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, Inc. (Nasdaq: KURA) will release its fourth quarter and full year 2022 financial results on February 23, 2023, after U.S. market close. A conference call and webcast will follow at 4:30 p.m. ET to discuss the results and provide corporate updates. Kura is focused on precision medicine for cancer, with ongoing trials for its drug candidates. Ziftomenib is in a registration-directed trial for NPM1-mutant acute myeloid leukemia, while Tipifarnib has received Breakthrough Therapy Designation in treating HRAS-mutant head and neck squamous cell carcinoma. To join the call, U.S. callers can dial 1-877-407-4018.
Kura Oncology (Nasdaq: KURA) announced the initiation of its KOMET-001 Phase 2 trial for ziftomenib, a novel menin inhibitor targeting NPM1-mutant relapsed or refractory acute myeloid leukemia (AML). This follows promising Phase 1 results, which showed a 30% complete response rate among 20 patients at the recommended dosage of 600 mg. The Phase 2 trial aims to enroll 85 patients across the U.S. and Europe, focusing on complete response and safety as primary endpoints. Ziftomenib has received Orphan Drug Designation from the FDA, underscoring its potential in addressing the high unmet needs of AML patients with NPM1 mutations.
Kura Oncology, a clinical-stage biopharmaceutical company focused on precision cancer therapies, announced its participation in the virtual SVB Securities Global Biopharma Conference. CEO Troy Wilson will engage in a fireside chat at 5:00 p.m. ET on February 14, 2023. A live audio webcast will be accessible on Kura's website, with an archived replay available thereafter. Kura's pipeline includes Ziftomenib for acute myeloid leukemia and Tipifarnib, which has received Breakthrough Therapy Designation for HRAS-mutant head and neck squamous cell carcinoma. Kura is also advancing KO-2806 through early clinical studies.
Kura Oncology (Nasdaq: KURA) announced that the FDA has cleared its Investigational New Drug (IND) application for KO-2806, a next-generation farnesyl transferase inhibitor (FTI) aimed at treating advanced solid tumors. The company plans to conduct a Phase 1 first-in-human study to assess the safety, tolerability, and preliminary antitumor activity of KO-2806, both as a monotherapy and in combination with other therapies. Kura aims to start this trial in Q3 2023, with KO-2806 designed to enhance the efficacy of earlier FTI candidates and address drug resistance in cancer treatments. The IND clearance is a pivotal step in expanding Kura's clinical pipeline.
Kura Oncology announced promising results from its KOMET-001 Phase 1/2 trial of ziftomenib for NPM1-mutant and KMT2A-rearranged acute myeloid leukemia (AML). The trial showed a 30% complete remission (CR) rate at a 600 mg dose among 20 NPM1-mutant patients, with a low 5% rate of Grade 3 differentiation syndrome. The FDA has recommended 600 mg as the Phase 2 dose. Kura plans to initiate a registration-directed trial in Q1 2023 and explore combination therapies. These results highlight ziftomenib's potential as a promising treatment in a patient population with significant unmet needs.
Kura Oncology has announced an investor event on December 10, 2022, at 11:15 a.m. CT, following an oral presentation of data from the KOMET-001 trial at the ASH Annual Meeting in New Orleans. This event will feature insights from Kura's management and investigators on ziftomenib, a selective menin inhibitor, currently in Phase 1/2 trials targeting acute myeloid leukemia. Attendees can register for the live webcast on Kura's website, with an archived replay available afterwards.
Kura Oncology, a clinical-stage biopharmaceutical company, announced that its CEO, Troy Wilson, will participate in two investor conferences. The first is a fireside chat at the Evercore ISI HealthCONx Conference on November 29, 2022, at 12:35 p.m. ET. The second is at the JMP Securities Hematology and Oncology Summit on December 7, 2022, at 12:20 p.m. ET. Audio webcasts will be available on Kura's website with archived replays after each event. Kura focuses on precision cancer medicines, with candidates like Ziftomenib in clinical trials.
Kura Oncology (Nasdaq: KURA) has announced that four abstracts concerning ziftomenib, a selective menin inhibitor, have been accepted for presentation at the ASH Annual Meeting on December 10-13, 2022, in New Orleans. Notable is the oral presentation of updated data from the KOMET-001 trial on ziftomenib for treating relapsed/refractory acute myeloid leukemia (AML). These presentations aim to showcase ziftomenib's potential impact on patient outcomes within this critical unmet need.
Kura Oncology reported third quarter 2022 results, highlighting the acceptance of updated KOMET-001 trial data for oral presentation at ASH. The company secured a $25 million equity investment from Bristol Myers Squibb and a $125 million term loan from Hercules Capital, extending financial runway into 2026. Key developments include positive preliminary results for tipifarnib plus alpelisib in HNSCC and the closure of AIM-HN trial to further enrollment. The net loss for Q3 2022 was $35.5 million, with R&D expenses rising to $25 million.
Kura Oncology (Nasdaq: KURA) announced a $25 million equity investment from Bristol Myers Squibb at $18.25 per share and a term loan facility of up to $125 million from Hercules Capital. The funds will support Kura's operations into 2026 if fully drawn. The loan includes an immediate draw of $10 million and potential additional tranches tied to clinical milestones. This collaboration aims to advance Kura's cancer treatments, enhancing their financial strength and strategic development capabilities.