Biogen (NASDAQ:BIIB) advances Alzheimer’s care with new dosing regimens and bioequivalent SC lecanemab, promising real‑world stability for most patients, mixed Phase 2 tau results that slowed decline yet missed primary endpoints, and Phase 3 and combo study plans alongside a virtual ataxia care partnership.
Previous Week Recap
- Biogen Dosing Approved: Biogen (BIIB) approved dosing: start two 250 mg injections weekly for adults with mild cognitive impairment or mild Alzheimer's; after 18 months switch to 360 mg weekly maintenance (IV or SC).
- Diranersen Shows Tau Reductions: Biogen’s diranersen Phase 2 showed up to 65% reductions in brain and CSF tau and a 26% slower cognitive decline in one analysis, missed its primary endpoint, and shares fell ~7%.
- Lecanemab Subcutaneous Bioequivalent: Biogen reports lecanemab subcutaneous 500 mg weekly autoinjector is bioequivalent to IV 10 mg/kg q2w; data show comparable efficacy and safety between SC and IV dosing.
- Phase 3 Planning For CELIA: Biogen (BIIB) starts Phase 3 planning, prepping an end-of-Phase 2 meeting, will publish more CELIA data, expects two-year CELIA results by end-2026, and readies combo and tau monotherapy studies
- LEADER Data: Stability Common: Biogen (BIIB) real-world LEADER data on lecanemab: after ~17 months, 75.9% of patients stayed in same disease stage, 6.6% improved; ~83% stable or improved overall.
- IV Maintenance Stable, ARIA Rates: Biogen (BIIB): IV every-4-week maintenance saw ~81% of patients stable or improved. Small SC subgroup largely maintained stage. ARIA events 12.3% overall (ARIA-E 6.3%, ARIA-H 7.9%), mostly mild.
- Biogen Partners With Synapticure: Biogen (BIIB) partners with Synapticure to back a new virtual ataxia care program offering nationwide specialized neurology access for adults; Biogen isn’t involved in clinical service delivery.
This is an AI-generated summary and may contain inaccuracies. Please verify any important information with the original sources.