AMGN · 10-Q · 2026Q2 · Full report

Regulatory Approval Milestones

AMGEN INC · 2026-08-05 · Importance 57 · Surprise 60 · In source text

On April 27, 2026, FDA’s Center for Drug Evaluation and Research proposed withdrawing approval of TAVNEOS in the United States. The proposal followed a March 2026 Drug Safety Communication concerning serious, including fatal, drug-induced liver injury cases and alleged insufficient evidence of effectiveness and untrue material statements in the original application. Amgen requested a hearing on June 1, 2026 and submitted supporting real-world evidence and independently re-adjudicated study data on July 23, 2026. The $2.4 billion TAVNEOS intangible asset, including $2.3 billion related to the U.S. market, remained recoverable at June 30, 2026, but further cash-flow changes could impair recovery.

Key facts

• On April 27, 2026 CDER issued a proposal to withdraw approval of TAVNEOS and on April 30, 2026 FDA posted a notice proposing to withdraw approval and announced an opportunity to request a hearing source
• On June 1, 2026 Amgen requested a hearing on the FDA proposal to withdraw approval of TAVNEOS and submitted additional information supporting the request on July 23, 2026 source
• TAVNEOS developed-product-technology rights carrying value as of June 30, 2026: $2.4 billion total, with $2.3 billion related to the U.S. market source
• Amgen announced in June 2026 that the European Commission granted marketing authorization for IMDYLLTRA as a monotherapy to treat adults with extensive-stage small cell lung cancer following progression after first-line platinum-based chemotherapy. source

Impact estimates