BMF-219 (icovamenib)

COVALENT-111 study. 9/26/24- Lifted clinical hold. 12/17/24- Met primary endpoint. 10/6/25- 52-wk results reported. 12/5/25– Presented 52wk data at WCIRDC’25. 01/12/26:- 52-week icovamenib T2D data and GLP-1 add-on benefits reiterated; supports beta-cell health mechanism. 03/14/26:- Positive 52-week COVALENT-111 follow-up results showed durable glycated hemoglobin reductions and favorable safety. 03/24/26:- COVALENT-111 52-week data detailed and COVALENT-121 food-effect study completed, confirming favorable pharmacokinetics and safety. 03/31/26:- 52-week COVALENT-111 analysis: placebo-adjusted HbA1c -1.5% and -1.8%; no treatment-related serious adverse events. 05/05/26:- COVALENT-111 subgroup poster at ADA June 7; materials posted after June 5 embargo. 05/11/26:- PR No update.