Positive Top-Line Results from KOMET-001
The Phase 2 registration-directed trial of ziftomenib in patients with relapsed/refractory NPM1-mutant AML achieved its primary endpoint, consistent with a targeted 20% to 30% CR/CRh rate, and the safety profile was consistent with prior reports.
Regulatory Progress for Ziftomenib
Alignment with FDA and EMA on potential pathways for accelerated approval in the US and Europe for ziftomenib in frontline AML, with plans for NDA submission in Q2 2025.
Strong Financial Position
Cash, cash equivalents, and short-term investments of $727.4 million as of December 31, 2024, expected to fund operations into 2027.
Collaboration Revenue Boost
Collaboration revenue from Kyowa Kirin partnership was $53.9 million for Q4 2024, compared to none in the corresponding quarter of 2023.
Future Prospects in Diabetes
Plans to nominate a next-generation menin inhibitor development candidate for use in diabetes in mid-2025, based on promising preclinical data.