CHMP Backs Obicetrapib, Paving Way for EU Approval in 2H26
NAMS sits 48% above its 52-week low of $21.135.
Summary
The CHMP positive opinion is a major regulatory win for obicetrapib, recommending EU marketing authorization for both the monotherapy and fixed-dose combination. This follows the 8-K filed today and builds on positive Phase 3 data from BROADWAY, BROOKLYN, and TANDEM. The European Commission decision is expected in the second half of 2026, and approval would unlock a large European market where Menarini holds commercialization rights. NewAmsterdam stands to receive tiered double-digit royalties and up to €833 million in milestones. With the PREVAIL cardiovascular outcomes trial fully enrolled, this de-risks the regulatory path and strengthens the commercial outlook.
At the time of this announcement, NAMS was trading at $31.35 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $3.6B. The 52-week trading range was $21.14 to $42.21. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.