secwatch.observer — SEC 8-K summary
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Issuer:     Biomea Fusion, Inc. (BMEA)
CIK:        0001840439
Form:       8-K
Filed at:   2026-10-13T21:35:08+00:00
Accession:  0001193125-26-420684
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

Biomea BMF-650 Phase 1: 1.5-3.2% weight loss in Cohorts 1-4 vs 0.1% placebo; Cohort 5 6.1% confounded
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- Mean Day 29 weight reduction 1.5% to 3.2% across MAD Cohorts 1-4 (200 mg+ QD) vs 0.1% pooled placebo; weekly loss ~0.97 kg at 200 mg or higher.
- Cohort 5 (200 mg x1 wk then 400 mg x3 wks) showed 6.1% (6.2 kg) mean weight loss at Day 29 but confinement cut placebo food intake to ~33%; results interpreted separately.
- Safety: across 5 active MAD cohorts (n=40) all TEAEs mild/moderate; no severe/serious TEAEs, no dose modifications or discontinuations; no ALT/AST increases.
- Cohort 5 GI events: nausea and vomiting each 12.5%, constipation 25%, diarrhea 0%; all Grade 1. Across all active cohorts: nausea 17.5%, vomiting 7.5%, constipation 10%, diarrhea 5%.
- BMF-650 needs longer-term toxicology studies; Biomea seeks strategic partnership/licensing; primary focus remains icovamenib in type 1 and type 2 diabetes.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1840439/000119312526420684/0001193125-26-420684-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1840439/000119312526420684/d158362d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-420684

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer