Welcome to our dedicated page for Kura Oncology news (Ticker: KURA), a resource for investors and traders seeking the latest updates and insights on Kura Oncology stock.
Kura Oncology, Inc. (Nasdaq: KURA) is a biopharmaceutical company focused on precision medicines for cancer, and its news flow reflects the evolution of this strategy. Company announcements highlight progress with KOMZIFTI (ziftomenib), an oral menin inhibitor approved in the United States for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options.
News items for KURA commonly cover regulatory milestones, clinical data and commercial updates. Recent releases describe full FDA approval of KOMZIFTI, its addition to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology as a Category 2A recommended option for relapsed or refractory NPM1-mutated AML, and the start of U.S. commercial sales. Kura also reports on its collaboration with Kyowa Kirin, including milestone payments tied to clinical and commercial events.
Investors following KURA news can expect detailed coverage of clinical trial readouts from programs such as KOMET-001, KOMET-007 and KOMET-017, which evaluate ziftomenib across newly diagnosed and relapsed or refractory AML, often in combination with regimens like cytarabine/daunorubicin and venetoclax/azacitidine. Additional news addresses the company’s farnesyl transferase inhibitor programs, darlifarnib and tipifarnib, and their activity in solid tumors.
Kura’s press releases also include corporate updates such as financial results, inducement equity grants under Nasdaq Listing Rule 5635(c)(4), and participation in scientific and investor conferences. For readers tracking KURA, this news page offers a centralized view of key developments in its precision oncology pipeline, regulatory interactions, collaborations and commercialization activities.
Kura Oncology (KURA) reported positive Q4 and full year 2024 results, highlighting the success of its KOMET-001 registrational trial in R/R NPM1-mutant AML, which achieved its primary endpoint. The company plans to submit a New Drug Application in Q2 2025.
Key financial highlights include collaboration revenue of $53.9M, R&D expenses of $170.0M for 2024 (up from $115.2M in 2023), and G&A expenses of $77.1M (up from $50.6M). The company reported a net loss of $174.0M for 2024. Cash position stands at $727.4M, including a $330.0M upfront payment from Kyowa Kirin partnership.
Strategic developments include alignment with FDA and EMA on KOMET-017 protocol, with anticipated topline MRD-negative CR results in 2028. The company's partnership with Kyowa Kirin supports ziftomenib commercialization through frontline AML combination setting.
Kura Oncology (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, announced that its President and CEO Troy Wilson will participate in three upcoming investor conferences in March 2025:
- TD Cowen Health Care Conference in Boston (March 4, 2025, 2:30 p.m. ET)
- Barclays Global Healthcare Conference in Miami (March 11, 2025, 9:30 a.m. ET)
- Leerink Partners Global Biopharma Conference in Miami (March 12, 2025, 8:00 a.m. ET)
Live audio webcasts will be available on Kura's website investor section at kuraoncology.com, with archived replays available after the events.
Kura Oncology (KURA), a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, has announced it will release its Q4 and full year 2024 financial results after U.S. market close on Wednesday, February 26, 2025.
The company will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT on the same day to discuss financial results and provide a corporate update. Investors can access the live call via phone using the numbers (800) 579-2543 (domestic) or (785) 424-1789 (international) with conference ID: KURAQ4. A live webcast and replay will be available on the company's investor relations website.
Kura Oncology (Nasdaq: KURA) has announced that its Compensation Committee granted inducement awards to nine new employees on February 3, 2025. The awards consist of nonstatutory stock options to purchase 164,000 shares of common stock under the Company's 2023 Inducement Option Plan.
The stock options have an exercise price of $8.25 per share, matching the Company's closing sales price on February 3, 2025. The options will vest over four years, with 25% vesting after one year and the remaining balance vesting monthly over the subsequent 36 months, contingent on continued employment.
