Biogen Inc. (NASDAQ:BIIB) shares are trading higher on Friday as the company is continuing its FDA review process for Leqembi Iqlik (once‑weekly lecanemab‑irmb subcutaneous injection) for early Alzheimer’s disease.

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Biogen Leqembi Iqlik FDA Review Update

The FDA has extended the review period for Biogen’s supplemental Biologics License Application for Leqembi Iqlik by three months, pushing the new action date to Aug. 24, 2026.

The extension allows the agency to fully assess additional information submitted by Biogen and its partner Eisai, who believe the clinical data support the treatment’s potential.

Leqembi is indicated for Alzheimer’s disease (AD). Treatment with Leqembi should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.