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# Ziftomenib NDA Due in 2nd Quarter: Kura/Kyowa
- URL: https://www.fdaweb.com/ziftomenib-nda-due-in-2nd-quarter-kura-kyowa/
- Published: 2025-02-05T12:00:00.000Z
- Updated: 2026-09-14T14:52:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158607

Kura Oncology and Kyowa Kurin say they are on track to submit a second-quarter NDA for ziftomenib, described as a highly selective once-daily oral investigational menin inhibitor indicated to treat patients with relapsed/refractory NPM1-mutant acute myeloid leukemia (AML). A Kura [statement](https://ir.kuraoncology.com/news-releases/news-release-details/kura-oncology-and-kyowa-kirin-announce-positive-ziftomenib?ref=fdaweb.com) reports positive results from the KOMET-001 Phase 2 registrational trial of ziftomenib.

The statement also cites FDA positive comments on the proposed KOMET-017 trial evaluating ziftomenib in combination with standard of care in adults with newly diagnosed NPM1-mutant or KMT2A-rearranged AML.