---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-183710"
form_type: "8-K"
ticker: "BMEA"
cik: "0001840439"
company_name: "Biomea Fusion, Inc."
filed_at: "2026-04-28T23:59:59+00:00"
generated_at: "2026-05-15T03:10:15.260088+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Biomea Fusion reports Phase 2 COVALENT-112 positive topline: 52% C-peptide increase in early T1D

## Summary
- In patients diagnosed within 3 years, icovamenib 200mg QD for 12 weeks increased mean C-peptide AUC by 52% (p<0.001, n=5) at Week 12; effect sustained with ~7% decline from baseline at Week 52.
- Dose response observed; longer-standing T1D (3-15 years) preserved C-peptide through Week 52 with only modest decline.
- Company plans Phase 2 trial with extended dosing (6-12 months) plus immunosuppressant, to start H2 2026 at four U.S. academic centers.
- Study enrollment interrupted due to FDA clinical hold (resolved); data reflects about half intended population; no placebo control completed.
- Icovamenib generally well tolerated; comprehensive data to be presented at ADA Scientific Sessions in June 2026.

## SEC filing metadata
- accession: 0001193125-26-183710
- form_type: 8-K
- ticker: BMEA
- cik: 0001840439
- company_name: Biomea Fusion, Inc.
- filed_at: 2026-04-28T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1840439/000119312526183710/0001193125-26-183710-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1840439/000119312526183710/d142809d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-183710
- JSON: https://secwatch.observer/filing/0001193125-26-183710.json
- Plain text: https://secwatch.observer/filing/0001193125-26-183710.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.