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Amgen Shares Slide on FDA Setback and Enbrel Weakness, Pressuring Dow

Amgen stock fell nearly 2% Monday, pressured by an FDA request to withdraw rare-disease drug Tavneos and a sharp 48% quarterly drop in Enbrel sales. The decline weighed on the price-weighted Dow Jones Industrial Average.

StockTi Editorial · · 2 min read · 2 views
Amgen Shares Slide on FDA Setback and Enbrel Weakness, Pressuring Dow
Mentioned in this article
AMGN $384.32 +4.49% XLV $157.71 +1.85%

Amgen shares declined 1.8% to $377.28 during Monday's afternoon session, retreating from Friday's close of $384.32. The biopharmaceutical company's stock was among the worst performers in the Dow Jones Industrial Average, with its high share price amplifying its negative impact on the price-weighted index.

Regulatory and Commercial Headwinds

The downturn followed significant challenges for two key products. The U.S. Food and Drug Administration has requested a voluntary withdrawal of Tavneos, a rare-disease therapy, citing concerns about trial data and potential liver safety. Amgen has informed regulators it does not intend to withdraw the drug while seeking a resolution.

Separately, fourth-quarter sales of autoimmune treatment Enbrel plummeted 48%, driven by lower net selling prices following Medicare Part D changes and increased participation in the 340B discount program. The company also anticipates steeper declines for bone drugs Prolia and Xgeva in 2026 as biosimilar competition intensifies globally.

Broader Market Context

Healthcare stocks presented a mixed picture, with the Health Care Select Sector SPDR Fund (XLV) slipping approximately 0.7% while biotech ETFs held steady. Investors are awaiting key economic indicators, including Wednesday's January jobs report and Friday's Consumer Price Index data, which could influence market direction and defensive sectors like pharmaceuticals.

Amgen's decline comes despite the company exceeding Wall Street's fourth-quarter expectations last week and providing its 2026 outlook. Commercial operations head Murdo Gordon highlighted the company's experimental obesity drug MariTide as a "paradigm-changing opportunity" with dosing as infrequent as once every three months.

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