Kura Oncology Inc Stock Price, News & Analysis

The FDA has accepted Kura Oncology and Kyowa Kirin's New Drug Application (NDA) for ziftomenib, granting Priority Review for treating adult patients with relapsed or refractory NPM1-mutant acute myeloid leukemia (AML). The PDUFA target action date is set for November 30, 2025. The NDA is supported by positive results from the Phase 2 KOMET-001 trial, which met its primary endpoint of complete remission plus CR with partial hematological recovery. Ziftomenib demonstrated a favorable safety profile with limited myelosuppression and only 3% treatment-related discontinuations. The drug has received multiple FDA designations including Breakthrough Therapy, Fast Track, and Orphan Drug. If approved, ziftomenib would be the first menin inhibitor for treating this aggressive form of AML.

Kura Oncology and Kyowa Kirin announced that data from their KOMET-001 registration-directed trial of ziftomenib will be presented at the 2025 ASCO Annual Meeting. Ziftomenib, a daily oral menin inhibitor, is being evaluated for relapsed/refractory NPM1-mutant acute myeloid leukemia (AML). The drug achieved its primary endpoint of complete remission plus CR with partial hematological recovery, with statistical significance. Notably, ziftomenib is the only investigational therapy to receive Breakthrough Therapy Designation from the FDA for this indication. The treatment showed promising results with limited myelosuppression and only 3% treatment-related discontinuations. NPM1 mutations represent approximately 30% of AML cases, with no FDA-approved therapies currently available. The detailed results will be presented on June 2nd, 2025, followed by a virtual investor event.

Kura Oncology (NASDAQ: KURA), a clinical-stage biopharmaceutical company focused on developing precision medicines for cancer treatment, has announced its participation in three major upcoming investor conferences in May and June 2025:

• TD Cowen 6th Annual Oncology Innovation Summit (Virtual) - May 27, 2025, at 9:00 a.m. ET
• Jefferies Global Healthcare Conference (NYC) - June 4, 2025, at 2:35 p.m. ET
• Goldman Sachs Annual Global Healthcare Conference (Miami) - June 10, 2025, at 11:20 a.m. ET

Live webcasts will be available on Kura's website with archived replays accessible after the events.

Kura Oncology (NASDAQ: KURA) and Kyowa Kirin announced that data from their KOMET-007 trial of ziftomenib will be presented at the 2025 European Hematology Association Congress in Milan. The presentation will focus on clinical data from combining ziftomenib, an oral menin inhibitor, with standard chemotherapy (7+3) in newly diagnosed NPM1-mutant and KMT2A-rearranged acute myeloid leukemia (AML) patients. The data comes from Phase 1a dose-escalation and Phase 1b dose-expansion portions of the trial. Two additional abstracts for the KOMET-001 and KOMET-017 trials will also be presented. Dr. Mollie Leoni, Chief Medical Officer of Kura Oncology, expressed confidence in ziftomenib's potential as a treatment option for AML patients when combined with intensive chemotherapy.

Kura Oncology (NASDAQ: KURA), a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, has announced its upcoming participation in the Bank of America Securities 2025 Healthcare Conference. The company's President and CEO, Troy Wilson, Ph.D., J.D., will engage in a fireside chat on May 13, 2025, at 6:00 p.m. ET / 3:00 p.m. PT. Investors can access a live audio webcast of the presentation through Kura's website, with a replay available afterward.

Kura Oncology (NASDAQ: KURA) announced that its Compensation Committee granted inducement awards to 16 new employees on May 1, 2025. The awards consist of nonstatutory stock options to purchase 433,950 shares of common stock under the Company's 2023 Inducement Option Plan. The stock options have an exercise price of $6.49 per share, matching the company's closing price on May 1, 2025. The options will vest over four years, with 25% vesting after one year and the remaining balance vesting monthly over 36 months, contingent on continued employment. These grants were approved as inducement material for employment in accordance with Nasdaq Listing Rule 5635(c)(4).

Kura Oncology (KURA) reported significant progress in Q1 2025, highlighted by the submission of its first NDA for ziftomenib to treat adult patients with relapsed/refractory NPM1-mutant AML. The company earned a $45 million milestone payment from Kyowa Kirin for the NDA submission. Q1 financial results showed collaboration revenue of $14.1M, with a net loss of $57.4M. The company maintains a strong financial position with $703.2 million in pro forma cash. Key upcoming milestones include data presentations at ASCO and EHA, initiation of two Phase 3 trials in frontline AML settings, and expansion of clinical programs. First patients were dosed in the KOMET-015 Phase 1 trial for GIST treatment. The company's cash runway extends into 2027 and is expected to support ziftomenib commercialization through frontline AML combination setting.

Kura Oncology (KURA) has initiated dosing in KOMET-015, a Phase 1 clinical trial evaluating ziftomenib in combination with imatinib for patients with advanced gastrointestinal stromal tumors (GIST) who failed imatinib treatment. The trial aims to assess safety, tolerability, and preliminary antitumor activity.

Preclinical studies showed the combination demonstrates robust antitumor activity in both imatinib-sensitive and resistant GIST models through a synthetic lethal mechanism. With 4,000-6,000 new GIST cases diagnosed annually in the U.S. and 60% of patients developing imatinib resistance within two years, ziftomenib could potentially delay or overcome this resistance.

The KOMET-015 Phase 1a/1b trial will evaluate safety, determine recommended Phase 2 dosing, and measure endpoints including clinical benefit, overall response rate, progression-free survival, and overall survival. This marks the first clinical trial combining a menin inhibitor with standard GIST treatments.

Kura Oncology (KURA), a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, has scheduled its first quarter 2025 financial results announcement. The company will release its Q1 2025 results after U.S. market close on Thursday, May 1, 2025.

Management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT to discuss financial performance and provide a corporate update. Investors can access the live call via phone using the numbers (800) 245-3047 (domestic) or (203) 518-9765 (international) with conference ID: KURAQ1. A live webcast and replay will be available through the investor relations section of Kura's website.