Biomea Fusion reports BMF-650 Phase 1 results with 1.5% to 3.2% weight reduction
On October 13, 2026, Biomea Fusion reported topline Phase 1 GLP-131 results for BMF-650, its investigational oral GLP-1 receptor agonist. In Cohorts 1-4, mean Day 29 weight reduction ranged from 1.5% to 3.2% versus 0.1% for pooled placebo, and the company reported no severe or serious adverse events among active-dose participants, but the results are preliminary, the sample sizes are small, and the company says longer-term toxicology studies are still needed before further development, which may include a partnership.
Key points
- Cohorts 1-4 (outpatient): mean Day 29 weight reduction of 1.5% to 3.2% versus 0.1% for pooled placebo.
- Cohort 5 (under confinement, 200 mg then 400 mg): 6.1% (6.2 kg) mean weight reduction at Day 29; the company says it should be interpreted separately because confinement appeared to affect eating behavior.
- No severe or serious TEAEs, TEAE-related dose modifications, or TEAE-related discontinuations across the 40 active-dose MAD participants; nausea occurred in 17.5% and vomiting in 7.5% across active cohorts.
- Longer-term toxicology studies are required; the company is positioning BMF-650 for a strategic partnership, which could include licensing, while its primary focus remains icovamenib.
The filing
Written by AI on Nov 9, 2026, 11:44 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on October 13, 2026.
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