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Biomea Fusion receives FDA IND clearance for BMF-219 in type 2 diabetes; expands COVALENT-111 to US sites
Biomea Fusion, Inc.
- FDA cleared IND for BMF-219 (covalent menin inhibitor) in type 2 diabetes; will activate US sites in ongoing COVALENT-111 study.
- Phase I portion completed with favorable safety, PK, and PD profile.
- Phase II portion evaluating BMF-219's ability to restore beta-cell health and long-term glycemic control.
- Initial Phase II data expected in first half of 2023.
- Company to host investor conference call on December 15, 2022 at 4 PM EST.