By Fineline Cube 
Kura Oncology, Inc. (NASDAQ: KURA) announced completion of the first US commercial sale of KOMZIFTI (ziftomenib), triggering a USD 135 million milestone payment from Kyowa Kirin under their 2024 licensing agreement. Kura expects to receive payment prior to year‑end.
Commercial Milestone & Financial Impact
| Milestone | Details |
|---|---|
| Product | KOMZIFTI (ziftomenib) |
| Indication | Adults with relapsed or refractory NPM1‑mutated acute myeloid leukemia (AML) |
| FDA Approval | November 13, 2025 |
| First Commercial Sale | December 3, 2025 |
| Milestone Payment | USD 135 million from Kyowa Kirin |
| Total Deal Value | Up to USD 1.5 billion (including milestones and royalties) |
| Territory | Kyowa Kirin holds rights outside US; Kura retains US commercialization |
Product Profile & Mechanism
- Drug Class: Once‑daily oral menin inhibitor
- Target: NPM1‑mutated AML (accounts for ~30% of adult AML cases)
- Mechanism: Disrupts menin‑MLL interaction to reverse differentiation block in leukemic blasts
- Competitive Edge: First approved therapy specifically for NPM1‑mutated AML population
Market Opportunity & Strategic Outlook
| Market Parameter | Value/Insight |
|---|---|
| AML Incidence | ~20,000 new cases annually in US; NPM1 mutation in ~6,000 patients |
| Pricing | Estimated annual cost of $300,000‑400,000 per patient |
| Peak Sales Potential | Analysts project $500‑700 million US peak sales |
| Kyowa Kirin Strategy | Ex‑US launch planned for 2026‑2027 in Japan, Europe, and Asia‑Pacific |
| Revenue Impact | $135M payment strengthens Kura’s cash runway into 2027 |
Forward‑Looking Statements
This brief contains forward‑looking statements regarding milestone payment timing, market penetration, and revenue projections. Actual results may differ due to commercial execution, competitive, and regulatory risks.-Fineline Info & Tech