This section highlights FDA-related milestones and regulatory updates for drugs developed by Kura Oncology (KURA).
Over the past two years, Kura Oncology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
KO-2806 and Ziftomenib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
KO-2806 - FDA Regulatory Timeline and Events
KO-2806 is a drug developed by Kura Oncology for the following indication: Inhibitor of farnesyl transferase.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KO-2806
- Announced Date:
- March 26, 2025
- Estimated Event Date Range:
- July 1, 2025 - December 31, 2025
- Target Action Date:
- H2 2025
- Indication:
- Inhibitor of farnesyl transferase
Announcement
Kura Oncology, Inc. expects to present data from the Phase 1 FIT-001 trial evaluating KO-2806 and cabozantinib in patients with RCC in 2H 2025 –
AI Summary
Kura Oncology, Inc. announced that it will present new data at the AACR Annual Meeting that supports the use of its next-generation farnesyl transferase inhibitor, KO-2806. The company is focusing on the potential benefits of combining KO-2806 with cabozantinib, a tyrosine kinase inhibitor, to enhance antitumor activity in clear cell renal cell carcinoma (ccRCC).
Additionally, Kura Oncology expects to share results from its Phase 1 FIT-001 trial, which is evaluating the combination of KO-2806 and cabozantinib in patients with renal cell carcinoma. This data is expected to be presented in the second half of 2025, marking an important step in the company’s efforts to develop new treatment strategies for patients with ccRCC, particularly those who have shown resistance to other therapies.
Read Announcement- Drug:
- KO-2806
- Announced Date:
- March 26, 2025
- Indication:
- Inhibitor of farnesyl transferase
Announcement
Kura Oncology, Inc announced that an abstract containing preclinical data for KO-2806, the Company's next-generation farnesyl transferase inhibitor (FTI), in combination with cabozantinib, a tyrosine kinase inhibitor (TKI), in clear cell renal cell carcinoma (ccRCC), has been accepted for an oral presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting in Chicago, IL on April 29, 2025.
AI Summary
Kura Oncology, Inc. announced that an abstract featuring preclinical data for its next-generation farnesyl transferase inhibitor, KO-2806, in combination with cabozantinib, has been accepted for an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, IL. This presentation, scheduled for April 29, 2025, will showcase data supporting the use of this drug combination in clear cell renal cell carcinoma (ccRCC).
The findings are expected to strengthen the evidence that KO-2806 can boost the antitumor effects of tyrosine kinase inhibitors like cabozantinib. In addition to the preclinical data, the company plans to reveal clinical results from the Phase 1 FIT-001 trial later in 2025, which is testing KO-2806 both as a monotherapy and in combination with cabozantinib for the treatment of ccRCC.
Read Announcement
Ziftomenib - FDA Regulatory Timeline and Events
Ziftomenib is a drug developed by Kura Oncology for the following indication: Treatment of genetically defined AML patients with high unmet need.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Ziftomenib
- Announced Date:
- June 12, 2025
- Indication:
- Treatment of genetically defined AML patients with high unmet need
Announcement
Kura Oncology, Inc. today provided positive updated clinical data from KOMET-007, a Phase 1a/1b trial of ziftomenib, a highly selective oral investigational menin inhibitor, in combination with standards of care in patients with newly diagnosed NPM1-mutant (NPM1-m) and KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML).
AI Summary
Kura Oncology, Inc. announced encouraging updated clinical data from its Phase 1a/1b KOMET-007 trial evaluating ziftomenib, a highly selective oral menin inhibitor, in combination with the standard 7+3 chemotherapy in newly diagnosed acute myeloid leukemia (AML) patients with NPM1-mutant (NPM1-m) or KMT2A-rearranged (KMT2A-r) disease. Results showed composite complete remission rates of 93% in NPM1-m patients and 89% in KMT2A-r patients. Additionally, measurable residual disease negativity was achieved in 71% of NPM1-m and 88% of KMT2A-r patients who responded, while 96% of NPM1-m and 88% of KMT2A-r patients remain alive and on study. The combination treatment was well tolerated, demonstrating no additive myelosuppression or delays in blood recovery. These promising findings support ziftomenib’s potential as a frontline treatment option, with Phase 3 studies expected to begin in the second half of 2025.
