Amgen Faces EU Withdrawal Risk for Tavneos Amid Market Challenges
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 26 2026
0mins
Source: seekingalpha
Amgen Inc's stock rose by 3.04% and reached a 20-day high amid mixed market conditions, with the Nasdaq-100 down 0.40% while the S&P 500 gained 0.41%.
The European Medicines Agency's expert panel has recommended the withdrawal of Amgen's Tavneos approval due to data integrity issues, indicating that the clinical benefits no longer outweigh the risks. This situation poses a significant risk for Amgen, especially after acquiring Tavneos through its $3.7 billion purchase of ChemoCentryx in 2022. The potential withdrawal could impact Amgen's product portfolio and market competitiveness, despite the company's proactive measures to address regulatory challenges.
This development raises concerns about Amgen's future in the EU market and could lead to reputational damage. Investors will be closely monitoring how the company navigates these challenges and whether it can maintain its competitive edge in the biopharmaceutical sector.
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Analyst Views on AMGN
Wall Street analysts forecast AMGN stock price to fall
24 Analyst Rating
14 Buy
9 Hold
1 Sell
Moderate Buy
Current: 366.440
Low
280.00
Averages
363.10
High
425.00
Current: 366.440
Low
280.00
Averages
363.10
High
425.00
About AMGN
Amgen Inc. is a biotechnology company. It discovers, develops, manufactures and delivers medicines for the toughest diseases. It focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve people’s lives. It operates in the human therapeutics segment. Its marketed products portfolio includes EPOGEN (epoetin alfa); Aranesp (darbepoetin alfa); Parsabiv (etelcalcetide); Neulasta (pegfilgrastim); KANJINTI (trastuzumab-anns); Otezla; BLINCYTO (blinatumomab); ACTIMMUNE (interferon gamma-1b); Neulasta (pegfilgrastim); Sensipar/Mimpara (cinacalcet); Prolia (denosumab); ENBREL; QUINSAIR (levofloxacin); Repatha (evolocumab) and others. It markets ENBREL, a tumor necrosis factor blocker, in the United States and Canada. It markets Otezla, a small molecule that inhibits phosphodiesterase 4, in many countries around the world. It markets Repatha, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in many countries around the world.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Amgen's Growth Potential: Amgen announced a 6% increase in its dividend for 2026 while running late-stage trials for its obesity treatment, which could open substantial market opportunities, attracting income investors with its combination of stable dividends and growth potential.
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- Market Competitive Edge: This study is the only global head-to-head trial comparing KRAS G12C inhibitors, with Divarasib showing superior treatment potential against Amgen's Lumakras and BMY's Krazati, which may enhance Roche's competitive position in the lung cancer market.
- FDA Breakthrough Therapy Designation: Divarasib received Breakthrough Therapy Designation from the FDA in 2022, which is expected to expedite its approval process, addressing the urgent treatment needs of patients with KRAS G12C mutations and filling a significant market gap.
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