Academic authors retracted a pivotal phase 3 paper for Amgen’s Tavneos (avacopan) from The New England Journal of Medicine after the primary endpoint assessments for nine patients were reportedly re-adjudicated following database lock and unblinding. The retraction notice said the re-adjudication was not disclosed and was inconsistent with proper research conduct. Tavneos was approved by FDA in 2021 for ANCA-associated vasculitis, originally developed by ChemoCentryx and later sold to Amgen. The retraction adds to regulatory pressure described as part of Amgen’s defense efforts against potential FDA action related to trial conduct and risk-benefit considerations. The episode raises additional diligence expectations for investigators, data governance, and endpoint adjudication transparency—especially in high-stakes pivotal programs.