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Axsome Therapeutics, Inc.

Submit the NDA for AXS-07 for the acute treatment of migraine

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
1 Mar 2021
Due
30 Jun 2021
Delivered
June 2021
  • Deadline
  • Met
  • Late
  • Not met
  • Today

What the company said

“Submission of this NDA is expected in early second quarter.”

What we found

Evidence strength A What the grades mean

The Q2 2021 10-Q says the AXS-07 NDA was submitted in June 2021, within the stated early-Q2 window. Later filings confirm it was accepted with a PDUFA date.

  • A
    Axsome Therapeutics, Inc. 10-Q filed 2021-11-08 Regulatory filing · published 8 Nov 2021 · retrieved 26 Oct 2026 · kept permanently by the SEC
    “An NDA has been submitted and accepted for filing for AXS-07 for the acute treatment of migraine.” ✓ confirmed on the page
  • A
    Axsome Therapeutics, Inc. 10-Q filed 2021-08-09 Regulatory filing · published 9 Aug 2021 · retrieved 26 Oct 2026 · kept permanently by the SEC
    “In June 2021, we submitted an NDA for filing for AXS-07 for the acute treatment of migraine.” ✓ confirmed on the page

Checked 26 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
NDA submission for AXS-07 in acute migraine
Language
Expected (“expects”, “plans”)
In the company’s control
High
Specificity
High

How this entry was checked

  1. Commitment recordedThe company's words were matched word for word against the filing.
  2. First checkAn AI model, Claude (Anthropic), read the company's later filings and recorded the outcome with a quoted passage.

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-AXSM-024905 · Corrections policy

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