The New England Journal of Medicine retracted the pivotal phase 3 Tavneos (avacopan) study article after primary endpoint assessments for nine patients were reportedly “re-adjudicated” following database lock and trial unblinding, without disclosure in the publication. The retraction compounds the regulatory pressure Amgen has faced over the trial’s conduct, particularly after FDA reassessments. Tavneos is approved for anti-neutrophil cytoplasmic antibody-associated vasculitis, and the retraction notice describes a decision pathway that diverged from standard disclosure expectations. The case also reopens litigation context tied to earlier FDA concerns about trial data and Amgen’s defense posture. For the sector, the development is a high-salience reminder that publication-level integrity can become a parallel pressure point to regulator-led action—especially for rare-disease programs under heightened scrutiny.