---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-280255"
form_type: "8-K"
ticker: "KURA"
cik: "0001422143"
company_name: "Kura Oncology, Inc."
filed_at: "2025-11-13T23:59:59+00:00"
generated_at: "2026-05-16T20:18:27.016704+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Kura Oncology announces FDA full approval of KOMZIFTI for NPM1-mutated AML

## Summary
- FDA granted full approval of KOMZIFTI (ziftomenib) on November 13, 2025 for R/R NPM1-mutated AML patients with no satisfactory alternative.
- KOMZIFTI is the first and only once-daily oral menin inhibitor approved for this indication, with a CR+CRh rate of 21.4% in the KOMET-001 trial.
- Median duration of CR+CRh was 5.0 months; median time to first response was 2.7 months; 88% of responders achieved remission within 6 months.
- Kura Oncology set a wholesale acquisition cost of $48,500 per month; global collaboration with Kyowa Kirin oversees U.S. and ex-U.S. commercialization.
- Boxed Warning for differentiation syndrome included; no Grade 4 or 5 QTc prolongation reported in the pivotal study.

## SEC filing metadata
- accession: 0001193125-25-280255
- form_type: 8-K
- ticker: KURA
- cik: 0001422143
- company_name: Kura Oncology, Inc.
- filed_at: 2025-11-13T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1422143/000119312525280255/0001193125-25-280255-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1422143/000119312525280255/d159173d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-280255
- JSON: https://secwatch.observer/filing/0001193125-25-280255.json
- Plain text: https://secwatch.observer/filing/0001193125-25-280255.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.