FDA lifts clinical hold on Biomea Fusion's BMF-219 for type 2 and type 1 diabetes trials

Biomea Fusion, Inc.

FDA lifted clinical hold on Phase I/II trials COVALENT-111 (type 2 diabetes) and COVALENT-112 (type 1 diabetes) as of Sept 26, 2024.
CEO stated safety signals from Phase 2a Escalation Study did not translate to Phase 2b Expansion Study; no confirmed serious liver injury.
Company expects to announce a third development candidate (oral GLP-1 agonist) in Q4 2024.
Topline Week 26 data from ~200-patient Phase 2b COVALENT-111 and Phase 2a COVALENT-112 (20 patients) expected Q4 2024.

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