Kura Oncology: ziftomenib PDUFA set for Nov 30, 2025 (R/R NPM1-m AML)

The 8-K confirms the FDA has set a November 30, 2025 PDUFA target action date for ziftomenib monotherapy in relapsed/refractory NPM1-m AML. This is the next regulatory milestone for the asset ahead of potential approval.

Key facts

Filed: Nov 4, 2025, 11:35 AM
Event: PDUFA date set
Direction: Neutral
Company: KURAKura Oncology
Asset: ziftomenib
Source: SEC 8-K
Confidence: Sourced
Calendar: FDA decision (PDUFA) · Nov 30, 2025 · Outcome not recorded

Source excerpt

EX-99.1 2 kura-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Kura Oncology Reports Third Quarter 2025 Financial Results – KOMET 017 Phase 3 trials to evaluate ziftomenib in combination with intensive and non-intensive chemotherapy in frontline AML are accelerating; ziftomenib being investigated in settings representing more than 50% of AML patients – – Two oral presentations at 2025 ASH Annual Meeting on ziftomenib in combination with venetoclax / azacitidine chemotherapy in frontline and R/R NPM1 -m AML – – Clinical data at ESMO 2025 Congress highlight promise of second strategic program – FTIs darlifarnib and tipifarnib show promising safety profile and clinical activity with targeted therapies in solid tumors – – $609.7 million in pro forma cash, together with anticipated collaboration payments, expected to support ziftomenib AML program through topline results in KOMET-017 – – Management to host webcast and conference call today at 8:00 a.m. ET – SAN DIEGO, November 4, 2025 – Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported third quarter 2025 financial results and provided a corporate update. “Our momentum is accelerating across the ziftomenib program and our broader precision oncology pipeline,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer. “With the initiation of the pivotal KOMET-017 Phase 3 trials, we are execu

SEC 8-K