Submit NDA for ziftomenib in relapsed/refractory NPM1-mutated AML
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
- 5 Feb 2025
- Due
- 30 Jun 2025
- Delivered
- 31 Mar 2025
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“NDA submission for ziftomenib on track for 2Q 2025”
What we found
Evidence strength A What the grades mean
Kura Oncology submitted the ziftomenib NDA to the FDA on March 31, 2025, ahead of the stated 2Q 2025 target, and FDA later accepted it with Priority Review.
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A Kura Oncology, Inc. - Form 10-Q - FY2025 10-Q confirms NDA submission date of March 31, 2025 and subsequent FDA acceptance
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B Kura Oncology and Kyowa Kirin Announce FDA Acceptance and Priority Review of New Drug Application for Ziftomenib FDA accepted NDA with Priority Review, PDUFA date Nov 30, 2025
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B Kura Oncology and Kyowa Kirin Announce Submission of New Drug Application for Ziftomenib to FDA Confirms NDA submitted to FDA on March 31, 2025
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B Kura Oncology Reports First Quarter 2025 Financial Results States NDA submitted in 1Q 2025, earlier than 2Q guidance
Checked 12 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
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-KURA-000235 · Corrections policy