EX-99.1 2 nams-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 NewAmsterdam Pharma and Menarini Group Receive Positive CHMP Opinion Recommending Marketing Authorization for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Combination) - Positive CHMP opinion supports potential commercialization of obicetrapib monotherapy and obicetrapib/ezetimibe fixed-dose combination in Europe - - Recommendation based on positive Phase 3 BROADWAY, BROOKLYN, and TANDEM data - - European Commission decision expected in 2H26 - Naarden, the Netherlands, Miami, USA, and Florence, Italy; July 24, 2026 - NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, along with partner Menarini Group (“Menarini”), today announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has adopted a positive opinion recom…
Open exhibit ↗Current Report · Items 8.01, 9.01 · 8-K
NewAmsterdam Pharma Company N.V.
NAMSNASDAQEQUITYCurrent
Other Events
Item 8.01 Other Events. On July 24, 2026, NewAmsterdam Pharma Company N.V. (the “Company”) issued a press release announcing that the Company and the Menarini Group have received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency recommending marketing authorization for Ubeslo® (obicetrapib monotherapy) and Evlarco® (obicetrapib plus ezetimi…
Company context
NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient therapy that lowers LDL-C while advancing innovation beyond a single marker to better address cardiovascular risk. In multiple phase 3 trials, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated.