NewAmsterdam Pharma is a late-stage company developing obicetrapib, a once-daily pill that lowers LDL cholesterol; it is approved in the EU, where partner Menarini sells it, and is not approved in the U.S.
NewAmsterdam's obicetrapib, an oral CETP inhibitor, cut LDL cholesterol by about 50% with ezetimibe in Phase 3 and won European approval in September, partnered with Menarini. The case turns on whether PREVAIL, a trial of more than 9,500 patients, shows fewer heart attacks, strokes and cardiovascular deaths; earlier CETP inhibitors failed or showed small benefits. An interim result is expected in the first quarter of 2027, and NewAmsterdam says its $678.3 million in cash will last through the PREVAIL readout.
Thesis checklist
0 risks need attention
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Next decision point
Tests: PREVAIL shows fewer cardiovascular events
Does PREVAIL stop early because obicetrapib clearly reduces major cardiovascular events?
Strong, inconclusive and weak outcomes
What to look for in the result and how each would move the checklist
Price and material events
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Obicetrapib won EU approval as Ubeslo and Evlarco, sold in Europe by partner Menarini; NewAmsterdam expects the PREVAIL cardiovascular outcomes interim analysis result in the first quarter of 2027
CHMP positive opinion in hand, European launch imminent — PREVAIL CVOT outcome determines whether obicetrapib becomes a cardiovascular franchise or a niche lipid drug
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Disease areas: Neurology and pain, Obesity, diabetes and heart disease
Catalyst calendar · Upcoming FDA decisions · Thesis changes
Competitive landscape
12 peers tracked
Cash: Market-data provider estimate; measurement period unavailable.
Debt: Market-data provider estimate; a complete comparable filing balance is unavailable.
Quarterly burn: Estimated from trailing free cash flow; measurement period unavailable.
Net cash and estimated runway require verified matching measurement periods. Missing debt components are not assumed to be zero.
Runway: No underlying guidance available.