NewAmsterdam Pharma Company N.V.

At the Cantor conference NewAmsterdam Pharma outlined the upcoming critical phase for Obicetrapib, with an interim analysis of the PREVAIL study expected in early 2025 and an anticipated European approval following a positive CHMP recommendation. Management emphasized broad clinical effects beyond LDL reduction and plans phased launches through partner Menarini alongside a moderate expansion of its commercial infrastructure. The stock fell to $22.14 after the presentation, but the company stresses disciplined spending and expects R&D costs to decline through 2027. » Więcej na de.investing.com

At the Wells‑Fargo healthcare conference, NewAmsterdam emphasized the multiple effects of Obicetrapib — strong LDL reduction, HDL increase, Lp(a) reduction and potential benefits on diabetes and Alzheimer biomarkers — and highlighted positive BROADWAY data showing a 21% relative risk reduction for 4‑point MACE. The approval‑relevant phase‑III trial PREVAIL has been redesigned; an interim analysis is expected in Q4 2024 and a DSMB recommendation in Q1 2027. A U.S. regulatory filing and market launch are planned 12–18 months after PREVAIL completion. No financial figures were disclosed; management views Obicetrapib as a complementary therapy to PCSK9 treatments and announced further studies such as RUBIN (diabetes) and SPINOZA (Alzheimer). » Więcej na de.investing.com