---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-133717"
form_type: "8-K"
ticker: "KURA"
cik: "0001422143"
company_name: "Kura Oncology, Inc."
filed_at: "2025-06-03T23:59:59+00:00"
generated_at: "2026-05-20T01:16:47.803164+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Kura Oncology's NDA for ziftomenib accepted with Priority Review; Phase 2 shows 23% CR/CRh rate

## Summary
- FDA accepted NDA for ziftomenib in R/R NPM1-m AML; Priority Review set; PDUFA date Nov 30, 2025.
- Phase 2 KOMET-001: 23% (21/92) CR/CRh rate; median OS 16.4 months for responders, 3.5 months for non-responders.
- 63% of evaluable CR/CRh patients achieved MRD-negative; TRAEs led to discontinuation in 3% of patients.
- Ziftomenib previously received Breakthrough Therapy, Fast Track, and Orphan Drug designations; co-developed with Kyowa Kirin.

## SEC filing metadata
- accession: 0001193125-25-133717
- form_type: 8-K
- ticker: KURA
- cik: 0001422143
- company_name: Kura Oncology, Inc.
- filed_at: 2025-06-03T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1422143/000119312525133717/0001193125-25-133717-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1422143/000119312525133717/d917067d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-133717
- JSON: https://secwatch.observer/filing/0001193125-25-133717.json
- Plain text: https://secwatch.observer/filing/0001193125-25-133717.txt

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