Every material Form 8-K NewAmsterdam Pharma Co N.V. has filed with the SEC since August 14, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
NewAmsterdam Pharma announced that it dosed the first participant in SPINOZA, a Phase 2b trial evaluating obicetrapib in about 400 people with preclinical Alzheimer's disease. The trial will randomize participants 1:1 to obicetrapib 10 mg or placebo for 52 weeks, with the primary endpoint being change in plasma p-tau217 at Week 52. The filing contains no financial results, so the news is a clinical development milestone rather than a change in the company's reported performance.
First participant dosed in SPINOZA, announced September 29, 2026
Trial plans about 400 participants, randomized 1:1 to obicetrapib 10 mg or placebo for 52 weeks
Primary endpoint is change from baseline to Week 52 in plasma p-tau217
Builds on BROADWAY Alzheimer's biomarker analysis, which showed statistically significant lower p-tau217 changes versus placebo over 12 months (p=0.025 in the full analysis set)
The European Commission granted marketing authorization for Ubeslo and Evlarco, obicetrapib-based treatments for primary hypercholesterolaemia or mixed dyslipidaemia, marking the first regulatory approval of obicetrapib worldwide. The company's partner Menarini holds European commercialization rights, and the approvals trigger milestone payments in the mid-teens of millions of euros, with up to an additional €833 million available on future milestones.
Approvals cover all EU Member States, Iceland, Liechtenstein and Norway
Ubeslo is obicetrapib 10 mg monotherapy; Evlarco is 10 mg obicetrapib plus 10 mg ezetimibe
EC requires a post-authorization efficacy study and final results from the PREVAIL cardiovascular outcomes trial
Menarini milestone payments in the mid-teens of millions of euros triggered by the authorizations
NewAmsterdam Pharma appointed Robert W. Gunning as its principal accounting officer on August 10, 2026, succeeding Louise Kooij, whose previously announced departure takes effect August 31, 2026. Gunning joined the company as Vice President, Controller on the same day, and his offer letter sets a $375,000 base salary and a 30% target bonus.
Robert W. Gunning, age 55, appointed principal accounting officer on August 10, 2026
Succeeds Louise Kooij, whose departure is effective August 31, 2026
Offer letter dated July 24, 2026: $375,000 base salary, 30% target bonus, 3,200 RSUs and options on 14,000 shares
Previously served as Vice President Finance and Corporate Controller at Y-mAbs Therapeutics from April 2022 to April 2026
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.
Only material 8-Ks get a brief: results, deals, executive changes, restructuring, impairments, delisting notices, restatements, cybersecurity incidents and other disclosed events. Routine filings (vote results, exhibits only) are skipped. Every NewAmsterdam Pharma Co N.V. filing is on SEC EDGAR ↗. 8-K briefs of other companies →