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Kura Oncology (KURA) Reports Q2 Loss, Lags Revenue Estimates
ZACKS· 2025-08-07 23:16
Kura Oncology (KURA) came out with a quarterly loss of $0.75 per share versus the Zacks Consensus Estimate of $0.15. This compares to a loss of $0.59 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -600.00%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.51 per share when it actually produced a loss of $0.66, delivering a surprise of -29.41%.Over the last four quarters, the company h ...
Kura Oncology(KURA) - 2025 Q2 - Earnings Call Transcript
2025-08-07 21:30
Kura Oncology (KURA) Q2 2025 Earnings Call August 07, 2025 04:30 PM ET Speaker0Thank you for your continued patience. Your meeting will begin shortly. Thank you for your continued patience. Your meeting will begin shortly. Thank Thank you for your continued patience.Your meeting will begin shortly. If you need assistance at any time, please press 0 and a member of our team will be happy to help you. Hello, and welcome, everyone, joining today's Second Quarter twenty twenty '5 Cura Oncology, Inc. Financial R ...
Kura Oncology(KURA) - 2025 Q2 - Quarterly Report
2025-08-07 20:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-37620 KURA ONCOLOGY, INC. Securities registered pursuant to Section 12(b) of the Act: | Title of each class | ...
Kura Oncology(KURA) - 2025 Q2 - Quarterly Results
2025-08-07 20:10
Exhibit 99.1 Kura Oncology Reports Second Quarter 2025 Financial Results – FDA Priority Review of New Drug Application (NDA) for ziftomenib in adults with R/R NPM1-m AML with Prescription Drug User Fee Act (PDUFA) target action date set for November 30, 2025 – – Fully engaged in commercial readiness activities in alignment with regulatory review timeline – – $630.7 million in pro forma cash, together with anticipated collaboration agreement payments, expected to support ziftomenib commercialization through ...
Kura Oncology to Report Second Quarter 2025 Financial Results
Globenewswire· 2025-07-31 11:30
SAN DIEGO, July 31, 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 it will report second quarter 2025 financial results after the close of U.S. financial markets on Thursday, August 7, 2025. Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT to discuss the financial results and provide a corporate update. The liv ...
Kura Oncology (KURA) Earnings Call Presentation
2025-06-19 11:58
2025 EHA ANALYST AND INVESTOR EVENT Our goal is to develop transformative therapies to extend and improve the lives of patients with cancer June 18, 2025 FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements. Such statements include, but are not limited to, statements regarding our research, preclinical and clinical development activities, plans and projected timelines for ziftomenib, KO-2806 and tipifarnib, expectations regarding the relative benefits of our product candidates ve ...
Kura Oncology (KURA) Update / Briefing Transcript
2025-06-18 21:30
Kura Oncology (KURA) EHA Virtual Investor Event Summary Company Overview - **Company**: Kura Oncology (KURA) - **Event Date**: June 18, 2025 - **Focus**: Update on ZIFTOMENED, an investigational Menin inhibitor for acute myeloid leukemia (AML) Key Points Industry Context - **Acute Myeloid Leukemia (AML)**: - Approximately 22,000 new cases annually in the U.S. - Median age of diagnosis is 69 years, with most patients diagnosed above this age [9][10] - Current therapies have limited long-term success, especially for older patients, with a 5-year survival rate of 60% to 50% for favorable AML [11] ZIFTOMENED Overview - **Investigational Drug**: ZIFTOMENED is under FDA review for relapsed and refractory NPM1 mutant AML, with a PDUFA target action date of November 30, 2025 [5] - **Partnership**: Collaboration with Kewa Kirin to advance the drug's development and commercialization [5] Clinical Data and Trials - **Phase 1 Study**: - Focused on the combination of ZIFTOMENED with intensive chemotherapy (7+3) for newly diagnosed AML patients with specific mutations (NPM1 and KMT2A) [15][16] - 82 patients enrolled, with a median age of 56; 93% remained on study at the data cutoff [22][18] - Safety profile similar to standard chemotherapy, with common adverse events including febrile neutropenia [22][23] - **Efficacy Results**: - Composite complete remission (CR) rates: 93% for NPM1 mutated patients and 89% for KMT2A rearranged patients [24] - Measurable residual disease (MRD) negativity rates: 68% for NPM1 mutated and 83% for KMT2A rearranged patients [25][32] - Median duration of CR not reached for both patient groups, indicating promising long-term outcomes [25][27] Market Opportunity - **Addressable Market**: - Estimated at over $7 billion annually for AML treatment, based on the potential to treat approximately 10,000 patients with Menin inhibitors for 12-24 months [47] - High unmet medical need, with 70% of patients relapsing within three years post-CR [47] Future Directions - **Clinical Trials**: - Plans to initiate two Phase 3 trials (COMMENT 17) to evaluate ZIFTOMENED in combination with high-intensity chemotherapy and in the maintenance setting post-transplant [38][50] - Focus on achieving MRD negativity as a primary endpoint, which is crucial for improving overall survival [40] Additional Insights - **Patient Management**: - Discussion on the potential to reduce the need for stem cell transplants by achieving deeper remissions with Menin inhibitors [61][62] - Importance of MRD negativity in guiding treatment decisions and improving patient outcomes [40][62] Conclusion - Kura Oncology is positioned to make significant advancements in the treatment of AML with ZIFTOMENED, addressing a critical unmet need in the market and aiming for improved patient outcomes through innovative therapies and clinical strategies [49][50]
Is the Options Market Predicting a Spike in Kura Oncology Stock?