Read Announcement- Drug:
- Ziftomenib
- Announced Date:
- June 1, 2025
- Estimated Event Date Range:
- November 30, 2025 - November 30, 2025
- Target Action Date:
- November 30, 2025
- Indication:
- Treatment of genetically defined AML patients with high unmet need
Announcement
Kura Oncology, Inc. announced that The application has been granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2025.
AI Summary
Kura Oncology, Inc. announced that the FDA has accepted its New Drug Application for ziftomenib, a new treatment for adult patients with relapsed or refractory acute myeloid leukemia (AML) carrying an NPM1 mutation. This decision comes after positive results from the Phase 2 KOMET-001 trial, which showed promising effectiveness and a manageable safety profile.
The application has been granted Priority Review, and the FDA has assigned it a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2025. This designation speeds up the review process, highlighting the potential of ziftomenib to become a first-of-its-kind menin inhibitor for a difficult-to-treat form of AML.
Read Announcement- Drug:
- Ziftomenib
- Announced Date:
- June 1, 2025
- Indication:
- Treatment of genetically defined AML patients with high unmet need
Announcement
Kura Oncology, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted Kura's New Drug Application (NDA) seeking full approval for ziftomenib as a treatment for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) mutation.
AI Summary
Kura Oncology, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for ziftomenib. This NDA, aimed at treating adult patients with relapsed or refractory acute myeloid leukemia (AML) carrying a nucleophosmin 1 (NPM1) mutation, marks a significant step for both Kura Oncology and its partner Kyowa Kirin. The application is based on positive results from the Phase 2 KOMET-001 trial, where ziftomenib met its primary endpoints with manageable safety and tolerability.
The FDA has granted Priority Review to the application and set a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2025. Ziftomenib could become the first approved menin inhibitor for this aggressive subtype of AML, offering a promising treatment opportunity for patients who currently have limited options. The companies look forward to continuing their discussions with the FDA during the review process.
Read Announcement- Drug:
- Ziftomenib
- Announced Date:
- May 22, 2025
- Indication:
- Treatment of genetically defined AML patients with high unmet need
Announcement
Kura Oncology, Inc. announced that an abstract highlighting the full data analyses from the KOMET-001 registration-directed trial of ziftomenib, a once-daily, oral investigational menin inhibitor, has been accepted for oral presentation at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held in Chicago, IL from May 30 - June 3, 2025.
AI Summary
Kura Oncology, Inc. announced that full data analyses from its KOMET-001 registration-directed trial of ziftomenib—a once-daily, oral investigational menin inhibitor—will be featured in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The meeting is scheduled to take place in Chicago, IL from May 30 to June 3, 2025.
This presentation will share key findings on the clinical activity and safety of ziftomenib in patients with relapsed/refractory NPM1-mutant acute myeloid leukemia (AML). The trial, designed to evaluate the benefit-risk profile of the drug, has shown encouraging signs of efficacy and safety, highlighting ziftomenib as a promising treatment option for patients with a significant unmet medical need in AML. Kura Oncology is eager to provide more comprehensive insights during their upcoming presentation at ASCO 2025.
Read Announcement- Drug:
- Ziftomenib
- Announced Date:
- May 14, 2025
- Indication:
- Treatment of genetically defined AML patients with high unmet need
Announcement
Kura Oncology, Inc. announced that an abstract highlighting clinical data from the KOMET-007 combination trial of ziftomenib, a once-daily, oral investigational menin inhibitor, has been accepted for presentation at the upcoming 2025 European Hematology Association (EHA) Congress, to be held in Milan, Italy, from June 12-15, 2025.
AI Summary
Kura Oncology, Inc. announced that an abstract featuring clinical data from the KOMET-007 combination trial has been accepted for an oral presentation at the 2025 European Hematology Association (EHA) Congress. The abstract will highlight updated results from the study of ziftomenib, a once-daily, oral investigational menin inhibitor, used in combination with intensive chemotherapy (7+3) in newly diagnosed acute myeloid leukemia (AML) patients with NPM1 mutations or KMT2A rearrangements.