Kura Oncology and Kyowa Kirin announced positive results from their KOMET-001 Phase 2 trial of ziftomenib, an oral menin inhibitor for relapsed/refractory NPM1-mutant acute myeloid leukemia (AML). The trial achieved its primary endpoint with statistical significance, showing promising benefit-risk profile.
The companies plan to submit a New Drug Application (NDA) to the FDA in Q2 2025. Additionally, they received positive FDA feedback for two Phase 3 trials (KOMET-017) evaluating ziftomenib in combination therapies for newly diagnosed AML patients:
- KOMET-017-IC trial: combining with intensive chemotherapy
- KOMET-017-NIC trial: combining with venetoclax/azacitidine
Both Phase 3 trials are expected to begin in H2 2025, with dual-primary endpoints supporting potential accelerated and full FDA approval.
Kura Oncology (NASDAQ: KURA) announced key leadership changes with Mollie Leoni, M.D. promoted to Chief Medical Officer and Francis Burrows, Ph.D. elevated to Chief Scientific Officer. Stephen Dale, M.D., stepped down as CMO on January 2, 2025, to address personal health issues.
Dr. Leoni, who joined Kura in 2020, has been instrumental in developing ziftomenib, a potential therapy for acute myeloid leukemia (AML). Dr. Burrows, with the company since 2014, has led pipeline innovation targeting various conditions including gastrointestinal stromal tumors, diabetes, clear cell renal cell carcinoma, and KRAS-mutated non-small cell lung cancer.
Under Dr. Dale's leadership, the company successfully managed Project Optimus, advanced ziftomenib through its first registration-enabling study, and established foundations for KO-2806 as a combination treatment for multiple solid tumor indications.
Kura Oncology and Kyowa Kirin announced positive interim data from the Phase 1a portion of KOMET-007 trial, evaluating ziftomenib in combination with standard treatments for acute myeloid leukemia (AML). The study showed impressive results with a 100% complete remission rate in NPM1-m and 83% in KMT2A-r first-line adverse risk AML patients when combined with 7+3 therapy.
Key highlights include 100% survival rate in first-line NPM1-m and 96% in KMT2A-r AML patients, with median follow-up of 31 and 19 weeks respectively. The drug demonstrated promising activity in relapsed/refractory cases with venetoclax/azacitidine combination. Ziftomenib was well-tolerated across all dose levels, with manageable side effects.
Based on these positive results, the companies plan to initiate KOMET-017, a global Phase 3 study, in mid-2025.
Kura Oncology (NASDAQ: KURA) has announced a virtual investor event scheduled for December 9, 2024, at 8:00 a.m. ET / 5:00 a.m. PT. The event will discuss updated clinical data from the KOMET-007 combination trial of ziftomenib, their oral and selective menin inhibitor, following its presentation at the 66th American Society of Hematology (ASH) Annual Meeting in San Diego.
The event will feature management team members and KOMET-007 trial investigators. Participants can join via phone (domestic: 800-715-9871, international: 646-307-1963, conference ID: 4326549) or through a live webcast available on Kura's website.
Kura Oncology (NASDAQ: KURA) announced its upcoming participation in the JMP Securities Hematology and Oncology Summit. Troy Wilson, President and Chief Executive Officer, will participate in a virtual fireside chat on December 2, 2024, at 2:00 p.m. ET / 11:00 a.m. PT. The event will be accessible via live audio webcast through the Investors section of Kura's website, with a replay available after the event.
Kura Oncology and Kyowa Kirin have announced a global strategic collaboration for developing and commercializing ziftomenib, a selective oral menin inhibitor for acute leukemias. The deal includes a $330 million upfront payment to Kura and potential milestone payments totaling $1.2 billion. The companies will share 50/50 profits in the U.S., with Kura leading U.S. operations and Kyowa Kirin having exclusive rights outside the U.S. The collaboration aims to advance ziftomenib through various development stages, including frontline indications and combinations. Kura expects to submit a New Drug Application in 2025 and initiate Phase 3 frontline studies in AML patients.