secwatch.observer — SEC 8-K summary
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Issuer:     NewAmsterdam Pharma Co N.V. (NAMS)
CIK:        0001936258
Form:       8-K
Filed at:   2024-12-10T23:59:59+00:00
Accession:  0001193125-24-273959
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

NewAmsterdam reports positive Phase 3 BROADWAY topline: 33% LDL-C reduction, 21% MACE reduction
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- Primary endpoint met: LS mean LDL-C reduction of 33% (p<0.0001) vs placebo at day 84 on top of maximally tolerated therapies.
- Observed 21% reduction in MACE (exploratory endpoint) at one year; hazard ratio 0.79 (95% CI 0.54-1.15).
- Obicetrapib well-tolerated: TEAEs 59.8% vs placebo 60.9%; discontinuation 11.1% vs 12.4%.
- NewAmsterdam plans to present additional BROADWAY data at upcoming medical meetings and discuss filings with regulators.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1936258/000119312524273959/0001193125-24-273959-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1936258/000119312524273959/d910195d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-273959

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