LEQEMBI IQLIK (lecanemab-irmb) subcutaneous autoinjector - weekly initiation dose
FDA PDUFA Target Action Date · Biogen Inc.
Note: ALREADY ACTIONED - add with outcome=approved, not as an upcoming catalyst. Biogen Q2 2026 10-Q (filed Jul 29, 2026): 'In May 2026 the FDA extended the review period by three months for the supplemental BLA for LEQEMBI subcutaneous autoinjector, LEQEMBI IQLIK, for a weekly initiation dose, with a new PDUFA action date of August 24, 2026; in July 2026 the FDA approved the supplemental BLA.' Approval is also cited in Biogen's Q2 2026 earnings release, 8-K Ex-99.1 filed Jul 29, 2026 ('LEQEMBI IQLIK ... approved by the FDA as an initiation dose'). Attribution caveat: the BLA is held by Eisai Co., Ltd.; Biogen is the 50/50 collaboration partner and is the SEC-filing source of the date.
Drug Information
- Drug Name
- LEQEMBI IQLIK (lecanemab-irmb) subcutaneous autoinjector - weekly initiation dose (CT.gov)
- Application Type
- sBLA
- Indication
- Early Alzheimer's disease (subcutaneous autoinjector initiation dosing)
Filing Details
- Company
- Biogen Inc. →
- Stock Ticker
- BIIB
- SEC CIK
- Source
- SEC 10-Q →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
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Data sourced from SEC EDGAR filings. Last updated: 2026-08-02. Report an issue