ZACKS· 2025-06-12 13:51
Company Overview - Kura Oncology, Inc. (KURA) is currently experiencing significant activity in the options market, particularly with the July 18, 2025 $2.50 Put option showing high implied volatility, indicating potential for a major price movement [1][3] Analyst Sentiment - Kura Oncology holds a Zacks Rank 3 (Hold) within the Medical - Biomedical and Genetics industry, which is in the top 30% of the Zacks Industry Rank [3] - Over the past 60 days, four analysts have raised their earnings estimates for the current quarter, while one has lowered theirs, resulting in a shift in the Zacks Consensus Estimate from a loss of $0.62 per share to a profit of $0.21 per share [3] Options Market Insights - The high implied volatility surrounding Kura Oncology suggests that options traders anticipate a significant price movement, which could be indicative of an upcoming event that may lead to either a rally or a sell-off [2][4] - Seasoned options traders often seek out high implied volatility options to sell premium, aiming to benefit from the decay of the option's value if the underlying stock does not move as much as expected by expiration [4]
Kura Oncology and Kyowa Kirin Report Positive Updated Combination Data for Ziftomenib in Newly Diagnosed AML at 2025 European Hematology Association Congress
GlobeNewswire News Room· 2025-06-12 11:30
Core Insights - The KOMET-007 trial demonstrated encouraging clinical activity for ziftomenib in combination with 7+3 for newly diagnosed NPM1-m and KMT2A-r AML patients, showing high rates of complete remission and minimal residual disease negativity [1][2][4] Group 1: Clinical Data - In the KOMET-007 trial, 93% (41/44) of NPM1-m patients and 89% (24/27) of KMT2A-r patients achieved complete remission composite (CRc) [1] - Among responding patients, 71% (24/34) of NPM1-m and 88% (14/16) of KMT2A-r patients achieved measurable residual disease (MRD) negativity [1] - The median follow-up times were 24.9 weeks for NPM1-m patients and 15.7 weeks for KMT2A-r patients, with 96% (47/49) of NPM1-m and 88% (29/33) of KMT2A-r patients remaining alive [3] Group 2: Safety and Tolerability - The safety profile of ziftomenib was consistent with previous data, with Grade 3 adverse events occurring in over 10% of patients, including febrile neutropenia (15%) and decreased platelet count (15%) [4] - No dose-limiting toxicities or additive myelosuppression were observed, indicating a favorable safety profile for ziftomenib [4] Group 3: Future Developments - Kura Oncology plans to initiate the KOMET-017-IC and NIC Phase 3 studies in the second half of 2025 to further evaluate ziftomenib's efficacy in AML treatment [1][5] - A virtual investor event is scheduled for June 18, 2025, to discuss the results and broader development plans for ziftomenib [6] Group 4: Company Background - Kura Oncology is focused on developing precision medicines for cancer, with ziftomenib being the first investigational therapy to receive Breakthrough Therapy Designation from the FDA for R/R NPM1-m AML [7] - Kyowa Kirin, a partner in the development of ziftomenib, has a long history in drug discovery and biotechnology innovation, aiming to address high unmet medical needs [9]
Kura Oncology (KURA) FY Conference Transcript
2025-06-10 16:22
Kura Oncology (KURA) FY Conference June 10, 2025 11:20 AM ET Speaker0 Thanks Speaker1 everyone for joining us. I'm Andrea Newkirk, one of the biotech analysts here at Goldman Sachs and I'm really pleased to be joined by Troy Wilson, President and CEO of Cura Oncology. Thanks so much Troy for joining us. Speaker0 My pleasure. Thank you for the chance to participate. Speaker1 Yeah, of course. Well maybe I will open it up to you for some high level remarks on the company, the overview of your clinical programs ...