Amgen Faces EU Withdrawal of Tavneos Approval
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 26 2026
0mins
Source: seekingalpha
- Withdrawal Risk: The European Medicines Agency's expert panel has recommended the withdrawal of Amgen's rare disorder therapy Tavneos due to data integrity issues, indicating that the clinical benefits no longer outweigh the risks, which could lead to significant losses for Amgen in the EU market.
- Acquisition Context: Tavneos was acquired by Amgen through its $3.7 billion purchase of ChemoCentryx in 2022, intended for treating two rare inflammatory diseases affecting blood vessels, and this withdrawal could impact Amgen's product portfolio and market competitiveness.
- Clinical Trial Compliance Issues: The EMA highlighted breaches of good clinical practice principles in the Advocate study that supported Tavneos' authorization, exacerbating concerns over the drug's safety and potentially leading to stricter regulatory scrutiny for Amgen.
- U.S. Regulatory Developments: Amgen has informed the FDA that it hired an independent investigator to reevaluate data from the Advocate study, demonstrating the company's proactive approach to regulatory challenges, but it still faces potential market withdrawal and reputational damage.
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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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- Stable Financial Performance: Despite ongoing challenges, Amgen reported a 6% year-over-year revenue increase to $8.6 billion in Q1, demonstrating resilience and the ability to maintain dividend payments amidst adversity.
- Strong R&D Pipeline: Amgen is developing several key drugs, including MariTide, to mitigate the potential negative impacts of regulatory and legal setbacks, thereby enhancing the company's long-term growth prospects.
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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.
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