Kura Oncology (KURA) reported accelerating commercial uptake for its acute leukemia drug KOMZIFTI at the 12th Annual Cantor Fitzgerald Global Healthcare Conference on September 9, while unveiling plans to spin out a diabetes-focused venture backed by its menin inhibitor platform.
CEO Troy and Chief Commercial Officer Brian described KOMZIFTI’s second full quarter on the market as showing meaningful share gains among new patient starts in NPM1-mutated acute myeloid leukemia. The drug captured majority share in that cohort, up from roughly 40% in the second quarter, and more than 95% of patients are now covered within six months of treatment start.
The company highlighted a differentiated safety profile for ziftomenib compared with competing therapies, which have reported severe thrombocytopenia rates of 20% to 30%. A QTc warning remains on the label, but management said removing it is not an immediate priority because doing so would require randomized clinical data.
CFO Jennifer Fulk noted Kura’s stock traded around $11.39 on November 9, with the company valued at approximately $1.09 billion. Over the trailing twelve months, Kura reported a loss per share of $3.36 and a current ratio of 4.73. Shares have returned 56% over the past year and 33% over the last six months.
Troy outlined the total addressable market for relapse-refractory NPM1-mutated acute leukemia at $350 million to $400 million, assuming an average treatment duration of about six months. He described the broader acute leukemia market as roughly $7 billion and projected potential peak sales for ziftomenib of about $3 billion. Darlifarnib, a farnesyl transferase inhibitor, was characterized as addressing a similarly sized or larger opportunity in kidney and pancreatic cancer.
Kura also confirmed it expects four major clinical data updates in the fourth quarter, including preclinical data on its Caspian-developed compound KO-7246, to be presented at the European Association for the Study of Diabetes meeting in Milan.
The Phase I-B study combining darlifarnib with cabozantinib in kidney cancer is underway, with a separate Phase I-B evaluation pairing darlifarnib with daraxonrasib in pancreatic cancer planned to begin in 2025.
Initial Phase III results from the KOMET-017 trial, which tests ziftomenib versus standard care in an intensive chemotherapy cohort, are expected in 2028. The trial evaluates both intensive treatment paths using 7+3 chemotherapy and non-intensive approaches combining azacitidine and venetoclax.
Troy described a key strategic advantage of the intensive arm: it allows physicians to clear leukemia and maintain patients on once-daily ziftomenib continuation therapy, potentially avoiding the need for allogeneic stem cell transplant, which carries a 20% to 25% mortality risk. The company has named Caspian Therapeutics as a new spinout entity, with Kura shareholders retaining approximately 50% ownership. Caspian will pursue menin inhibitors as disease-modifying therapies in diabetes by targeting pancreatic beta islet cells to re-enter the cell cycle and proliferate.
