Biogen Inc., BIIB, FDA Calendar, PDUFA Date

Company Name	Biogen Inc. BIIB
Drug Name	LEQEMBI IQLIK (sBLA)
Event Name	FDA decision on LEQEMBI IQLIK, as a weekly starting dose, for the treatment of early Alzheimer’s Disease
Event Date	05/24/2026
Outcome Date	05/08/2026
Outcome	FDA requests additional information during the review process of LEQEMBI IQLIK and extends decision by three months to Aug 24
Drug Status	Priority review LEQEMBI is the result of a strategic research alliance between Eisai and BioArctic Eisai leads the global development and regulatory filings of LEQEMBI, co-commercialises and co-promotes it with Biogen, and has final decision-making authority.
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Other Approvals	LEQEMBI IQLIK is a subcutaneous autoinjector, which is already indicated for maintenance dosing to treat Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD) in the U.S.
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