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Kura Oncology Announces First Patients Dosed in Phase 1 Combination Trial of Ziftomenib for the Treatment of Advanced GIST
Globenewswire· 2025-04-28 11:30
Core Insights - Kura Oncology has initiated the KOMET-015 Phase 1 clinical trial to evaluate ziftomenib in combination with imatinib for patients with advanced gastrointestinal stromal tumors (GIST) after imatinib failure [1][3] - The combination of ziftomenib and imatinib has shown robust and durable antitumor activity in both imatinib-sensitive and imatinib-resistant GIST preclinical models [1][2] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with ziftomenib being a key investigational menin inhibitor [8] - The company has received Breakthrough Therapy Designation from the FDA for ziftomenib in treating relapsed/refractory NPM1-mutant acute myeloid leukemia (AML) [7][8] Clinical Trial Details - The KOMET-015 trial is designed to assess the safety, tolerability, and preliminary antitumor activity of ziftomenib combined with imatinib in adults with GIST who have shown disease progression on imatinib [3][4] - The trial will evaluate primary objectives including safety and tolerability, and secondary endpoints such as overall response rate (ORR) and progression-free survival (PFS) [3] Market Context - Approximately 4,000 to 6,000 new cases of GIST are diagnosed annually in the U.S., with limited treatment options available for advanced cases [2][5] - Most patients develop resistance to imatinib within two years, highlighting the need for new therapeutic options [2][6] Preclinical Findings - Preclinical studies indicate that the combination of ziftomenib and imatinib exerts antitumor activity through a synthetic lethal mechanism, targeting vulnerabilities in GIST tumors [2][3] - The combination has the potential to delay or overcome resistance to imatinib in patients [2]
Kura Oncology to Report First Quarter 2025 Financial Results
Globenewswire· 2025-04-24 11:30
SAN DIEGO, April 24, 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 it will report first quarter 2025 financial results after the close of U.S. financial markets on Thursday, May 1, 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 up ...
Kura Oncology and Kyowa Kirin Announce Submission of New Drug Application for Ziftomenib to FDA
Newsfilter· 2025-04-08 11:30
SAN DIEGO and TOKYO, April 08, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (NASDAQ:KURA, "Kura")), and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin"), today announced Kura submitted a New Drug Application (NDA) for ziftomenib, a highly selective, once-daily, oral, investigational menin inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM 1) mutation to the U.S. Food and Drug Administration (FDA) on March 31, 2025. Ziftom ...
Kura Oncology to Participate in Stifel Targeted Oncology Forum
Newsfilter· 2025-04-01 11:30
About Kura Oncology Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company's pipeline consists of small molecule drug candidates that target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the treatment of relapsed/refractory ("R/R") NPM1-mutan ...
Kura Oncology Announces Preclinical Data for KO-2806 Selected for Oral Presentation at the 2025 AACR Annual Meeting
Newsfilter· 2025-03-26 11:30
– Oral presentation to highlight preclinical data further supporting combination of KO-2806 with TKIs in ccRCC – – Company expects to present data from the Phase 1 FIT-001 trial evaluating KO-2806 and cabozantinib in patients with RCC in 2H 2025 – SAN DIEGO, March 26, 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 that an abstract containing preclinic ...
Kura Oncology: The Market Sees A Tough Road Ahead, And I Think There's An Opportunity
Seeking Alpha· 2025-03-04 15:12
Kura Oncology (NASDAQ: KURA ) is a pharmaceutical company best known for being one of the pioneers in a novel form of targeted therapy that is currently causing a major stir among researchers inI have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you do your due diligence and not get burned by the pitfalls of investing in this s ...
Kura Oncology(KURA) - 2024 Q4 - Annual Report
2025-02-28 21:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 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 12(g) of the Act: None Indicate by check mark if the registrant is a well ...
Kura Oncology(KURA) - 2024 Q4 - Earnings Call Transcript
2025-02-27 09:46
Kura Oncology, Inc. (NASDAQ:KURA) Q4 2024 Earnings Conference Call February 26, 2025 4:30 PM ET Company Participants Patti Bank - IR Troy Wilson - President and CEO Mollie Leoni - CMO Tom Doyle - SVP of Finance and Accounting Brian Powl - CCO Conference Call Participants Li Watsek - Cantor Fitzgerald Yen-Der Li - Leerink Partners Jason Zemansky - Bank of America Peter Lawson - Barclays Dara Azar - Stifel Charles Zhu - LifeSci Capital David Dai - UBS Justin Zelin - BTIG George Farmer - Scotiabank Operator Go ...
Kura Oncology(KURA) - 2024 Q4 - Earnings Call Presentation
2025-02-27 07:18
CORPORATE PRESENTATION Our goal is to develop transformative therapies to extend and improve the lives of patients with cancer February 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, plans regarding regulatory filings, our expectations regarding the relative benefits o ...
Kura Oncology (KURA) Reports Q4 Loss, Lags Revenue Estimates
ZACKS· 2025-02-26 23:35
Kura Oncology (KURA) came out with a quarterly loss of $0.22 per share versus the Zacks Consensus Estimate of a loss of $0.63. This compares to loss of $0.55 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 65.08%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.64 per share when it actually produced a loss of $0.63, delivering a surprise of 1.56%.Over the last four quarters, the compa ...