The presentation is scheduled for June 12, 2025, at the Milan Congress in Italy. It will cover data from the initial Phase 1a dose-escalation and Phase 1b dose-expansion parts of the trial. These findings emphasize the potential of combining ziftomenib with standard treatment regimens to possibly improve outcomes in AML patients, setting the stage for more advanced trials in the future.
Read Announcement- Drug:
- Ziftomenib
- Announced Date:
- April 28, 2025
- Indication:
- Treatment of genetically defined AML patients with high unmet need
Announcement
Kura Oncology, Inc. announced that the first patients have been dosed in KOMET-015, a Phase 1 clinical trial of ziftomenib, the Company's potent and selective, oral investigational menin inhibitor, in patients with advanced gastrointestinal stromal tumors (GIST) after imatinib failure.
AI Summary
Kura Oncology, Inc. announced that the first patients have been dosed in KOMET-015, a Phase 1 dose-escalation trial evaluating ziftomenib, a potent and selective oral menin inhibitor. This study targets patients with advanced gastrointestinal stromal tumors (GIST) who have experienced imatinib failure, an area where treatment options remain limited. The trial aims to assess the safety, tolerability, and preliminary antitumor activity of combining ziftomenib with imatinib.
Preclinical studies have indicated that the combination of ziftomenib and imatinib produces robust and durable responses in both imatinib-sensitive and imatinib-resistant GIST models. With approximately 4,000 to 6,000 new GIST cases diagnosed annually in the U.S., this study represents a promising step toward potentially transforming the treatment paradigm for patients facing resistance to current standard therapies.
Read Announcement- Drug:
- Ziftomenib
- Announced Date:
- April 8, 2025
- Indication:
- Treatment of genetically defined AML patients with high unmet need
Announcement
Kura Oncology, Inc 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.
AI Summary
Kura Oncology announced on March 31, 2025 that it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for its investigational drug ziftomenib. This once-daily, oral, highly selective menin inhibitor is being developed for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) mutation—a group in urgent need of new treatment options.
The NDA submission marks an important milestone for Kura Oncology as it aims to advance ziftomenib toward potential approval. The FDA has a 60-day period to review the completeness of the application, with an initial notification expected in the second quarter of 2025. This progress demonstrates the company's commitment to introducing targeted therapies for challenging forms of AML, and it highlights the potential of ziftomenib to address significant unmet medical needs for this patient population.
Read Announcement- Drug:
- Ziftomenib
- Announced Date:
- February 5, 2025
- Indication:
- Treatment of genetically defined AML patients with high unmet need
Announcement
Kura Oncology, Inc. announced positive topline results from KOMET-001, the Phase 2 registration-directed trial of ziftomenib, a highly selective, once-daily, oral investigational menin inhibitor, in patients with relapsed/refractory (R/R) NPM1-mutant (NPM1-m) acute myeloid leukemia (AML).
AI Summary
Kura Oncology, Inc. announced positive topline results from its Phase 2 KOMET-001 trial for ziftomenib, an investigational oral menin inhibitor. The trial focused on patients with relapsed/refractory NPM1-mutant acute myeloid leukemia. The study met its primary endpoint by achieving complete response (CR) and CR with partial hematological recovery (CRh), showing promising benefit-risk results. These positive outcomes suggest that ziftomenib could become a valuable treatment option for these patients.
The topline data have been submitted for presentation at an upcoming medical meeting in the second quarter of 2025. In addition, the company is on track to submit a New Drug Application to the FDA for ziftomenib by that time. This progress supports the potential of ziftomenib to transform treatment approaches in acute myeloid leukemia.
Read Announcement- Drug:
- Ziftomenib
- Announced Date:
- February 5, 2025
- Estimated Event Date Range:
- April 1, 2025 - June 30, 2025
- Target Action Date:
- Q2 2025
- Indication:
- Treatment of genetically defined AML patients with high unmet need
Announcement
Kura is on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ziftomenib in the second quarter of 2025.
