Submit cytisinicline New Drug Application to FDA
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
- 10 Feb 2025
- Due
- 30 Jun 2025
- Delivered
- 26 Jun 2025
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Achieve remains on track with our expected NDA submission next quarter for cytisinicline”
What we found
Evidence strength B What the grades mean
Achieve Life Sciences submitted the cytisinicline NDA to the FDA on June 26, 2025, within the stated Q2 2025 (by June 30, 2025) deadline.
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B Achieve Life Sciences Reports Second Quarter 2025 Financial Results Confirms NDA submission met target milestone in June 2025.
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B Achieve Life Sciences Announces Submission of NDA to FDA for Cytisinicline Company press release announcing NDA submission on June 26, 2025.
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B Achieve Life Sciences 10-K Annual Report 10-K confirms NDA submitted in June 2025 and FDA accepted for review.
Checked 16 Sep 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
- Language
- Expected (“expects”, “plans”)
How this entry was checked
- Commitment recordedRecorded from the company's filing.
- First checkAn AI model 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-2025-ACHV-000409 · Corrections policy