Kura Oncology

KURA

Market cap $969M

Kura Oncology remains a Strong Buy, driven by Ziftomenib's differentiated safety profile and significant AML market potential. KURA's Ziftomenib avoids a QTc prolongation boxed warning, offering a potential safety edge over Syndax's Revuforj despite similar efficacy in R/R NPM1-mutated AML. Upcoming Phase 1b KOMET-007 data at ASH could shift market sentiment, with volatility expected as efficacy is compared to Syndax's robust results.

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.

KOMZIFTI, the first and only once-daily FDA-approved menin inhibitor for R/R NPM1-mutated AML, is now commercially available in the United States KOMZIFTI, the first and only once-daily FDA-approved menin inhibitor for R/R NPM1-mutated AML, is now commercially available in the United States

Kura Oncology, Inc. ( KURA ) Discusses FDA Approval of KOMZIFTI for Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia November 13, 2025 12:30 PM EST Company Participants Greg Mann Troy Wilson - Chairman, CEO & President Mollie Leoni - Chief Medical Officer Brian Powl - Chief Commercial Officer Conference Call Participants Eunice Wang Daniel Bronder Jonathan Chang - Leerink Partners LLC, Research Division Reni Benjamin - Citizens JMP Securities, LLC, Research Division Yue-Wen Zhu - LifeSci Capital, LLC, Research Division Erik Lavington - Mizuho Securities USA LLC, Research Division Jiale Song - Jefferies LLC, Research Division Bradley Canino - Guggenheim Securities, LLC, Research Division Philip Nadeau - TD Cowen, Research Division Jason Zemansky - BofA Securities, Research Division Etzer Darout - Barclays Bank PLC, Research Division Xiaochuan Dai - UBS Investment Bank, Research Division Presentation Operator At this time, I would like to welcome you to the Kura Oncology FDA approval conference call. [Operator Instructions] At this time, I would like to turn the call over to Greg Mann from Kura Oncology.

– NPM1 mutations, one of the most common genetic drivers of AML, are now actionable for patients – – Acute unmet need in R/R NPM1-mutated AML defined by historically poor outcomes and low survival rates at relapse – – FDA grants full approval of KOMZIFTI ahead of PDUFA target action date – – Approval is based on the KOMET-001 trial, in which KOMZIFTI demonstrated deep responses, a potentially best-in-class safety profile, once-daily administration, and ease of co-administration with common supportive medications in adult patients with R/R NPM1-mutated AML – – KOMZIFTI approval granted with no Boxed Warning related to QTc prolongation or Torsades de Pointes – – Kura Oncology will host a conference call on November 13, 2025, at 12:30 pm ET / 9:30 am PT – SAN DIEGO and TOYKO, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151) today announced the U.S. Food and Drug Administration (FDA) has granted full approval of KOMZIFTI™ (ziftomenib) for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options.

The U.S. Food and Drug Administration has approved Kura Oncology's drug to treat a rare form of blood cancer that has returned or resisted initial therapy, the regulator said on Thursday.

SAN DIEGO, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced its participation in the following investor conference:

SAN DIEGO, Nov. 07, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (the “Company”) (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that on November 3, 2025, the Compensation Committee of the Company's Board of Directors (the “Compensation Committee”) granted inducement awards consisting of nonstatutory stock options to purchase 21,750 shares of common stock to a new non-executive employee under the Company's 2023 Inducement Option Plan, as amended. The Compensation Committee approved the stock options as an inducement material to such employee's employment in accordance with Nasdaq Listing Rule 5635(c)(4).

Kura Oncology, Inc. ( KURA ) Q3 2025 Earnings Call November 4, 2025 8:00 AM EST Company Participants Greg Mann Thomas Doyle - Senior Vice President of Finance & Accounting Troy Wilson - Chairman, CEO & President Mollie Leoni - Chief Medical Officer Brian Powl - Chief Commercial Officer Conference Call Participants Li Wang Watsek - Cantor Fitzgerald & Co., Research Division Jason Zemansky - BofA Securities, Research Division Yue-Wen Zhu - LifeSci Capital, LLC, Research Division Salim Syed - Mizuho Securities USA LLC, Research Division Philip Nadeau - TD Cowen, Research Division Reni Benjamin - Citizens JMP Securities, LLC, Research Division Alexandre Bouilloux - Barclays Bank PLC, Research Division David Ruch Presentation Operator " Greg Mann " Thomas Doyle Senior Vice President of Finance & Accounting " Troy Wilson Chairman, CEO & President " Mollie Leoni Chief Medical Officer " Brian Powl Chief Commercial Officer " Unknown Analyst " Li Wang Watsek Cantor Fitzgerald & Co., Research Division " Cantor Fitzgerald & Co., Research Division Jason Zemansky BofA Securities, Research Division " BofA Securities, Research Division Yue-Wen Zhu LifeSci Capital, LLC, Research Division " LifeSci Capital, LLC, Research Division Operator Good day, everybody. My name is Danny, and I will be your conference operator today.

Kura Oncology (KURA) came out with a quarterly loss of $0.85 per share versus the Zacks Consensus Estimate of a loss of $0.57. This compares to a loss of $0.63 per share a year ago.