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. reports news on its precision oncology business, including commercialization of KOMZIFTI™ (ziftomenib), an FDA-approved once-daily oral menin inhibitor for adults with relapsed or refractory NPM1-mutated acute myeloid leukemia. Company updates also cover small-molecule drug candidates designed to target cancer signaling pathways across hematologic malignancies and solid tumors.
Recurring KURA developments include financial results, corporate updates, clinical data presentations, collaboration-related milestones, healthcare conference participation and Nasdaq inducement grants. News on darlifarnib (KO-2806) follows the company’s farnesyl transferase inhibitor program, including studies in combination with cabozantinib for clear cell renal cell carcinoma.
Kura Oncology (Nasdaq: KURA) will report third quarter 2025 financial results on Tuesday, November 4, 2025 before U.S. markets open. Management will host a conference call and webcast at 8:00 a.m. ET / 5:00 a.m. PT to discuss results and provide a corporate update.
The live webcast and archived replay will be available on the company’s investor relations website at www.kuraoncology.com.
Kura Oncology (Nasdaq: KURA) received a $30 million development milestone payment on Oct 24, 2025 after dosing the first patient in the frontline acute myeloid leukemia (AML) Phase 3 program for ziftomenib under its collaboration with Kyowa Kirin.
The payment followed the Sept 29, 2025 launch of KOMET-017 (NCT07007312), two global, randomized, double-blind, placebo-controlled Phase 3 trials testing once-daily oral menin inhibitor ziftomenib in newly diagnosed NPM1-mutated or KMT2A-rearranged AML across both intensive and non-intensive chemotherapy regimens.
Kura states KOMET-017 is the only menin inhibitor registrational program pursuing both chemotherapy settings.
Kura Oncology (Nasdaq: KURA) announced preliminary clinical and preclinical results for its farnesyl transferase inhibitor programs presented at ESMO 2025, highlighting darlifarnib (KO-2806) and tipifarnib combinations.
Key highlights: darlifarnib monotherapy showed tolerable dosing from 3–10 mg/day with on‑target activity in HRAS‑mutant tumors; darlifarnib+cabozantinib produced an ORR of 33–50% and DCR of 80–100% in clear cell RCC (50% ORR reported in an RCC cohort); tipifarnib+alpelisib produced an ORR of 47% at tipifarnib 1200 mg + alpelisib 250 mg in PIK3CA‑altered HNSCC. A virtual investor event and webcast were scheduled for October 18, 2025.
Kura Oncology (Nasdaq: KURA) announced that on October 1, 2025 its Compensation Committee granted inducement awards under the 2023 Inducement Option Plan to seven new employees.
The awards consist of 122,250 nonstatutory stock options with an exercise price of $9.20 per share (closing price on October 1, 2025). Options vest over four years: 25% at the one-year anniversary and the remainder monthly over 36 months, subject to continued service, and are governed by the plan and option agreements.
Kura Oncology (NASDAQ:KURA) and Kyowa Kirin (TSE:4151) have initiated patient dosing in a new cohort of the KOMET-007 clinical trial, evaluating the combination of ziftomenib with cytarabine, daunorubicin, and quizartinib in newly diagnosed acute myeloid leukemia (AML) patients.
The trial targets patients with FLT3/NPM1 co-mutations, which affect approximately 30% of newly diagnosed adult AML patients and up to 50% of adult patients with NPM1-mutated AML. Ziftomenib, which has received FDA Breakthrough Therapy Designation for treating adult patients with relapsed/refractory NPM1-mutated AML, will be evaluated for safety, tolerability, and activity in combination with intensive chemotherapy and quizartinib.
Kura Oncology (NASDAQ:KURA) and Kyowa Kirin (TSE:4151) have announced the dosing of the first patient in their pivotal Phase 3 KOMET-017 trial for ziftomenib, an investigational menin inhibitor for frontline Acute Myeloid Leukemia (AML) treatment.
The trial consists of two independent global studies evaluating ziftomenib in combination with both intensive and non-intensive regimens for patients with newly diagnosed NPM1-mutated or KMT2A-rearranged AML. The intensive chemotherapy trial will assess MRD negative CR and EFS as dual-primary endpoints, while the non-intensive trial will evaluate CR and overall survival. The studies are designed to support potential U.S. accelerated and full approval.
The trial will enroll patients across 200 sites worldwide and targets nearly half of newly diagnosed AML patients. This program is notable as the only menin inhibitor actively pursuing registrational trials across both intensive and non-intensive chemotherapy settings.
Kura Oncology (NASDAQ:KURA) and Kyowa Kirin announced the publication of pivotal KOMET-001 trial results for ziftomenib in the Journal of Clinical Oncology. The trial, evaluating this oral menin inhibitor in relapsed/refractory NPM1-mutated AML patients, met its primary endpoint with a CR/CRh rate of 22%, significantly exceeding the 12% historical standard.
Key findings include a 33% overall response rate, median overall survival of 6.6 months, and 61% MRD-negative rate among CR/CRh responders. The drug showed consistent efficacy across subgroups and demonstrated a favorable safety profile. The FDA has set a PDUFA date of November 30, 2025 for priority review.
[ "Met primary endpoint with CR/CRh rate of 22%, significantly higher than 12% historical standard", "61% of CR/CRh responders achieved MRD-negative status", "Favorable safety profile with low discontinuation rate (3%)", "Consistent efficacy across patient subgroups regardless of prior treatments", "FDA granted Priority Review with PDUFA date set for November 30, 2025" ]Kura Oncology (NASDAQ:KURA), a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, has announced its upcoming participation in the UBS Virtual Oncology Day. The management presentation is scheduled for October 1, 2025, at 2:30 p.m. ET.
Investors can access the live audio webcast through the Investors section of Kura's website, with a replay available after the event.
Kura Oncology (NASDAQ:KURA) hosted an analyst/investor event showcasing preclinical data for its farnesyl transferase inhibitor (FTI) program, specifically highlighting KO-2806 (darlifarnib). The data demonstrates the potential of FTIs to overcome drug resistance when combined with PI3Kα inhibitors, KRAS inhibitors, and antiangiogenic tyrosine kinase inhibitors (TKIs) across multiple tumor types.
The company's next-generation FTI, KO-2806, shows superior potency and enhanced properties compared to first-generation candidates. Preclinical studies revealed that FTIs effectively suppress mTOR signaling and demonstrate the potential to impact over 200,000 incident patients annually in the U.S. across various cancers including renal cell carcinoma, neuroendocrine tumors, NSCLC, colorectal cancer, and breast cancer.
Preliminary clinical data for KO-2806 will be presented at the ESMO Congress 2025 in October, with three scheduled presentations.
Kura Oncology (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on precision cancer medicines, has announced inducement grants to seven new employees. The Compensation Committee approved nonstatutory stock options to purchase 82,950 shares of common stock under the company's 2023 Inducement Option Plan.
The stock options have an exercise price of $7.95 per share, matching the closing price on September 2, 2025. The options will vest over four years, with 25% vesting after one year and the remainder vesting monthly over the following 36 months, contingent on continued employment.