FDA liver injury scrutiny on Tavneos is likely triggering increased selling pressure and heightened volatility in Amgen stock.

Amgen posted strong execution with Q4 revenues up 9% on 10% volume growth and full-year double-digit EPS growth, driven by key medicines that more than offset declines in mature products. The late-stage pipeline includes phase 3 MariTide and new phase 1b zoci studies, supporting management’s projection of ~$37.4 B revenue and $8.2 B earnings by 2028, despite a slight near-term EPS dip, while the company sustains capacity for growing dividends with a 13-year increase streak.

FDA warnings over Tavneos-related liver injuries and advised liver panel testing highlight growing regulatory constraints, while biosimilar launches threaten Prolia and Xgeva revenues and pricing headwinds intensify competitive pressure; oncology collaborations aim to diversify market access amid these challenges.

Bullish narratives around 2026 Fed rate cuts fueling biotech M&A, AI-accelerated drug discovery, and small-cap breakouts have investors upbeat, with enthusiasm driven by Amgen’s advancing pipeline; yet a Zacks hold rating, Tavneos safety overhang, and modest P/E discount temper the exuberance.