Kura Oncology (KURA) Is Up 8.1% After FDA Clears First Targeted Therapy for NPM1-Mutated AML

• On November 13, 2025, Kura Oncology and Kyowa Kirin announced that the FDA had granted full approval for KOMZIFTI (ziftomenib), the first once-daily targeted therapy for adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, following positive results from the pivotal KOMET-001 trial.
• This approval addresses a significant unmet need in a patient group where around 30% of AML cases involve NPM1 mutations and treatment options have historically been limited.
• We'll examine how FDA approval of KOMZIFTI as the first targeted therapy for NPM1-mutated AML transforms Kura Oncology’s investment outlook.

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Kura Oncology Investment Narrative Recap

To believe in Kura Oncology as a shareholder today, you need to have confidence in its ability to execute a successful commercial launch for KOMZIFTI, its newly FDA-approved therapy for NPM1-mutated AML, and translate that approval into meaningful and sustainable revenue growth. The full approval does strengthen the near-term catalyst of a first commercial oncology product, but the company’s key risk, managing cash burn and remaining unprofitable as expenses mount, remains in focus, especially if market uptake is slower than anticipated.

Among the recent announcements, the initiation and advancement of the pivotal Phase III KOMET-017 trial is particularly relevant. Successful progress there, highlighted by recent milestone payments from Kyowa Kirin, underpins Kura's longer-term path to expanding the addressable market beyond relapsed/refractory AML and delivering on the growth prospects that now depend heavily on post-approval execution.

In contrast, investors should be aware that Kura’s accelerating net losses and cash usage could still present funding pressures if...

Read the full narrative on Kura Oncology (it's free!)

Kura Oncology's narrative projects $434.8 million in revenue and $69.8 million in earnings by 2028. This requires 73.5% yearly revenue growth and a $267 million increase in earnings from current earnings of -$197.2 million.

Uncover how Kura Oncology's forecasts yield a $31.80 fair value, a 171% upside to its current price.

Exploring Other Perspectives

Simply Wall St Community participants provided just one fair value estimate at US$31.80, suggesting limited diversity among retail investor opinions so far. Given Kura’s clinical and market execution risks, readers should compare this view with broader market implications and consider exploring the range of perspectives that exist.

Explore another fair value estimate on Kura Oncology - why the stock might be worth just $31.80!

Build Your Own Kura Oncology Narrative

Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

• A great starting point for your Kura Oncology research is our analysis highlighting 1 key reward and 2 important warning signs that could impact your investment decision.
• Our free Kura Oncology research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Kura Oncology's overall financial health at a glance.

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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