secwatch.observer — SEC 8-K summary
======================================

Issuer:     Kura Oncology, Inc. (KURA)
CIK:        0001422143
Form:       8-K
Filed at:   2025-06-03T23:59:59+00:00
Accession:  0001193125-25-133717
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1422143/000119312525133717/0001193125-25-133717-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1422143/000119312525133717/d917067d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-133717

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer