Authors of a pivotal NEJM paper describing Amgen’s Tavneos (avacopan) trial outcomes retracted the study after primary endpoint assessments for nine patients were “re-adjudicated” after database lock and trial unblinding. The retraction adds to ongoing scrutiny around trial conduct and accelerates regulatory and litigation attention for the ANCA vasculitis medicine. Amgen previously faced additional FDA pressure regarding trial data integrity and risk-benefit considerations, with the company commissioning an independent review of primary endpoint results and preparing hearing submissions. For sponsors and investigators, the retraction reinforces how changes made after lock and unblinding—if not disclosed—can undermine scientific and regulatory trust. The case is a high-profile signal that journal scrutiny is becoming a key part of the evidence durability lifecycle, not just a publication step.