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

Rhea-AI Summary

Kura Oncology (Nasdaq: KURA) announced the first U.S. commercial sale of KOMZIFTI™ (ziftomenib). Under Kura's collaboration and license agreement with Kyowa Kirin, the sale triggers a $135 million milestone 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. This payment represents a near-term cash inflow tied to commercialization activity for the newly approved therapy.

Positive

• $135 million milestone payment expected prior to year-end
• FDA approval for KOMZIFTI on November 13, 2025
• First U.S. commercial sale confirms product market entry

Negative

• None.

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 Oncology
Kura 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 refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. For additional information, please visit the Kura website at https://kuraoncology.com/ and follow us on X and LinkedIn.

Forward-Looking Statements 
This 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

Investors and Media:
Greg Mann
858-987-4046
gmann@kuraoncology.com

FAQ

What triggered the $135 million milestone payment to Kura (KURA)?

The first U.S. commercial sale of KOMZIFTI under the Kyowa Kirin collaboration triggered the $135 million payment.

When does Kura expect to receive the $135 million payment for KOMZIFTI (KURA)?

Kura expects to receive the $135 million payment from Kyowa Kirin prior to year-end.

When was KOMZIFTI (ziftomenib) approved by the FDA for U.S. use?

KOMZIFTI received U.S. FDA approval on November 13, 2025.

How does the KOMZIFTI commercial sale affect Kura Oncology shareholders (KURA)?

The sale triggered a $135 million milestone payment, providing a near-term cash inflow tied to product commercialization.

Does the announcement confirm KOMZIFTI is being sold in the U.S. now for KURA investors?

Yes. The company announced the first U.S. commercial sale of KOMZIFTI, indicating market launch activity.

Who is responsible for the $135 million milestone payment to Kura (KURA)?

The payment is from Kyowa Kirin under the collaboration and license agreement with Kura.