AI Summary
Kura Oncology announced positive topline results from its KOMET-001 trial of ziftomenib, a once-daily oral menin inhibitor, in patients with relapsed/refractory NPM1-mutant acute myeloid leukemia (AML). The trial successfully met its primary endpoint, highlighting the potential of ziftomenib as a treatment option for these patients.
Importantly, Kura is on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ziftomenib in the second quarter of 2025. This submission is a key step forward in the development of the drug. In addition, the company plans to start two Phase 3 trials later in 2025, evaluating ziftomenib in combination with both intensive and non-intensive treatment regimens for newly diagnosed AML patients, aiming to broaden therapeutic options and address unmet needs.
Read Announcement- Drug:
- Ziftomenib
- Announced Date:
- December 9, 2024
- Indication:
- Treatment of genetically defined AML patients with high unmet need
Announcement
Kura Oncology, Inc. provided encouraging clinical data from KOMET-007, a Phase 1 dose-escalation trial of ziftomenib, a highly selective oral investigational menin inhibitor, in combination with standards of care, including cytarabine/daunorubicin (7+3) and venetoclax/azacitidine (ven/aza), in patients with NPM1-mutant (NPM1-m) and KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML).
AI Summary
Kura Oncology, Inc. recently shared encouraging results from the Phase 1 dose-escalation portion of the KOMET-007 trial. The trial studied ziftomenib—a selective oral investigational menin inhibitor—in combination with standard treatments, including the 7+3 chemotherapy regimen (cytarabine/daunorubicin) and venetoclax/azacitidine (ven/aza), for patients with NPM1-mutant (NPM1-m) and KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML). In the frontline setting using 7+3, 100% of patients with NPM1 mutations and 83% with KMT2A rearrangements achieved complete remission, and nearly all patients were alive at the data cutoff.
Additionally, promising activity was seen with the ven/aza combination in relapsed/refractory AML patients, even among those with previous venetoclax exposure. Ziftomenib was generally well tolerated, with manageable side effects and no major toxicities, supporting further investigation of this combination approach to improve treatment outcomes for patients with high-risk AML.
Read Announcement- Drug:
- Ziftomenib
- Announced Date:
- September 30, 2024
- Indication:
- Treatment of genetically defined AML patients with high unmet need
Announcement
Kura Oncology, Inc. announced the publication of its KOMET-001 Phase 1 study manuscript in The Lancet Oncology journal.
AI Summary
Kura Oncology, Inc. has recently published its KOMET-001 Phase 1 study in The Lancet Oncology. The study, titled "Ziftomenib in relapsed/refractory acute myeloid leukaemia (KOMET-001): results from an open-label, multi-cohort, phase 1a/1b trial," presents promising findings for the investigational drug ziftomenib. The trial evaluated the safety, tolerability, and initial clinical activity of ziftomenib in 83 patients with NPM1-mutant acute myeloid leukemia. Results from the study showed encouraging benefits such as reduced marrow blasts and improvements in blood cell counts, which support further research and development of the drug.
The publication marks an important step in confirming ziftomenib’s potential as a treatment option for AML patients with significant unmet needs. By providing essential safety and efficacy data, the study lays the groundwork for subsequent trials and could lead to more effective therapies for this aggressive form of cancer. The manuscript is now available on The Lancet Oncology website and on Kura Oncology’s website.
Read Announcement- Drug:
- Ziftomenib
- Announced Date:
- August 8, 2024
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- H1 2025
- Indication:
- Treatment of genetically defined AML patients with high unmet need
Announcement
Kura Oncology, Inc. announced that Proof-of-concept study evaluating ziftomenib and imatinib in patients with advanced GIST to begin in 1H 2025 –
AI Summary
Kura Oncology, Inc. announced that it plans to begin a proof‐of-concept Phase 1 study in early 2025. This trial will evaluate the combination of ziftomenib, a potent menin inhibitor, with imatinib in patients with advanced gastrointestinal stromal tumors (GIST) who have developed resistance to imatinib. Preclinical findings suggest that adding ziftomenib may resensitize patients to imatinib and lead to deeper, long-lasting responses. This study is significant because GIST patients who become resistant to imatinib have few treatment options, and the combination could offer a new approach to overcome resistance. Kura Oncology is optimistic about these early results and plans to share more preclinical data at an upcoming scientific meeting, marking an important step forward in the quest for improved therapies for advanced GIST patients.
