Needham has initiated coverage on NewAmsterdam Pharma Company N.V (NASDAQ:NAMS), a clinical-stage biopharma developing obicetrapib, an orally-dosed CETP inhibitor for lowering cholesterol.
In July, NewAmsterdam Pharma released topline data from the Phase 3 BROOKLYN trial, the first of four studies in NewAmsterdam's pivotal clinical development program, to evaluate obicetrapib in adult patients with heterozygous familial hypercholesterolemia whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy.
The study achieved the primary endpoint of LS mean reduction of in LDL-C on top of maximally tolerated lipid-modifying therapies at day 84 with a statistically significant reduction sustained at day 365.
Also Read: Analyst Confident In NewAmsterdam Pharma's Cholesterol Drug Despite Mixed Reactions To Study Results.
Obicetrapib lowered LDL-C by 36.3% on day 84 and 41.5% on day 365, compared to the placebo. The observed reductions in other biomarkers met statistical significance.
Needham highlights that Obicetrapib stands out from previous CETP inhibitors due to its lack of associated issues.
The upcoming phase 3 trial results, expected in Q4 2024 and Q1 2025, could validate Obicetrapib's significant LDL-C reduction and favorable safety profile, potentially reducing the risk of major adverse cardiovascular events (MACE) by over 15% in the PREVAIL CVOT trial, with results anticipated in the second half of 2026.
The analyst initiates with a Buy rating and a price target of $36.
If successful, Needham expects Obicetrapib to generate blockbuster sales of over $2 billion by targeting around 30 million patients.
In June 2024, NewAmsterdam announced a new US patent for Obicetrapib, protecting the drug until July 2043.
The company ended the second quarter with a cash position of $430.7 million.
Price Action: NAMS stock is up 0.12% at $16.69 at the last check Wednesday.
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