• FDA extended PDUFA date for Leqembi Iqlik sBLA to Aug. 24 from May 24 after requesting additional information that it classified as a major amendment.
• Agency has not flagged concerns so far on approvability of Leqembi Iqlik as a starting dose, keeping focus on potential timing shift for U.S. label expansion.
• Update follows FDA clearance of subcutaneous maintenance dosing regimen on Aug. 26, 2025, with Eisai positioning subcutaneous data package to support initiation use pending review outcome.

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