KURA: FDA Approval Will Drive Future Upside From New Leukemia Therapy

Analysts have nudged their price target on Kura Oncology slightly higher, from $29 to $30 per share, citing the FDA approval and rollout expectations for Komzifti as a key value driver.

Analyst Commentary

Analysts view the FDA approval of Komzifti as a pivotal inflection point for Kura Oncology, prompting upward revisions to valuation models and risk assumptions.

Bullish Takeaways

• Bullish analysts now assign a 100 percent probability of success to Komzifti in their models, effectively removing a major regulatory overhang and supporting a higher risk adjusted valuation.
• The characterization of Komzifti's approval as a watershed moment underpins expectations for a meaningful shift from a development stage narrative to a commercial growth story.
• Updated sales forecasts, even assuming only about one month of initial rollout, suggest early revenue contribution that can help de risk near term cash burn and support funding for broader pipeline execution.
• The modest increase in price target, despite a step change in perceived risk profile, implies further upside potential if launch metrics and market penetration exceed currently conservative assumptions.

Bearish Takeaways

• The incremental one dollar increase in price target indicates that some of the Komzifti approval upside had already been priced in, limiting near term re rating potential.
• Sales assumptions build in only a short initial rollout period, highlighting execution risk around launch readiness, physician adoption, and payer access that could impact early revenue trajectories.
• With Komzifti success now treated as certain in models, future valuation moves may be more sensitive to real world performance metrics and competitive dynamics, increasing downside risk if expectations are not met.

What's in the News

• Kura Oncology and Kyowa Kirin received full FDA approval for KOMZIFTI (ziftomenib) for adults with relapsed or refractory AML with susceptible NPM1 mutation, supported by pivotal KOMET-001 data showing a 21.4 percent CR/CRh rate and median response duration of 5 months (Company announcement).
• KOMZIFTI has been incorporated into the NCCN Clinical Practice Guidelines in Oncology as a Category 2A recommended option for adults with relapsed or refractory NPM1 mutated AML and is now commercially available in the United States through a limited network of specialty pharmacies and distributors (Company announcement).
• The first U.S. commercial sale of KOMZIFTI has been completed, triggering a 135 million dollar milestone payment from Kyowa Kirin to Kura, expected before year end (Company announcement).
• Kura received two 30 million dollar milestone payments tied to first patient dosing in the KOMET-017 Phase 3 registrational trials of ziftomenib, bringing total milestones received to 105 million dollars with up to 315 million dollars in additional near term milestones anticipated (Company announcement).
• New preliminary data from Kura's FTI programs, darlifarnib (KO-2806) and tipifarnib, presented at ESMO 2025, showed manageable safety and encouraging antitumor activity across advanced solid tumors and PIK3CA altered head and neck cancer, supporting further combination development (Company announcement).

Valuation Changes

• Fair Value has risen slightly, increasing from 31.8 dollars to 33.0 dollars per share. This reflects modestly higher long term expectations.
• Discount Rate has edged up from 7.01 percent to approximately 7.04 percent, implying a marginally higher required return and slightly higher perceived risk.
• Revenue Growth remains effectively unchanged at about 60.54 percent, indicating no material revision to top line expansion assumptions.
• Net Profit Margin has decreased modestly, moving from roughly 16.98 percent to 16.03 percent. This suggests slightly lower long term profitability expectations.
• Future P/E multiple has risen meaningfully, from about 56.5x to 62.2x, signaling a higher valuation being assigned to Kura Oncology's projected earnings stream.