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Achieved majority share of new patient starts in the relapsed/refractory NPM1-mutant AML menin inhibitor market within the second full commercial quarter, despite being second to market.

Management attributes rapid adoption to a differentiated product profile characterized by predictable safety, dosing convenience, and lack of meaningful myelosuppression when combined with intensive chemotherapy.

Strategic focus is shifting toward establishing Ziftomenib as a foundational therapy through combinations with standards of care, supported by frontline data showing a 96% ORR in certain populations.

Darlifarnib is emerging as a second wholly owned strategic pillar, demonstrating the ability to enhance targeted therapy backbones in renal cell carcinoma and KRAS-mutated solid tumors.

Commercial execution is driven by high engagement with over 90% of top-priority AML accounts and successful navigation of market access, covering over 95% of lives.

Performance in the quarter was bolstered by physician-initiated combination use, which accounted for approximately 40% of new patient starts, signaling future treatment paradigm shifts.

Anticipate multiple clinical updates in the second half of 2026, including preliminary data for Ziftomenib combinations with gilteritinib and quizartinib.

The pivotal KOMET-017 Phase 3 trial remains on track for top-line results in 2028, utilizing a 'one-stop-shop' design to accrue both intensive and non-intensive chemotherapy patients.

Plan to initiate a darlifarnib platform study in second-line or later KRAS-mutant pancreatic cancer in the first half of 2027.

Current cash reserves and anticipated collaboration payments are expected to fund the Ziftomenib AML program through its first Phase 3 readout in 2028.

Management intends to maintain disciplined capital allocation, prioritizing registrational paths for both franchises while remaining open to selective strategic collaborations.

Reported $9.1 million in net product revenue for COMZIFTI, exceeding internal expectations for the second full quarter of launch.

Maintained collaboration revenue guidance of $45 million to $55 million for 2026, reflecting non-cash accounting for the Kyowa Kirin partnership.

R&D expenses slightly decreased year-over-year, reflecting a disciplined approach to pipeline expansion despite increased clinical activity.

Identified a potential total addressable market of $7 billion for Ziftomenib across the AML treatment continuum, assuming successful frontline expansion.

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Management clarified that while competitors may claim high overall starts, Kura holds the majority in the specific NPM1-mutant segment, which is the larger commercial opportunity.

Noted a 35% quarter-over-quarter growth in new patient starts and a 60% growth in total prescriptions, contrasting with a perceived decline in competitor starts.

Management believes up to 50% of AML cases may be menin-dependent due to high MEIS1 expression, expanding the potential patient population beyond current genetic markers.

Early clinical signals, including a complete response in a CEBPA/RUNX1 patient, support the exploratory analysis of broader menin-dependent AML subtypes.

Management prefers to retain full ownership of darlifarnib at this stage to maximize value, noting its potential as a 'blockbuster' asset alongside Ziftomenib.

The timing of investment decisions for darlifarnib registrational studies is designed to align with the 2028 Ziftomenib Phase 3 data readouts.

Approximately 40% of new starts are in combination with venetoclax, azacitidine, or FLT3 inhibitors, which management views as a validation of the drug's 'practical fit'.

While promoting only the monotherapy label, Kura is accelerating data generation for these combinations to support physician choice and future label expansions.