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Kura Oncology Gains FDA Approval for KOMZIFTITM

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Kura Oncology Gains FDA Approval for KOMZIFTITM

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Kura Oncology ( (KURA) ) just unveiled an announcement.

On November 13, 2025, Kura Oncology and Kyowa Kirin announced the FDA’s full approval of KOMZIFTITM (ziftomenib) for adult patients with relapsed or refractory acute myeloid leukemia with an NPM1 mutation. This approval marks a significant advancement as KOMZIFTI is the first oral menin inhibitor for this type of AML, addressing a critical need for effective treatments. The approval is based on the KOMET-001 trial, which demonstrated a complete remission rate of 21.4% in patients. The strategic collaboration between Kura Oncology and Kyowa Kirin, established in November 2024, positions the companies to leverage their combined expertise in hematologic malignancies for the development and commercialization of KOMZIFTI, with Kura leading efforts in the U.S. and Kyowa Kirin outside the U.S.

The most recent analyst rating on (KURA) stock is a Buy with a $29.00 price target. To see the full list of analyst forecasts on Kura Oncology stock, see the KURA Stock Forecast page.

Spark’s Take on KURA Stock

According to Spark, TipRanks’ AI Analyst, KURA is a Neutral.

Kura Oncology faces challenges typical of biotech firms in transition, with positive revenue growth yet struggling profitability. Significant milestones in drug applications and a strong cash position are positive, but technical indicators and valuation metrics present caution. The company’s stock performance reflects these mixed factors.

To see Spark’s full report on KURA stock, click here.

More about Kura Oncology

Kura Oncology, Inc. operates in the biopharmaceutical industry, focusing on developing precision medicines for the treatment of cancer. The company is known for its work on targeted therapies, particularly in the area of hematologic malignancies, and collaborates with Kyowa Kirin Co., Ltd. to enhance its market reach.

Average Trading Volume: 1,910,094

Technical Sentiment Signal: Sell

Current Market Cap: $929.3M

See more data about KURA stock on TipRanks’ Stock Analysis page.

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