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Amgen's $3.7B all-cash acquisition of ChemoCentryx for TAVNEOS (avacopan) is heading toward a bust: sales hit $283M in FY2024, but a January 2026 FDA withdrawal request over data manipulation in the pivotal ADVOCATE trial—followed by a formal Notice of Opportunity for a Hearing—now threatens the drug's approval entirely, with Amgen contesting the action.
Amgen acquired ChemoCentryx for $3.7B, maker of Tavneos for vasculitis.
Amgen baulks at FDA's Jan 16, 2026 request to withdraw Tavneos; CEO Robert Bradway calls it 'an important and effective medicine' citing favourable…
FDA seeks to withdraw avacopan approval over alleged data manipulation and false statements; ChemoCentryx (Amgen subsidiary) given opportunity for a hearing.
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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.
75K US cases/yr · $2.0B Global AAV Market (2024)
ANCA-associated vasculitis (AAV) includes GPA and MPA, causing small vessel inflammation affecting kidneys, lungs, and other organs. Tavneos was first-in-class C5aR inhibitor but faces existential regulatory risk after FDA requested voluntary market withdrawal over ADVOCATE trial data integrity questions.
FDA requested voluntary withdrawal Jan 16, 2026; Amgen declined. CDER issued a formal Notice of Opportunity for a Hearing (91 FR 23278, pub. Apr 30, 2026) proposing to withdraw NDA 214487 over ADVOCATE re-adjudication of 9/331 patients (alleged data manipulation / untrue statements) and serious drug-induced liver injury incl. vanishing bile duct syndrome. TAVNEOS FY2024 sales $283M (+111% YoY) now face existential regulatory risk; Amgen requested a hearing.
Amgen completed $3.7B acquisition of ChemoCentryx, gaining Tavneos (avacopan), first oral complement C5a receptor inhibitor for ANCA-associated vasculitis.
Tavneos established as new standard of care in ANCA-associated vasculitis with growing physician adoption under Amgen's commercial infrastructure.
FDA/CDER issued a Notice of Opportunity for a Hearing (91 FR 23278) proposing to withdraw NDA 214487 for TAVNEOS (avacopan) over alleged ADVOCATE-trial data manipulation (re-adjudication of 9/331 patients), untrue statements of material fact, and serious drug-induced liver injury. Follows FDA's Jan 16, 2026 voluntary-withdrawal request, which Amgen declined. Amgen requested a hearing.
Original $3.7B (~77x LTM revenue) was aggressive for a single rare-disease asset. Thesis now broken: FDA proposed withdrawing TAVNEOS (Apr 2026) over alleged ADVOCATE data manipulation and serious liver injury; approval loss would impair the core asset.
| Deal | Year | Value | Outcome |
|---|---|---|---|
| Amgen Inc. / ChemoCentryx Inc. (this deal) | 2022 | $3.7B | 61 |
| Amgen Inc. / Immunex Corporation | 2002 | $16.0B | 92 |
| Amgen Inc. / Immunex Corporation | 2001 | $16.0B | 91 |
| Amgen Inc. / Micromet Inc. | 2012 | $1.2B | 88 |
| Amgen Inc. / Five Prime Therapeutics | 2021 | $1.9B | 78 |
| Amgen Inc. / Horizon Therapeutics plc | 2022 | $27.8B | 72 |
| Amgen Inc. / Otezla (from Celgene/BMS) | 2019 | $13.4B | 68 |
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