BIOGEN INC.

Eisai and Biogen announced positive real-world results from the LEADER Study for LEQEMBI in early Alzheimer's disease. The study showed that nearly 83% of patients (82.5%) remained stable or improved over an average of 17 months of treatment, with 75.9% stable and 6.6% improving. These outcomes were consistent across diverse patient demographics, and the safety profile aligned with the FDA-approved label, with no new severe ARIA events reported during maintenance therapy. The findings suggest long-term benefits and high treatment persistence for LEQEMBI.

Biogen announced positive Phase 2 CELIA study data for diranersen, an investigational tau-targeting therapy for early Alzheimer's disease. The study demonstrated meaningful clinical efficacy, with the 60 mg dose showing significant slowing of cognitive decline (e.g., 42% on ADAS-Cog13, 50% on MMSE, 26% on CDR-SB), and robust biomarker effects, including 50-65% reduction in CSF total tau. Despite not meeting the primary endpoint for dose response, the consistent evidence supports advancing diranersen to confirmatory Phase 3 development. The therapy was generally well tolerated and previously received FDA Fast Track designation.

Biogen Inc. and Eisai Co., Ltd. announced that the U.S. FDA has approved a supplemental Biologics License Application for LEQEMBI IQLIK (lecanemab-irmb), a once-weekly subcutaneous injection for the initiation dose in early Alzheimer's disease. This approval introduces a convenient at-home dosing option via an autoinjector, offering flexibility for patients and care partners. The U.S. launch of the initiation dose is anticipated in late August 2026.

Eisai Co., Ltd. and Biogen Inc. announced new data at AAIC 2026, demonstrating that the LEQEMBI (lecanemab) subcutaneous autoinjector (SC-AI) formulation offers comparable efficacy and safety to intravenous (IV) administration for people with early Alzheimer’s disease. The data showed that once-weekly 500 mg SC-AI achieved drug exposure similar to the approved IV regimen, supporting similar clinical efficacy and safety. This subcutaneous option provides a convenient at-home alternative, potentially improving access and long-term disease management, with high patient and care partner satisfaction.

Biogen Inc. expects to incur significant acquired in-process research and development, upfront, and milestone expenses for the second and third quarters of 2026. For Q2 2026, a pre-tax charge of approximately $164 million is anticipated, impacting diluted EPS by about $0.95. For Q3 2026, expenses are projected to range from $290 million to $320 million, with an estimated diluted EPS impact of $1.75 to $1.95. These figures are preliminary and subject to change as the company does not typically forecast such uncertain expenses.

Biogen announced it will present new data from its Alzheimer's disease portfolio at the Alzheimer's Association International Conference (AAIC) 2026. Key presentations will include clinical, biomarker, and safety results from the Phase 2 CELIA study for diranersen, an investigational tau-targeting ASO, which is advancing towards Phase 3 development. Additionally, new data on LEQEMBI (lecanemab) will be presented, focusing on subcutaneous administration, real-world use, and three-year LEADER study results. The company emphasized its continued commitment to innovation in Alzheimer's care.

Biogen Inc. announced a definitive agreement to acquire RayThera Inc., a private biotechnology company focused on immunology, for up to $1 billion. The deal comprises an upfront payment and predominantly payments contingent on future clinical and regulatory milestones. This acquisition is set to deepen Biogen's immunology pipeline and expand into new disease areas, with RayThera's lead candidate expected to enter Phase 1 development in early Q3 2026. The transaction is subject to customary closing conditions and is anticipated to close in the third quarter of 2026.

Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has granted salanersen Breakthrough Therapy Designation for the treatment of spinal muscular atrophy (SMA). This designation aims to expedite the development and review of the investigational once-yearly antisense oligonucleotide (ASO), which has shown potential for high efficacy. The decision is based on Phase 1b study data, where children with SMA previously treated with gene therapy experienced clinically meaningful improvements in motor function and slowing of neurodegeneration after initiating salanersen. The company is advancing salanersen into three global Phase 3 studies.

UCB and Biogen Inc. announced positive data from the Phase 3 PHOENYCS GO study for dapirolizumab pegol (DZP) in systemic lupus erythematosus (SLE) at the EULAR 2026 Congress. The results showed that DZP, combined with standard of care, was associated with sustained disease control at lower glucocorticoid doses through Week 48, supporting reduced long-term steroid exposure. Additionally, improvements in immunological markers and reduced flare rates were observed, highlighting DZP's potential to address the complex burden of SLE.

Biogen announced that 14 abstracts highlighting data from its nephrology portfolio, including EMPAVELI (pegcetacoplan) and investigational felzartamab, have been accepted for presentation at the 63rd European Renal Association Congress (ERA) and the 2026 American Transplant Congress (ATC). The presentations will showcase sustained efficacy and safety of EMPAVELI in C3G/IC-MPGN from the VALIANT/VALE studies and additional analyses of felzartamab in antibody-mediated rejection (AMR). This highlights the momentum of Biogen's broadened nephrology portfolio.