Submit the aflibercept 8 mg Biologics License Application for DME and wet AMD
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 Nov 2022
- Due
- 31 Dec 2022
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“The Company intends to use a priority review voucher in connection with the submission of the aflibercept 8 mg Biologics License Application (BLA) for DME and wet AMD, which is currently planned for late 2022.”
What we found
Evidence strength A What the grades mean
Later filings state the aflibercept 8 mg BLA for wet AMD and DME was submitted in December 2022, within the late 2022 window; no exact day is given.
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A Regeneron Pharmaceuticals 8-K filed 2023-02-03
“A Biologics License Application (BLA) for the treatment of wet AMD and DME was submitted to the U.S. Food and Drug Administration (FDA) in December 2022.” ✓ confirmed on the page
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A Regeneron Pharmaceuticals 8-K filed 2023-02-03
“In the fourth quarter of 2022, we submitted our Biologics License Application for neovascular age-related macular degeneration and diabetic macular edema for aflibercept 8 mg” ✓ confirmed on the page
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A Regeneron Pharmaceuticals 10-K filed 2023-02-06
“The Company is utilizing a priority review voucher in connection with the December 2022 submission of the BLA for DME and wet AMD.” ✓ confirmed on the page
Market reaction: the shares moved +2.9% against the S&P 500 over the three sessions around the disclosure (2 Feb 2023 to 7 Feb 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 submission
- Indicative materiality
- High rules
- Action
- Submit
- Deliverable
- Aflibercept 8 mg BLA for DME and wet AMD
- Where
- United States
- Language
- Aspirational (“aims”, “intends”)
- In the company’s control
- High
- Specificity
- Medium
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-REGN-006342 · Corrections policy