Catalyst overview
Research summary
This catalyst tracks a Approved update for Leqembi (Lecanemab) SC formulation in Alzheimer's disease. The expected timing is based on the latest available company guidance and may change.
Approved 8/29/25. Collab w/ Eisai. SC formulation. 5/15/24- Initiates Rolling BLA. 10/31/24- Completes rolling submission to FDA. 11/15/24- Receives positive opinion from CHMP. 1/13/25- BLA accepted with PDUFA action date set for August 31, 2025. 7/30/25- New data presented at AAIC. 8/29/25- FDA approval. 9/3/25- Rolling sBLA initiated for Early AD. 01/25/26:- FDA accepted sBLA for LEQEMBI IQLIK SC starting dose; PDUFA action date May 24, 2026. 05/08/26:- PDUFA date for Leqembi Iqlik starting-dose sBLA extended to August 24, 2026. 06/29/26:- AAIC July 12 session covers SC lecanemab at-home use; PDUFA still August 24, 2026. 07/12/26:- AAIC 2026 showed SC-AI bioequivalent to IV initiation; real-world series suggested sustained benefit. 07/14/26:- LEADER: SC maintenance 85.7% maintained stage. FDA approved SC autoinjector initiation dosing July 13, 2026.
Verification
Confirm timing and program details against the company announcement or filing.