Biogen Eyes Wave of Phase III Readouts as It Expands Beyond Neuroscience

Biogen expects a wave of late-stage results: Ten Phase III trials could begin producing data as soon as next quarter, potentially supporting eight launches or new indications across five molecules. The company is diversifying beyond neuroscience through acquisitions and development programs in immunology, kidney disease and ophthalmology, including felzartamab, SYFOVRE and EMPAVELI. Key upcoming catalysts include lupus and kidney-disease data: Litifilimab’s systemic lupus results are expected in the fourth quarter, while felzartamab data in antibody-mediated rejection are anticipated in the first half of next year. Biogen NASDAQ: BIIB is reshaping its business around a broader mix of neuroscience, immunology, kidney disease and ophthalmology assets, President and CEO Chris Viehbacher said during a Morgan Stanley event. The company expects a series of late-stage clinical readouts to begin as soon as next quarter and said its recently acquired assets could help accelerate revenue growth. Viehbacher said the company’s prior strategy was concentrated in neuroscience, with expensive late-stage programs and a narrow commercial footprint focused on neurologists. Biogen now calls on a wider range of specialists, including nephrologists, transplant nephrologists, rheumatologists, dermatologists, epileptologists and retina specialists. Get Biogen alerts: Sign Up Biogen Stock Slides After Trial Miss, But Analysts Stay Bullish “Internally, we talk about new Biogen,” Viehbacher said, describing the company’s effort to retain its neuroscience roots while expanding into immunology and other areas with potentially shorter, more defined Phase II studies. Pipeline and business development strategy Biogen’s business-development activity has included the acquisition of Human Immunology Biosciences, or Hi-Bio, which added felzartamab, and the acquisition of Apellis Pharmaceuticals. Viehbacher said both transactions fit the company’s focus on immunology, including rare and smaller indications. 3 Biotech Stocks That Look Like “Sure-Fire” Winners in 2026 He said Biogen has 10 Phase III trials that are expected to start producing results as soon as the next quarter. Those trials could support eight product launches or new indications involving five molecules, according to Viehbacher. Looking ahead, Biogen intends to focus capital deployment on earlier-stage opportunities, including preclinical, Phase I and Phase II assets. Viehbacher said early development is also the most capital-efficient stage for acquisitions, although competition remains high in immunology because disease biology is well defined in some areas. He added that the pool of early-stage assets has expanded with the emergence of China-based drug development. LEQEMBI access and Alzheimer’s development Viehbacher said Alzheimer’s treatment uptake for LEQEMBI has been slower than some expected despite substantial unmet need. He attributed the pace in part to operational changes required at neurology practices, including arranging PET scans, MRIs, cognitive assessments, infusion capacity and supporting staff. Biogen and partner Eisai are working to simplify the treatment pathway, he said. Blood-based diagnostics may reduce reliance on PET scans, which Viehbacher said can cost about $5,000, compared with less than $130 for a blood-based diagnostic. The company has also seen the proportion of eligible patients among those referred improve from 50% to 70% as blood-based testing is increasingly used in primary care settings, he said. Biogen received approval for a subcutaneous LEQEMBI maintenance formulation last year and an induction formulation this year. Viehbacher ...