- The FDA has signed off Biomea Fusion Inc's BMEA Investigational New Drug application to begin a Phase 1 trial of BMF-219, a selective irreversible menin inhibitor.
- The trial will include adult patients with relapsed or refractory acute leukemia, including those with an MLL/KM2TA gene rearrangement or NPM1 mutation.
- The trial will assess the safety, pharmacokinetics (PK), and pharmacodynamic (PD) profile in adult patients.
- Related content: Benzinga's Full FDA Calendar.
- Price Action: BMEA shares were up 5.64% at $11.23 before the trading was halted during the market session on the last check Thursday.
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