Complete the rolling submission of the New Drug Application for MDD
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 Dec 2022
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Biogen and Sage have initiated the rolling submission of a New Drug Application (NDA) to the U.S. FDA for MDD, which is expected to be complete in the second half of 2022.”
What we found
Evidence strength A What the grades mean
Later 10-K filings state that the rolling NDA submission for zuranolone in MDD was completed in December 2022, before the deadline.
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A Biogen 10-K filed 2023-02-15
“In December 2022 we and Sage completed the rolling submission of a New Drug Application (NDA) to the FDA for the approval of zuranolone for the potential treatment of MDD and PPD.” ✓ confirmed on the page
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A Biogen 10-K filed 2023-02-15
“In December 2022 we and Sage completed the rolling submission of a NDA to the FDA for the approval of zuranolone for the potential treatment of MDD and PPD.” ✓ confirmed on the page
Market reaction: the shares moved -2.4% against the S&P 500 over the three sessions around the disclosure (14 Feb 2023 to 17 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 other
- Indicative materiality
- Medium rules
- Action
- Complete
- Deliverable
- NDA rolling submission for MDD
- Where
- U.S.
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- High
- Specificity
- High
- 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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