Submit for full FDA approval for lecanemab
Delivered by the deadline
AI-confirmed · human review in progress Independent AI checks agreed on primary SEC or regulator evidence. Records are now being reviewed by hand, starting with those our customers order.
- Announced
- 3 May 2022
- Due
- 31 Mar 2023
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Biogen and Eisai plan to submit for full FDA approval by the first quarter of 2023.”
What we found
Evidence strength A What the grades mean
A later 10-Q says the supplemental BLA for traditional approval was submitted in January 2023, before the March 31, 2023 deadline.
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A Biogen 10-Q filed 2023-04-25
“in January 2023 we and Eisai announced the completed submission of a supplemental BLA to the FDA for traditional approval of LEQEMBI” ✓ confirmed on the page
Market reaction: the shares moved +0.3% against the S&P 500 over the three sessions around the disclosure (24 Apr 2023 to 27 Apr 2023). What this measures
Checked 10 Oct 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Regulatory other
- Indicative materiality
- Medium rules
- Action
- Submit
- Deliverable
- lecanemab full FDA approval submission
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- High
- Specificity
- High
- Conditional
- Yes: Based on the results of the Clarity AD study
- Depends on
- Partner
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- First checkAn AI model, Claude (Anthropic), read the company's later filings and recorded the outcome with a quoted passage.
- Second check: agreesA different AI model, Gemini (Google), re-read the evidence without being told the outcome and reached the same answer.
Confirmed. This outcome counts towards the company's Kept Score. How verification works
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Report an error in this entry Reference: KI-C-2022-BIIB-005347 · Corrections policy