The New England Journal of Medicine has retracted Tavneos (avacopan) pivotal phase 3 study data after an FDA investigation concluded primary endpoint assessments were readjudicated after database lock and trial unblinding without disclosure in the original article. The retraction deepens Amgen’s challenge as the FDA reassesses the drug’s risk-benefit profile and pushes toward market withdrawal. Tavneos was approved in 2021 for ANCA-associated vasculitis; the pivotal trial work traces back to ChemoCentryx before its $3.7 billion sale to Amgen. Earlier, FDA staff already raised concerns with the study conduct, which contributed to turmoil for investors. The retraction sets up a more complicated dispute path for Amgen, as the company resists a withdrawal and gears for an FDA hearing, including sharing endpoint re-adjudication work with regulators.