File the New Drug Application for PPD
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
“with an associated NDA filing anticipated in early 2023.”
What we found
Evidence strength A What the grades mean
An April 2023 filing reports the zuranolone NDA, covering postpartum depression, was already accepted with a priority review and an August 2023 PDUFA date, implying submission before the deadline.
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A Biogen 8-K filed 2023-04-25
“Zuranolone New Drug Application for major depressive disorder and postpartum depression accepted in the U.S. and granted Priority Review; PDUFA date of August 5, 2023” ✓ 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 submission
- Indicative materiality
- High rules
- Action
- File
- Deliverable
- NDA filing for PPD
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- High
- Specificity
- Medium
- 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: 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 recorded outcome.
Confirmed. This outcome counts towards the company's Kept Score. How verification works
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