Core Viewpoint - Kura Oncology has submitted its first New Drug Application (NDA) for ziftomenib to the FDA for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an NPM1 mutation, marking a significant milestone for the company [2][5]. Company Updates - The NDA submission for ziftomenib occurred on March 31, 2025, with a 60-day filing review period expected from the FDA, potentially leading to a six-month review if Priority Review is granted [5]. - Kura Oncology is preparing for two Phase 3 studies in the frontline setting and anticipates multiple clinical data readouts throughout the year [2][4]. - The first patients have been dosed in the Phase 1 trial of ziftomenib in combination with imatinib for gastrointestinal stromal tumors (GIST) [1][6]. Financial Highlights - Collaboration revenue from the partnership with Kyowa Kirin for Q1 2025 was $14.1 million, compared to no revenue in Q1 2024 [9]. - Research and development expenses for Q1 2025 were $56.0 million, up from $36.3 million in Q1 2024, while general and administrative expenses increased to $22.8 million from $18.2 million [9]. - The net loss for Q1 2025 was $57.4 million, compared to a net loss of $49.5 million in Q1 2024, with cash, cash equivalents, and short-term investments totaling $658.2 million as of March 31, 2025 [9][16]. Milestones and Future Plans - Kura expects to present data from the KOMET-001 Phase 1b/2 trial at the ASCO and EHA meetings in the second quarter of 2025 [9]. - The company plans to initiate two independent Phase 3 registration-enabling trials in the second half of 2025 [9][13]. - Kura anticipates receiving up to $375 million in additional milestone payments from Kyowa Kirin, following the $45 million milestone payment triggered by the NDA submission [4][5].