Kura Oncology’s FDA Priority Review for Ziftomenib

An update from Kura Oncology ( (KURA) ) is now available.

On June 1, 2025, Kura Oncology and Kyowa Kirin announced that the FDA accepted their New Drug Application for ziftomenib, targeting relapsed or refractory acute myeloid leukemia with an NPM1 mutation. The application, based on positive results from the Phase 2 KOMET-001 trial, received Priority Review with a target action date of November 30, 2025. The trial demonstrated a 23% complete remission rate among heavily pretreated patients, with a median overall survival of 16.4 months for responders. The safety profile was consistent with previous data, showing manageable treatment-related adverse events.

The most recent analyst rating on (KURA) stock is a Buy with a $32.00 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 is a company in the biopharmaceutical industry, focusing on developing innovative therapies for cancer treatment. Its primary product is ziftomenib, an investigational menin inhibitor aimed at treating acute myeloid leukemia (AML), particularly in cases with relapsed or refractory conditions.

Average Trading Volume: 1,305,675

Technical Sentiment Signal: Sell

Current Market Cap: $545.4M

For a thorough assessment of KURA stock, go to TipRanks’ Stock Analysis page.