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Biogen advances anti-tau Alzheimer’s drug diranersen despite mixed Phase 2 results

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Biogen reported mixed topline results from the Phase 2 CELIA study of diranersen (BIIB080), an antisense oligonucleotide designed to reduce tau production in early Alzheimer’s disease. The trial missed its primary endpoint for dose-response, but prespecified analyses showed slowing of cognitive decline across doses, with the strongest signal at the lowest dose. Diranersen also reduced tau levels and tau pathology in cerebrospinal fluid and the brain, which Biogen described as supporting the efficacy signal. Despite the missed endpoint, Biogen said it plans to advance diranersen into registrational development / pivotal testing. The drug’s safety and tolerability were reported as generally consistent with earlier studies, and more detailed data are expected at upcoming scientific meetings such as AAIC 2026. Sources:

Mochida Pharmaceutical: Notice Concerning Changes in Directors

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Tempus Expands Strategic Collaboration with Bristol Myers Squibb to Use AI and Real‑World Data to Improve Clinical Trial Success

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Datar Cancer Genetics Announces US FDA Clearance for CellDx-Tissue

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Bora snaps up MacroGenics' manufacturing, CDMO operations for up to $127.5M

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BeOne's Beqalzi wins FDA accelerated approval as first BCL-2 inhibitor for mantle cell lymphoma

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Create Medicines raises $122M to advance in vivo CAR-T programs

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Biogen advances Alzheimer’s tau program despite midphase miss

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Valneva to cut up to 15% of jobs as reduced travel hits vaccine demand

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Recent developments in transforming oversight and risk management in pharma R&D

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28bio Launches CNS-3D Myelinated Organoids to Predict Therapeutic Efficacy

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Regenxbio's RGX-202 Duchenne Gene Therapy Shows Positive Interim Data, Pivotal Results Expected Q2 2026 for FDA Accelerated Approval

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Infinimmune Appoints Srikanth Pendyala, M.D., as Chief Medical Officer

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