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FDA Calendar - BioArctic AB

Company Name	BioArctic AB BRCTF, BIOA-B.ST, BIOA_B.ST
Drug Name	Leqembi Iqlik subcutaneous autoinjector (sBLA)
Event Name	FDA decision on Leqembi Iqlik Subcutaneous Autoinjector for the treatment of Alzheimer’s disease in patients with Mild Cognitive Impairment or mild dementia stage of disease
Event Date	05/24/2026
Outcome Date
Outcome	pending
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.
Rival Drugs	If approved, Leqembi Iqlik would be the first and only anti-amyloid treatment to offer at-home injection options for initiation and maintenance dosing for the treatment of Alzheimer’s disease in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease
Market Potential
Other Approvals	EQEMBI 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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