a buy, expecting Azure's performance and guidance to be focal points in the upcoming earnings report, indicating that the company's broad progress in AI initiatives will drive future growth.
See More
Biogen Acquires Exclusive Rights to Felzartamab in Greater China
- Global Exclusive Rights: Biogen has acquired exclusive worldwide development and commercialization rights to felzartamab by purchasing TJ Biopharma's rights in Greater China, a strategic move that enhances its market position in immune-mediated diseases.
- Financial Terms: Under the agreement, TJ Biopharma will receive a $100 million upfront payment and is eligible for up to $750 million in potential commercial and sales milestone payments, totaling a potential consideration of $850 million, which will significantly support TJ Biopharma's R&D efforts.
- Deepening Clinical Collaboration: This transaction builds on the successful collaboration between TJ Biopharma and Biogen, with both companies achieving positive progress in Phase 3 trials for IgAN and PMN since April 2025, demonstrating the broad applicability of felzartamab in the Chinese market.
- Significant Market Potential: China is believed to have the largest patient population for IgAN and PMN, and Biogen's acquisition will help accelerate the advancement of innovative treatment options to meet the growing market demand, further solidifying its leadership position in the global biopharmaceutical industry.
See More
Midday Market Moves: Notable Stock Fluctuations
- Stanley Black & Decker Surge: Stanley Black & Decker's stock rose over 4% after the company stated that recent changes to Section 232 tariffs would not materially impact its full-year forecast, indicating strong confidence in its financial outlook.
- Fermi Stock Plunge: Shares of energy infrastructure developer Fermi fell more than 22% following the resignation of CFO Miles Everson and the recent departure of CEO Toby Neugebauer, raising concerns about the company's leadership stability and future direction.
- Biogen's Strategic Move: Biogen's stock increased nearly 3% after agreeing to pay $850 million for exclusive rights to sell felzartamab in China, which underscores its strategic expansion in the immune-related disease treatment market.
- Fertilizer Stocks Fluctuate: Fertilizer stocks experienced volatility as CF Industries rose nearly 2% due to ongoing shipping disruptions in the Strait of Hormuz, while Dow and LyondellBasell Industries also saw gains of about 4% and 2%, respectively, reflecting market reactions to supply chain challenges.
See More
Biogen Acquires Exclusive Rights for Felzartamab in Greater China
- Significant Deal Value: Biogen has reached a deal worth up to $850 million with TJ Bio to acquire exclusive rights for felzartamab in Greater China, demonstrating the company's strong investment intent in the biopharmaceutical sector.
- Upfront Payment Structure: Under the agreement, Biogen will pay $100 million upfront to Hangzhou-based TJ Bio, which it plans to record as an in-process R&D expense in Q2 2026, reflecting the company's commitment to new drug development.
- Potential for Substantial Earnings: In addition to the upfront payment, TJ Bio is entitled to receive up to $750 million in additional payments based on commercial and sales milestones, which not only enhances Biogen's market competitiveness but also lays the groundwork for future revenue growth.
- Global Clinical Trial Progress: Biogen has initiated global Phase 3 trials for felzartamab targeting immune-related conditions, including IgA nephropathy, further solidifying its position in the global biopharmaceutical market.
See More
Biogen Boosted by Focus on Kidney Transplant Drugs, Rating Upgraded
- Rating Upgrade: Wells Fargo upgraded Biogen's stock rating from equal weight to overweight and raised its price target from $200 to $250, indicating a potential upside of approximately 41% from Friday's close, reflecting a positive outlook on the company's growth prospects.
- New Revenue Streams: Analyst Mohit Bansal highlighted that Biogen's late-stage pipeline now includes therapies for lupus and antibody-mediated rejection (AMR) treatments for kidney transplant patients, which will reduce reliance on neurology treatments, with an estimated adjusted sales of around $2.5 billion by 2035.
- Competitive Response: In light of rising competition in the multiple sclerosis (MS) drug market, Biogen's strategic pivot towards immunology and kidney treatments is expected to create new growth avenues, with promising clinical trial data supporting the differentiation of these new drugs.
- Future Catalysts: Analysts are optimistic about important immunology and kidney catalysts in the next 12-18 months, believing that investigational drugs like litifilimab, felzartamab, and dapirolizumab present large and currently underappreciated opportunities for the company.
See More
Biogen Acquires Exclusive Rights to Felzartamab in Greater China
- Acquisition Agreement: Biogen has entered into a definitive agreement to acquire TJ Bio's exclusive rights to felzartamab in the Greater China Region, marking a strategic expansion in the field of immune-mediated diseases.
- Significant Payment Commitment: Biogen will make a $100 million upfront payment and is eligible for up to $750 million in potential commercial and sales milestone payments, totaling a potential consideration of up to $850 million, indicating strong recognition of the drug's market potential.
- Global Clinical Research: Felzartamab is currently undergoing global Phase 3 clinical studies, with Biogen assuming full responsibility for milestone payments and royalty obligations, further solidifying its leadership position in the biopharmaceutical sector.
- Market Reaction: Despite the acquisition agreement, Biogen's shares fell 1.21% in pre-market trading on NasdaqGS to $175.20, reflecting a cautious market sentiment regarding the deal.
See More
Major Wall Street Rating Updates on Monday
- Tesla Rating Adjustment: Jefferies raised Tesla's price target from $300 to $350, anticipating Q1 results will show a widening gap between vision and execution, and concerns about funding may arise without a convincing robotaxi announcement, potentially leading to merger considerations with SpaceX.
- Apple's Positive Outlook: Morgan Stanley reiterated Apple as overweight, expecting a modest 1-2% upside in revenue and EPS in the upcoming earnings report, despite supply constraints, indicating the company's resilience in the market.
- Amazon Price Target Increase: Bank of America raised Amazon's price target from $275 to $298, believing that with strong assets and customer focus, Amazon is well-positioned to capitalize on the global growth of eCommerce and enterprise demand for AI capabilities, showcasing robust growth potential.
- Microsoft's Favorable Outlook: Deutsche Bank reiterated Microsoft as a buy, expecting Azure's performance and guidance to be focal points in the upcoming earnings report, indicating that the company's broad progress in AI initiatives will drive future growth.
See More
