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Kyowa Kirin's $330M upfront bet on Kura Oncology's ziftomenib turned into a fast validated win: FDA granted full approval of KOMZIFTI for relapsed/refractory disease in November 2025, just a year after the up-to-$1.491B deal was signed.
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Full analysis, sources & comparables →Kura Oncology is bringing Kyowa Kirin on board as a global development and commercialization partner for ziftomenib, a Phase 3 selective menin inhibitor…
Kura Oncology has signed a global collaboration with Kyowa Kirin worth up to $1.5 billion for ziftomenib, its lead menin inhibitor in Phase 3 development for…
FDA granted full approval of KOMZIFTI (ziftomenib) for adults with R/R NPM1-mutant AML; approval triggers a $135M milestone payment from Kyowa Kirin to Kura.
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Kura Oncology (Nasdaq: KURA) and Kyowa Kirin (TSE: 4151) entered a global strategic collaboration and license agreement for ziftomenib, Kura's selective oral menin inhibitor (menin-KMT2A/MLL), announced November 20, 2024 and effective December 2024. Kura received a $330M upfront (held in cash as of 12/31/24) and is eligible for up to $420M in near-term milestones, up to $513M in additional development/regulatory/commercial milestones in hematologic malignancies, and $228M if Kyowa Kirin exercises the Field Expansion Option -- up to $1.491B in aggregate. In the U.S. Kura leads commercialization under a 50/50 profit/loss share; Kyowa Kirin leads ex-U.S. and pays tiered royalties. The asset advanced rapidly post-deal: the FDA granted Priority Review of the ziftomenib NDA in June 2025, and on November 13, 2025 granted full approval of KOMZIFTI (ziftomenib) for adults with relapsed/refractory NPM1-mutant AML -- the first and only once-daily oral menin inhibitor approved in this setting (pivotal KO-MEN-001 / NCT04067336: CR+CRh 21.4% in 112 patients; 600 mg once daily). The approval triggered a $135M milestone payment from Kyowa Kirin to Kura.
20K US cases/yr · $2.5B US AML Therapeutics Market
Acute myeloid leukemia (AML) is a heterogeneous hematologic malignancy of myeloid progenitors with approximately 20,000 new US cases and 11,000 deaths annually. NPM1 mutations occur in ~30% of adult AML and confer favorable prognosis at diagnosis but are associated with poor outcomes in relapsed/refractory disease; KMT2A rearrangements (formerly MLL) occur in ~5-10% of AML (higher in pediatric and therapy-related disease) with aggressive biology and historically dismal outcomes. Both subsets share a dependency on the menin-KMT2A (MLL1) protein-protein interaction, which sustains aberrant HOXA and MEIS1 transcriptional programs essential for leukemic stem cell maintenance. Standard induction (7+3 cytarabine/anthracycline) and consolidation, hypomethylating agent plus venetoclax regimens, FLT3 inhibitors (midostaurin, gilteritinib, quizartinib), IDH1/2 inhibitors (ivosidenib/Tibsovo, enasidenib/Idhifa, olutasidenib/Rezlidhia), and allogeneic HSCT define current care. Relapsed/refractory disease after two or more lines has overall survival measured in months, with CR rates to salvage chemotherapy of 10-20%. The menin inhibitor class offers a biomarker-directed approach for NPM1m and KMT2A-r AML, validated by FDA approval of revumenib (Revuforj, Syndax) in November 2024 for r/r KMT2A-rearranged acute leukemia and by ziftomenib's Breakthrough Therapy designation.
The AML competitive landscape is mechanism- and biomarker-stratified across multiple approved and development-stage drug classes. Menin inhibitors for NPM1m and KMT2A-r: Revuforj (revumenib, Syndax/Incyte, approved November 2024 for r/r KMT2A-r acute leukemia), ziftomenib (KO-539, Kura Oncology/Kyowa Kirin, Phase 3 KOMET-007/008 with BTD for NPM1m), bleximenib (JNJ-75276617, Johnson & Johnson), enzomenib (DSP-5336, Sumitomo), BMF-219 covalent menin inhibitor (Biomea Fusion), DS-1594 (Daiichi Sankyo). FLT3 inhibitors: Rydapt (midostaurin, Novartis), Xospata (gilteritinib, Astellas), Vanflyta (quizartinib, Daiichi Sankyo). IDH1/2 inhibitors: Tibsovo (ivosidenib, Servier), Idhifa (enasidenib, Bristol Myers Squibb), Rezlidhia (olutasidenib, Rigel). BCL2: Venclexta (venetoclax, AbbVie/Genentech) in combination with azacitidine/decitabine. Hypomethylating agents: Vidaza (azacitidine, Bristol Myers Squibb), Dacogen (decitabine, Otsuka), Inqovi (oral decitabine/cedazuridine, Taiho/Astex). CD33 ADC: Mylotarg (gemtuzumab ozogamicin, Pfizer). CD123: Tagraxofusp (Elzonris, Stemline/Menarini). TIM-3: sabatolimab (Novartis, discontinued). Magrolimab (anti-CD47, Gilead) was discontinued in 2024 after Phase 3 failures. The menin class is poised to become a meaningful commercial category by 2026-2028.
Kura/Kyowa Kirin agreement became effective December 2024; the $330M upfront was held in Kura's cash, cash equivalents and short-term investments as of 12/31/2024.
FDA accepted the ziftomenib NDA and granted Priority Review for adults with relapsed/refractory NPM1-mutant AML.
FDA granted full approval of KOMZIFTI (ziftomenib) -- the first and only once-daily oral menin inhibitor for R/R NPM1-mutant AML. Pivotal KO-MEN-001 (NCT04067336): CR+CRh 21.4% in 112 patients.
The KOMZIFTI FDA approval triggered a $135M milestone payment from Kyowa Kirin to Kura under the collaboration and license agreement, expected before year-end 2025.
| Deal | Year | Value | Outcome |
|---|---|---|---|
| Kyowa Kirin Co. Ltd. / Kura Oncology Inc. (this deal) | 2024 | $1.5B | — |
| Amgen Inc. / Micromet Inc. | 2012 | $1.2B | 88 |
| Servier / Shire plc (Oncology Business) | 2018 | $2.4B | 88 |
| AstraZeneca PLC / Alexion Pharmaceuticals Inc. | 2020 | $39.0B | 86 |
| Swedish Orphan Biovitrum AB / Biovitrum | 2001 | $493M | 84 |
| Otsuka Pharmaceutical Co. Ltd. / Astex Pharmaceuticals | 2013 | $886M | 79 |
| AbbVie Inc. / Pharmacyclics Inc. | 2015 | $21.0B | 79 |
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