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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

Kura Oncology (Nasdaq: KURA) announced the first U.S. commercial sale of KOMZIFTI™ (ziftomenib).

(Moderate)

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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.

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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.
Argus Dec 2 session
-2.71% close to close 0.6x rel. volume Open Argus
Details

News Market Reaction – KURA

On Dec 2, the day this news came out, KURA closed 2.71% below the previous close.

Data tracked by StockTitan Argus for the Dec 2 session.

Key Figures

Milestone payment: $135 million Collaboration revenue: $20.8 million Net loss: $74.1 million +5 more
Milestone payment
$135 million
Triggered by first U.S. KOMZIFTI commercial sale under Kyowa Kirin collaboration
Collaboration revenue
$20.8 million
Q3 2025 revenue from Kyowa Kirin partnership
Net loss
$74.1 million
Q3 2025 net loss, $0.85 per share
Cash & investments
$549.7 million
Liquidity as of September 30, 2025
Deferred revenue
$317.6 million
Contract liabilities from collaboration as of September 30, 2025
Prior milestone
$30 million
Milestone from Kyowa Kirin on first patient dosed in KOMET‑017
WAC per month
$48,500
Wholesale acquisition cost for one‑month KOMZIFTI supply
KOMET‑001 size
112 patients
Pivotal trial supporting KOMZIFTI approval in R/R NPM1‑mutated AML

Historical Context

5 past events · Latest: Dec 08
5 events
  1. Dec 08

    Clinical data update

    24h Move
    -2.6%

    ASH 2025 combination data for KOMZIFTI showing strong activity and tolerability.

  2. Dec 03

    Investor event

    24h Move
    +7.5%

    Announcement of virtual event to discuss ASH 2025 triplet combination data.

  3. Dec 02

    Commercial milestone

    24h Move
    -2.7%

    First U.S. KOMZIFTI sale triggering $135 million payment from Kyowa Kirin.

  4. Nov 25

    Guideline inclusion

    24h Move
    +3.4%

    KOMZIFTI added as NCCN Category 2A option for NPM1-mutated AML.

  5. Nov 13

    FDA approval

    24h Move
    +0.0%

    FDA approval of KOMZIFTI for relapsed/refractory NPM1‑mutated AML.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

U.S. Food and Drug Administration
1 terms
U.S. Food and Drug Administration regulatory
"KOMZIFTI was approved by the U.S. Food and Drug Administration on November 13, 2025."
The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

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.

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