Biogen high-dose Spinraza approval seen supporting long-term growth [Yahoo! Finance]
Biogen Inc. (BIIB)
Last biogen inc. earnings: 4/22 07:12 am
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Source: Yahoo! Finance
The US Food and Drug Administration has approved a higher-dose version of Spinraza, a key therapy from Biogen Inc (NASDAQ:BIIB, XETRA:IDP) for spinal muscular atrophy (SMA), a move analysts at Jefferies say could help sustain the company's long-standing position in the rare disease market. According to the analysts, the decision was largely anticipated by investors despite earlier regulatory delays tied to manufacturing issues described as “benign.” The newly approved regimen, often referred to as high-dose Spinraza, is expected to reinforce the durability of Biogen's SMA franchise, which generates more than $1.5 billion annually. Spinraza, also known as nusinersen, has been a cornerstone SMA therapy for years. The updated dosing approach includes larger loading doses followed by higher maintenance levels, which analysts say may address the “waning-off effect experienced by patients” and improve the overall durability of response. This could also expand uptake among adult patie
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News
- Biogen to acquire Apellis Pharmaceuticals for $5.6B, adding C3 therapies to portfolio [Yahoo! Finance]Yahoo! Finance
- Biogen to Acquire Apellis, Enhancing the Company’s Growth Portfolio in Immunology and Rare Disease, Bolstering Growth Outlook and Accelerating Expansion into NephrologyGlobeNewswire
- FDA Approves New High Dose Regimen of SPINRAZA® (nusinersen) for Spinal Muscular Atrophy [Yahoo! Finance]Yahoo! Finance
- FDA Approves New High Dose Regimen of SPINRAZA® (nusinersen) for Spinal Muscular AtrophyGlobeNewswire
- Biogen Announces Second Positive Phase 2 Litifilimab Trial in Cutaneous Lupus Erythematosus at 2026 American Academy of Dermatology Annual Meeting, Showing a Significant Reduction in Skin Disease Activity [Yahoo! Finance]Yahoo! Finance
BIIB
Earnings
- 2/9/26 - Beat
BIIB
Sec Filings
- 3/31/26 - Form 8-K
- 3/26/26 - Form SCHEDULE
- 3/11/26 - Form 8-K
- BIIB's page on the SEC website