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AUG 24 2026
EXTENDED · 82 DAYS TO PDUFA

Biogen Leqembi Iqlik (lecanemab-irmb (subcutaneous autoinjector)) $BIIB

for early Alzheimer's disease (subcutaneous maintenance dosing)

sBLA · Standard Review

Originally MAY 24 2026; extended to AUG 24 2026 (FDA major-amendment extension (3 months), announced MAR 15 2026).

About

Alzheimer's disease is a progressive brain disorder that impairs memory and cognitive function, eventually leading to loss of independence and bodily control. Leqembi Iqlik is a self-administered antibody injection that targets and clears abnormal protein clumps (amyloid protofibrils) in the brain. By removing these toxic proteins early in the disease, the treatment may help slow cognitive decline and preserve daily functioning longer.

PDUFA history

  • MAY 24 2026 shifted to AUG 24 2026 (FDA major-amendment extension (3 months); announced MAR 15 2026)