Kura Oncology reported positive topline results from its KOMET-001 registrational trial, achieving its primary endpoint, and announced alignment with the FDA and EMA on key aspects of the KOMET-017 protocol for potential U.S. accelerated approval. The company also reported a significant increase in collaboration revenue due to its partnership with Kyowa Kirin.
KOMET-001 registrational trial in R/R NPM1-mutant AML achieved its primary endpoint.
Alignment reached with FDA and EMA on key aspects of the KOMET-017 protocol, including use of MRD-negative CR endpoint for potential U.S. accelerated approval pathway in frontline intensive chemotherapy trial.
Collaboration revenue from the Kyowa Kirin partnership for Q4 2024 was $53.9 million, compared to no revenue in 2023.
Net loss for Q4 2024 was $19.2 million, an improvement from a net loss of $42.8 million in Q4 2023.
Kura Oncology anticipates submitting an NDA for ziftomenib in R/R NPM1-m AML in Q2 2025 and initiating two independent Phase 3 registration-enabling trials in 1L AML in H2 2025. The company expects its current cash to fund operations into 2027.
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