AMGN · 8-K · 20260804PR000124
Regulatory Risk
AMGEN INC · 2026-08-04 · Importance 47 · Surprise 60 · In source text
Amgen continues discussions with the U.S. Food and Drug Administration regarding the Center for Drug Evaluation and Research’s request to voluntarily withdraw TAVNEOS from the U.S. market. The company requested an FDA hearing on June 1, 2026 and submitted supporting materials on July 23, 2026. Amgen stated that the materials support a favorable benefit-risk profile for TAVNEOS in patients with ANCA-associated vasculitis.
Key facts
- TAVNEOS FDA: the Company continues to engage the FDA regarding the Center for Drug Evaluation and Research’s request to voluntarily withdraw TAVNEOS from the U.S. market; on June 1, 2026 the Company requested a hearing and submitted supporting materials to the FDA on July 23, 2026. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | negative | contingent | — | TAVNEOS FDA: the Company continues to engage the FDA regarding the Center for Drug Evaluation and Research’s request to voluntarily… |