Kura Oncology Reports Komzifti Q3 Revenue of $13.9M as FDA Aligns on Darlifarnib Study
The US company says net sales of its NPM1-mutated AML therapy rose 53%, and it has agreed a registrational design with the FDA for darlifarnib in HRAS-mutant salivary gland cancer.
Kura Oncology reported third-quarter 2026 results on 10 November, citing net revenue of $13.9 million from Komzifti (ziftomenib). The product is indicated for relapsed or refractory acute myeloid leukaemia (AML) with an NPM1 mutation. The company's headline put the increase at 53%.
On the pipeline, Kura said it has reached alignment with the US Food and Drug Administration on a registrational study of darlifarnib in HRAS-mutant salivary gland cancer. The study is planned as a single-arm trial of roughly 40 patients and is due to start in the first half of 2027.
On financing, the company cited an agreement with Oberland Capital for up to $300 million, of which $55 million was received at closing. Kura ended the quarter with $492.1 million in cash.
The summary available does not include further detail on the comparison period for the 53% growth, the trial's endpoints or the staging of the remaining Oberland funds.
What it means for your team
- Regulatory teams tracking oncology development can note that the FDA has agreed a single-arm, roughly 40-patient design as registrational for darlifarnib in HRAS-mutant salivary gland cancer, a small-population approach.
- Market-access teams may watch Komzifti's early commercial uptake in relapsed/refractory NPM1-mutated AML, with Q3 net revenue at $13.9 million.
- Pharmacovigilance and clinical-operations teams should expect a new study start in the first half of 2027, with safety data collection to follow.
Company's press release (SEC filing): Kura Oncology, Inc. ↗
Article written by VigiEye from the official source (Kura Oncology, Inc.). Claims are the company's own. AI-assisted; check the source before acting.