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StocksUpdated•Originally published 8 May 2026•Updated 8 May 2026•

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FDA Delays Decision on Biogen and Eisai Subcutaneous Leqembi Until August 2026

Key Facts

1Biogen and Eisai announced a three-month FDA delay for the decision on the subcutaneous formulation of the Alzheimer’s drug Leqembi.

2The FDA set a new target action date of August 24 after requesting additional information deemed a major amendment.

Shares of Biogen (BIIB) rose despite the company and its partner Eisai announcing that the FDA has extended the review period for the subcutaneous formulation of the Alzheimer’s drug Leqembi. The agency has set a new target action date of August 24, 2026, following a request for additional data classified as a major amendment to the application. Amidst this delay, Biogen has strengthened its market position through the acquisition of Apellis Pharmaceuticals. Furthermore, the company recently received approval for a new high-dose regimen for its spinal muscular atrophy treatment, Spinraza. Analysts suggest these strategic corporate developments and portfolio expansions have bolstered investor confidence despite the regulatory timeline shift for Leqembi. Biogen remains committed to collaborating with regulators to bring this convenient administration option to market by the new deadline.

26 days ago

Version History

Version 126 days ago

What changed: Updated the FDA target date to 2026, included the rise in Biogen shares, the Apellis Pharmaceuticals acquisition, and the new Spinraza high-dose regimen approval.