secwatch.observer — SEC 8-K summary
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Issuer:     NewAmsterdam Pharma Co N.V. (NAMS)
CIK:        0001936258
Form:       8-K
Filed at:   2024-11-20T23:59:59+00:00
Accession:  0001193125-24-262125
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

NewAmsterdam Pharma reports positive Phase 3 TANDEM topline data; FDC lowers LDL-C 48.6% vs placebo
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- Fixed-dose combination of obicetrapib 10 mg and ezetimibe 10 mg achieved LS mean LDL-C reduction of 48.6% (p<0.0001) vs placebo at day 84.
- All co-primary endpoints met with statistical significance; FDC superior to both monotherapies (p<0.001).
- Over 60% of FDC patients saw >50% LDL-C reduction; ~71% achieved LDL-C <55 mg/dL.
- Safety well-tolerated; drug-related TEAEs 2.9% in FDC arm vs 3.9% placebo; no serious TEAEs.
- Data supports global regulatory filings for the FDC tablet.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1936258/000119312524262125/0001193125-24-262125-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1936258/000119312524262125/d868860d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-262125

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