Pharma BD Deal Intelligence
Amgen acquired ChemoCentryx for $52.00 per share in cash, ~$3.7 billion (announced Aug 4, 2022; closed Oct 20, 2022 via tender offer + merger), to obtain TAVNEOS (avacopan), the first-in-class oral complement C5a receptor inhibitor approved for ANCA-associated vasculitis (AAV). The asset's outlook has since deteriorated sharply: TAVNEOS posted $283M in FY2024 sales (+111% YoY), but on January 16, 2026 the FDA requested that Amgen voluntarily withdraw avacopan, and Amgen declined. On April 27-30, 2026 FDA's CDER issued a formal Notice of Opportunity for a Hearing (Federal Register 91 FR 23278) proposing to withdraw NDA 214487, on grounds that the pivotal ADVOCATE trial failed to demonstrate efficacy under the original analysis and that unblinded personnel re-adjudicated primary-endpoint results for 9 of 331 patients in a manner FDA characterizes as data manipulation and untrue statements of material fact, compounded by serious drug-induced liver injury cases (including vanishing bile duct syndrome). Amgen (CEO Robert Bradway) maintains TAVNEOS is 'an important and effective medicine' and requested a hearing. The deal's sole core asset now carries existential regulatory risk, putting the $3.7B price (77x LTM revenue at deal) under severe pressure.