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

Issuer:     Kura Oncology, Inc. (KURA)
CIK:        0001422143
Form:       8-K
Filed at:   2025-11-13T23:59:59+00:00
Accession:  0001193125-25-280255
Event type: regulatory
Sentiment:  positive
Materiality: 0.90
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud

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

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1422143/000119312525280255/0001193125-25-280255-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1422143/000119312525280255/d159173d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-280255

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