Biomea Fusion, Inc. BMEA
Biomea Fusion, Inc. (Nasdaq: BMEA) is a cardio-renal-metabolic drug developer. Its lead program, icovamenib (BMF-219), is in Phase 2 for Type 2 diabetes (also type 1 diabetes studied).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| icovamenib | Type 2 diabetes (COVALENT-211, COVALENT-212 Phase II ongoing) | small molecule | Phase 2 |
| BMF-650 | Obesity (oral GLP-1 receptor agonist) | small molecule | Phase 1 |
| BMF-500 | Oncology (covalent FLT3 inhibitor) | small molecule | Phase 1 |
Recent results and decisions
- Oct 13, 2026mixed Phase 1 MAD: mean Day 29 weight loss 1.5-3.2% vs 0.1% placebo in Cohorts 1-4; Cohort 5 (confinement, one-step titration to 400 mg) 6.1% but similar loss in two placebo patients; low GI adverse events.
In Cohorts 1-4, mean Day 29 weight reduction ranged from 1.5% to 3.2%, compared with 0.1% for pooled placebo from those cohorts.
Filing - Oct 13, 2026positive BMF-650 Phase 1 MAD study showed mean weight reduction of 1.5% to 3.2% at Day 29 across four outpatient cohorts with no severe TEAEs or discontinuations.
Mean weight reduction ranged from 1.5% to 3.2% at Day 29 across Cohorts 1-4, compared with 0.1% for pooled placebo.
Filing - Apr 28, 2026positive Phase II topline: 52% mean C-peptide AUC increase at Week 12 (p<0.001) in 200 mg Cohort 1 (n=5), largely preserved at Week 52 (~7% decline); small study, no formal primary endpoint stated.
Observed 52% increase in mean C-peptide AUC at Week 12 (p < 0.001) in Cohort 1 patients dosed at 200 mg (diagnosed within 0–3 years; n=5), a magnitude of improvement not commonly reported in published T1D studies
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
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- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 cardio-renal-metabolic companies
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Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.