Submit filing for zuranolone for postpartum depression
Delivered by the deadline
AI-assessed · human review in progress Found and assessed by AI from the cited sources. Shown with its evidence; it is not counted in any Kept Score until confirmed.
- Announced
- 20 Oct 2021
- Due
- 30 Jun 2023
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“an additional filing for postpartum depression (PPD) is anticipated in the first half of 2023”
What we found
Evidence strength A What the grades mean
The FDA accepted the zuranolone NDA and granted Priority Review in February 2023, implying the filing was submitted before the June 2023 deadline.
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A Biogen 10-Q filed 2023-07-25
“In February 2023 the FDA accepted the NDA and granted Priority Review for zuranolone.” ✓ confirmed on the page
Market reaction: the shares moved -4.8% against the S&P 500 over the three sessions around the disclosure (24 Jul 2023 to 27 Jul 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 filing
- Indicative materiality
- Medium rules
- Action
- Submit
- Deliverable
- filing for zuranolone for postpartum depression
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- High
- Specificity
- High
- Depends on
- Regulatory
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: disagreesGemini (Google) re-read the evidence blind and read it as “no_evidence”.
- Tie-breakA stronger model read the evidence and both earlier answers, without knowing which was recorded, and agrees with the second check.
Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. How verification works
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Report an error in this entry Reference: KI-C-2021-BIIB-005343 · Corrections policy