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First U.S. Commercial Sale of KOMZIFTI™ Triggers $135 Million Milestone Payment to Kura Oncology Under Collaboration and License Agreement with Kyowa Kirin

Key Takeaway: Kura Oncology announced the successful completion of the first U.S. commercial sale of KOMZIFTI, triggering a $135 million milestone payment from Kyowa Kirin. The drug, approved by the FDA for treating relapsed or refractory NPM1-mutated acute myeloid leukemia, represents a significant advancement in Kura's pipeline. The payment is expected to be received before year-end 2025.
Price reaction · baseline $11.44 (2025-12-01 close) · hit pre-market · 1 other KURA headline(s) in the window, move may be shared
day 0 close · peak
-2.7%

Market Sentiment Analysis

POSITIVE FACTORS

  • First U.S. commercial sale of KOMZIFTI completed successfully.
  • $135 million milestone payment expected from Kyowa Kirin.
  • KOMZIFTI is FDA-approved for treating specific leukemia cases.

CONCERNS & RISKS

  • Risks associated with Kyowa Kirin's ability to make the payment.
  • Potential commercialization challenges for KOMZIFTI.
  • Uncertainties in the collaboration's future success.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+116%
120-day peak, hindsight
Typical move
5.7%
average across 9 past catalysts
Cash runway
~25 mo
Low dilution risk
Lead asset
Tipifarnib
Phase 2 · Leukemia, Myelomonocytic, Chronic

Full Press Release Details

SAN DIEGO, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”), a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced the first U.S. commercial sale of KOMZIFTI™ (ziftomenib) has been completed. Under Kura’s collaboration and license agreement with Kyowa Kirin Co. Ltd. and Kyowa Kirin, Inc. (collectively, “Kyowa Kirin”), this milestone triggers a $135 million payment from Kyowa Kirin to Kura, which Kura expects to receive prior to year-end. KOMZIFTI was approved by the U.S. Food and Drug Administration on November 13, 2025.
About Kura OncologyKura Oncology is a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Kura’s pipeline of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura developed and is commercializing KOMZIFTI™, the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractoryNPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. For additional information, please visit the Kura website athttps://kuraoncology.com/and follow us onXandLinkedIn.
Forward-Looking StatementsThis news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, Kura’s expectations regarding the receipt and timing of a milestone payment under its collaboration and license agreement with Kyowa Kirin and future development matters. Factors that may cause actual results to differ materially include risks related to Kyowa Kirin’s ability to make the expected milestone payment, including on the anticipated timing; risks associated with the commercialization of KOMZIFTI; the risk that the collaboration with Kyowa Kirin is unsuccessful; and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties Kura faces, please refer to Kura's periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Kura Contact

Frequently Asked Questions

What is KOMZIFTI?

KOMZIFTI (ziftomenib) is an FDA-approved oral menin inhibitor for adults with relapsed or refractory NPM1-mutated acute myeloid leukemia.

How much is the milestone payment from Kyowa Kirin?

The milestone payment from Kyowa Kirin to Kura Oncology is $135 million.

When was KOMZIFTI approved by the FDA?

KOMZIFTI was approved by the FDA on November 13, 2025.

What are the risks mentioned in the announcement?

Risks include Kyowa Kirin's ability to make the payment and potential commercialization challenges for KOMZIFTI.

Last updated: Dec 2, 2025