- NewAmsterdam Pharma's pivotal PREVAIL trial is **fully enrolled** and tracking well, with completion expected by the **end of 2026** and data readout anticipated towards the **end of 2026 or early 2027**.  **[1936258_2162527_0]** **[1936258_2162527_1]**  The company has strong conviction that the **21% MACE reduction** observed in the BROADWAY trial will translate to PREVAIL.  **[1936258_2162527_0]** 
- Regulatory applications for obicetrapib's monotherapy and fixed-dose combination have been accepted in Europe, with approvals and a launch by partner Menarini expected in the **second half of 2026**.  **[1936258_2162527_1]** 
- Obicetrapib is positioned as the **only CETP inhibitor** in the market, offering a differentiated profile by significantly lowering small LDL particles and lipoprotein(a), and demonstrating an effect on **Alzheimer's disease biomarkers**.  **[1936258_2162527_0]** **[1936258_2162527_3]** **[1936258_2162527_4]** **[1936258_2162527_7]** 
- The drug's efficacy, including a **21% MACE reduction** in the BROADWAY trial, is supported by its impact on multiple lipid parameters, and it maintains a **very clean safety profile**.  **[1936258_2162527_2]** **[1936258_2162527_7]**

NewAmsterdam Pharma Updates on Obicetrapib Clinical Development and Market Strategy

- NewAmsterdam Pharma (NAMS) reported positive **Phase 3 data** for obicetrapib, demonstrating strong efficacy in LDL lowering and safety, with a **21% MACE benefit** (four-point MACE reduction).  **[1936258_tx_379076_0]** 
- The company has filed for **EMA approval in Europe**, which was accepted approximately **two weeks prior** to the document date.  **[1936258_tx_379076_0]**  The **PREVAIL trial**, a nearly **10,000-patient outcomes study**, is fully enrolled and on track to finish **late next year**.  **[1936258_tx_379076_0]** **[1936258_tx_379076_1]** 
- Obicetrapib also showed a new benefit in **APOE4 patients** from the Broadway trial, indicating a lowering of pTal217, a biomarker of amyloid pathology in the brain, with significant improvements in all biomarkers for E4 homozygotes.  **[1936258_tx_379076_0]**  The company plans to discuss this data with the FDA for potential future studies.  **[1936258_tx_379076_3]** 
- NAMS is committed to **launching the drug in the US on its own** but will actively pursue partnerships for Japan, China, and other OUS geographies.  **[1936258_tx_379076_9]** 
- The company holds **IP protection** for obicetrapib until **2043**.  **[1936258_tx_379076_8]**

NewAmsterdam Pharma Discusses Obicetrapib's Progress, Including Alzheimer's Benefit and Commercial Strategy

- NewAmsterdam Pharma Company N.V. (NAMS) filed an 8-K on **September 2, 2025**, furnishing an **updated corporate investor presentation**.  **[1936258_0000950170-25-112345_nams-20250902.htm:0]** 
- The presentation highlights obicetrapib's efficacy, including **35-40% LDL-C lowering** as monotherapy, **~50% LDL-C lowering** with ezetimibe, and **~45% Lp(a) lowering**.  **[1936258_0000950170-25-112345_nams-ex99_1.htm:4]**  Exploratory analysis also indicated a **21% reduction in MACE** at 1-year.  **[1936258_0000950170-25-112345_nams-ex99_1.htm:4]** 
- The company reported **~$780 million in cash** as of **Q2 2025**, secured to support a potential US commercial launch.  **[1936258_0000950170-25-112345_nams-ex99_1.htm:4]** 
- NewAmsterdam Pharma plans for **EMA regulatory submission in 2H 2025** for obicetrapib monotherapy and fixed-dose combination products.  **[1936258_0000950170-25-112345_nams-ex99_1.htm:10]** 
- Furthermore, an Alzheimer’s biomarker sub-study showed obicetrapib led to a **significant reduction in p-tau217 progression** over 12 months, with a **2.99% benefit** in the full analysis set and a **20.5% benefit** in ApoE4 homozygotes.  **[1936258_0000950170-25-112345_nams-ex99_1.htm:12]**

NewAmsterdam Pharma Co (NAMS)