Kura Oncology Inc Stock Price, News & Analysis

Kura Oncology (Nasdaq: KURA) and Kyowa Kirin announced FDA approval of KOMZIFTI (ziftomenib) on November 13, 2025 for adult patients with relapsed or refractory NPM1‑mutated acute myeloid leukemia (R/R NPM1‑m AML) with no satisfactory alternative options.

Approval is based on the KOMET‑001 trial (N=112): CR+CRh 21.4% (95% CI: 14.2, 30.2), median duration of CR+CRh 5.0 months, median time to first response 2.7 months. KOMZIFTI is the first once‑daily oral menin inhibitor approved; label includes a boxed warning for differentiation syndrome but no boxed warning for QTc prolongation.

Kura Oncology (Nasdaq: KURA) will participate in the Jefferies Global Healthcare Conference on November 19, 2025. The company is scheduled to present at 3:30 p.m. GMT / 10:30 a.m. ET / 7:30 a.m. PT.

A live audio webcast will be available in the Investors section of Kura Oncology's website, with an archived replay posted after the event.

Kura Oncology (Nasdaq: KURA) announced that on November 3, 2025 its Compensation Committee granted inducement nonstatutory stock options to a new non-executive employee under the company's 2023 Inducement Option Plan, as amended.

The grant totals 21,750 options with an exercise price of $9.77 per share (the closing price on November 3, 2025). Options vest over four years: 25% at one year then monthly over the following 36 months, subject to continued service, and are governed by the plan and a stock option agreement. The committee approved the award as an inducement in accordance with Nasdaq Listing Rule 5635(c)(4).

Kura Oncology (Nasdaq: KURA) reported third quarter 2025 results and a corporate update on Nov 4, 2025. Key clinical milestones include an FDA Priority Review for ziftomenib in R/R NPM1‑mutant AML with a PDUFA date of Nov 30, 2025, initiation and first‑patient dosing in the pivotal KOMET‑017 Phase 3 trials in frontline AML, and dosing in KOMET‑007 FLT3 cohort. Two oral ASH 2025 presentations will feature ziftomenib combination data. ESMO 2025 data highlighted activity for FTIs darlifarnib and tipifarnib in solid tumors. Financially, Kura reported $609.7M pro forma cash (including two $30M Kyowa Kirin milestones) and said cash should fund operations into 2027 and support KOMET‑017 topline results.

Kura Oncology (Nasdaq: KURA) announced on Nov 3, 2025 that it received a $30 million development milestone payment from Kyowa Kirin after dosing the first patient in the second of two frontline KOMET-017 Phase 3 trials of ziftomenib. This follows a prior $30 million milestone in October 2025 and brings total milestone receipts to $105 million to date. Kura stated it expects up to $315 million in additional near-term milestones under the collaboration.

KOMET-017 (NCT07007312) comprises two independent, global, randomized, double-blind, placebo-controlled Phase 3 trials evaluating once-daily oral menin inhibitor ziftomenib with both intensive and non-intensive chemotherapy in newly diagnosed NPM1-mutated or KMT2A-rearranged AML.

Kura Oncology (NASDAQ: KURA) and Kyowa Kirin will present updated clinical data for ziftomenib combined with venetoclax and azacitidine (ven/aza) from the KOMET-007 Phase 1a/b trial at the ASH 2025 Annual Meeting on December 8, 2025 in Orlando, FL.

The programs include: an updated analysis in relapsed/refractory NPM1-m or KMT2A-r AML and initial Phase 1b results in newly diagnosed NPM1-m AML. The abstracts used a June 2025 cutoff; ASH presentations will show more mature safety and response data with longer follow-up and additional evaluable patients. Presentation times are 10:45–11:00 AM ET (Oral #764) and 11:15–11:30 AM ET (Oral #766). Slides will be posted on Kura's publications page after the meeting.

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.