secwatch.observer — SEC 8-K summary
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Issuer:     NewAmsterdam Pharma Co N.V. (NAMS)
CIK:        0001936258
Form:       8-K
Filed at:   2025-05-07T23:59:59+00:00
Accession:  0001193125-25-114456
Event type: other_material
Sentiment:  positive
Materiality: 0.90
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud

NewAmsterdam Pharma Reports Phase 3 BROADWAY and TANDEM Data Published in NEJM and Lancet
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- BROADWAY trial showed 33% LDL-C reduction (p<0.0001) vs placebo and a 21% relative reduction in MACE (HR=0.79).
- TANDEM trial fixed-dose combination of obicetrapib and ezetimibe achieved 48.6% LDL-C reduction vs placebo (p<0.001).
- Pooled Lp(a) analysis across three Phase 3 trials showed a median placebo-adjusted reduction of 45% at 12 weeks.
- Obicetrapib plus moderate statins lowered LDL-C by 69% (atorvastatin 20 mg) and 64% (rosuvastatin 10 mg) in a Phase 2 trial.
- Phase 2 data showed synergy in plaque prevention: combination of obicetrapib and ezetimibe reduced plaque formation by 98% vs 78% independently.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1936258/000119312525114456/0001193125-25-114456-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1936258/000119312525114456/d905689d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-114456

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