Read Announcement- Drug:
- Ziftomenib
- Announced Date:
- August 8, 2024
- Indication:
- Treatment of genetically defined AML patients with high unmet need
Announcement
Kura Oncology, Inc. announced clearance by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for ziftomenib, the Company's potent and selective menin inhibitor, for the treatment of advanced gastrointestinal stromal tumors (GIST).
AI Summary
Kura Oncology, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ziftomenib, a potent and selective menin inhibitor, for advanced gastrointestinal stromal tumors (GIST). This clearance marks the first time an IND for a menin inhibitor has been granted for treating GIST, a solid tumor with limited treatment options for patients with advanced disease.
Preclinical studies indicate that combining ziftomenib with imatinib may help resensitize patients to imatinib, potentially leading to deep and durable responses even after imatinib resistance has developed. Kura Oncology plans to begin a Phase 1 first-in-human proof-of-concept study during the first half of 2025 to further evaluate the combination treatment's safety and effectiveness.
Read Announcement- Drug:
- Ziftomenib
- Announced Date:
- May 14, 2024
- Indication:
- Treatment of genetically defined AML patients with high unmet need
Announcement
Kura Oncology, Inc. announced that it has completed enrollment of 85 patients in the Phase 2 portion of KOMET-001, a registration-directed clinical trial of the Company's menin inhibitor, ziftomenib (KO-539), in patients with relapsed or refractory (R/R) NPM1-mutant acute myeloid leukemia (AML). The Company expects to report topline data from the trial in early 2025.
Read Announcement- Drug:
- Ziftomenib
- Announced Date:
- April 22, 2024
- Estimated Event Date Range:
- January 1, 2024 - June 30, 2024
- Target Action Date:
- H1 2024
- Indication:
- Treatment of genetically defined AML patients with high unmet need
Announcement
Kura Oncology, Inc. announced that Registration-directed trial of ziftomenib in NPM1-mutant AML on track to complete enrollment by mid-2024 –
AI Summary
Kura Oncology has announced that its registration-directed trial of ziftomenib for patients with relapsed/refractory NPM1-mutant acute myeloid leukemia (AML) is on track to complete enrollment by mid-2024. This trial is aimed at assessing both the safety and effectiveness of ziftomenib, a once-daily oral drug designed to offer a targeted treatment option for a form of AML that represents about 30% of new cases. By focusing on NPM1-mutant AML, the study seeks to address a serious unmet need in the field, as patients with this mutation often face poor survival outcomes with current therapies.
The trial’s progress underlines Kura Oncology’s commitment to advancing precision cancer medicine. Alongside efforts to evaluate ziftomenib as a single agent, the company is also exploring its use in combination with other standard treatments, which could lead to improved outcomes for patients in urgent need of better therapeutic options.
Read Announcement- Drug:
- Ziftomenib
- Announced Date:
- April 22, 2024
- Indication:
- Treatment of genetically defined AML patients with high unmet need
Announcement
Kura Oncology, Inc. announced that its investigational drug, ziftomenib, has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed/refractory (R/R) NPM1-mutant acute myeloid leukemia (AML).
AI Summary
Kura Oncology, Inc. has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for its investigational drug ziftomenib. This designation is aimed at expediting the development and review process since early clinical data from the ongoing KOMET-001 trial shows considerable promise for patients with relapsed/refractory NPM1-mutant acute myeloid leukemia (AML). The FDA granted BTD because the preliminary evidence suggests that ziftomenib may provide a substantial improvement over current treatment options. NPM1-mutant AML is an area with significant unmet needs, as it accounts for roughly 30% of new AML cases and has no approved targeted therapy. Kura Oncology is committed to advancing ziftomenib swiftly, and they expect to complete patient enrollment in the registration-directed trial by mid-2024, bringing hope to patients in urgent need of effective treatments.
Read Announcement
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