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Biomea’s early oral GLP-1 data leave investors waiting for stronger evidence

Biomea Fusion reported Phase 1 results for BMF-650, an investigational once-daily oral small-molecule GLP-1 receptor agonist, and said the data could support discussions with potential partners. In four outpatient dose cohorts, average weight loss after 29 days ranged from 1.5% to 3.2%, versus 0.1% for pooled placebo. The highest-dose cohort reported 6.1% average loss, but it was small and conducted under confinement; Biomea cautioned that the setting may have influenced eating behavior. Among 40 participants receiving active doses, reported adverse events were mild or moderate, with no serious events, related dose changes, or discontinuations. The short study and small sample mean the safety and weight-loss findings are preliminary. Investors appeared unconvinced: the stock fell after the release, reflecting questions about the modest outpatient results, the interpretation of the standout confined-cohort result, and the candidate’s prospects in a crowded obesity-drug market. ...

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