FDA Proposes Withdrawal of Tavneos Marketing Authorization
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 hour ago
0mins
Should l Buy AMGN?
Source: seekingalpha
- Safety Concerns Raised: The FDA's proposal to withdraw marketing authorization for Amgen's Tavneos arises from safety issues linked to 76 cases of serious drug-induced liver injury, which could significantly undermine market trust in Amgen's products.
- Data Manipulation Allegations: The FDA revealed that the registrational study for Tavneos was manipulated, misrepresenting its efficacy and violating FDA regulations, which raises serious doubts about the drug's effectiveness and may complicate future drug approval processes.
- Sales Performance Risk: Tavneos generated $423 million in sales for Amgen in 2022, reflecting a 65% year-over-year growth; however, the FDA's proposal could lead to a substantial decline in sales, adversely affecting the company's overall financial performance.
- Market Response Strategy: Amgen has the option to voluntarily withdraw Tavneos before the FDA's decision or request a hearing, with future actions directly impacting its market position and brand reputation in the rare disease sector.
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Analyst Views on AMGN
Wall Street analysts forecast AMGN stock price to rise
24 Analyst Rating
14 Buy
9 Hold
1 Sell
Moderate Buy
Current: 340.180
Low
280.00
Averages
363.10
High
425.00
Current: 340.180
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.
FDA Proposes Withdrawal of Tavneos Marketing Authorization
- Safety Concerns Raised: The FDA's proposal to withdraw marketing authorization for Amgen's Tavneos arises from safety issues linked to 76 cases of serious drug-induced liver injury, which could significantly undermine market trust in Amgen's products.
- Data Manipulation Allegations: The FDA revealed that the registrational study for Tavneos was manipulated, misrepresenting its efficacy and violating FDA regulations, which raises serious doubts about the drug's effectiveness and may complicate future drug approval processes.
- Sales Performance Risk: Tavneos generated $423 million in sales for Amgen in 2022, reflecting a 65% year-over-year growth; however, the FDA's proposal could lead to a substantial decline in sales, adversely affecting the company's overall financial performance.
- Market Response Strategy: Amgen has the option to voluntarily withdraw Tavneos before the FDA's decision or request a hearing, with future actions directly impacting its market position and brand reputation in the rare disease sector.
See More
Analysis of Hedge Fund Holdings in Amgen Inc
- Holding Change Analysis: In the latest 13F filings, 35 hedge funds reported holding shares of Amgen (AMGN), indicating a widespread interest in the stock and suggesting market confidence in its future performance.
- Increase and Decrease Trends: As of March 31, 2026, 15 funds increased their AMGN positions while 13 funds decreased theirs, reflecting market divergence that could impact short-term price volatility.
- Total Holdings Growth: The aggregate AMGN share count held by hedge funds rose from 13,674,492 to 14,582,106 shares, representing an increase of approximately 6.64%, which reflects institutional investors' optimistic outlook on the company.
- Investor Attention Rise: With ongoing interest from hedge funds in AMGN, the market may present more investment opportunities, prompting investors to further explore the stock's potential value.
See More
Pharma Giants Race to Develop Heart Attack Prevention Drugs
- Heart Attack Prevention Drug Development: Novartis, Amgen, and Eli Lilly are conducting late-stage trials to test whether drugs that lower Lp(a) cholesterol levels can effectively prevent heart attacks, with potential annual sales reaching $5.6 billion by 2032 if successful.
- Importance of Clinical Trials: Novartis' pelacarsen has shown over 80% efficacy in reducing Lp(a) levels; however, delays in trial results have raised market concerns about its potential impact, particularly among patients with cardiovascular disease.
- Market Potential and Challenges: Despite the significant market potential for Lp(a) drugs, less than 1% of adults in the U.S. have been tested for Lp(a), and physician reluctance to screen may hinder drug adoption and market acceptance.
- Future Outlook: The results from Novartis' trials will provide direction on the clinical efficacy of Lp(a)-targeting drugs, and if successful, could open a new class of medications to meet the needs of high-risk patients while promoting wider adoption of Lp(a) testing.
See More
Novartis and Others Develop Lp(a) Lowering Drugs
- New Frontier in Heart Disease Prevention: Pharmaceutical giants Novartis, Amgen, and Eli Lilly are conducting late-stage trials to test whether drugs that lower Lp(a) levels can effectively prevent heart attacks, with potential annual sales reaching $5.6 billion by 2032, indicating significant market potential.
- Genetic Determinism: Lp(a) levels are almost entirely genetically determined, with lifestyle factors having limited influence, making drug development crucial for addressing the needs of high Lp(a) patients, particularly as approximately one in five people globally face this issue.
- Importance of Clinical Trials: Novartis's Horizon trial is expected to release results later this year, and if its drug pelacarsen is proven effective in reducing heart attack risk, it will provide critical data support for the entire Lp(a) drug development pipeline, influencing industry confidence.
- Market Acceptance Challenges: Despite rapid drug development, less than 1% of adults in the U.S. were tested for Lp(a) in 2024, reflecting physician hesitance towards screening, indicating that future market acceptance of these drugs will heavily rely on supportive clinical data.
See More
Chaos Erupts at White House Correspondents' Dinner Amid Security Incident
- White House Chaos: An armed man charged a security checkpoint during the White House Correspondents' Dinner, prompting evacuation of President Trump and officials, which has drawn widespread condemnation and highlights increasing political violence in the U.S.
- Investigation Closure: The Justice Department has ended its criminal investigation into Fed Chair Jerome Powell, clearing the way for Trump's nominee Kevin Warsh, which could significantly influence future monetary policy decisions.
- Iran Negotiation Halt: Trump canceled plans to send U.S. representatives to Pakistan for ceasefire talks, resulting in Brent crude prices surpassing $106 per barrel, exerting downward pressure on stock futures amid faltering peace talks.
- Tesla AI Testing: Tesla is beta testing xAI's Grok chatbot for in-vehicle voice commands, aiming to enhance driver experience, but safety experts warn that such features could distract drivers and compromise road safety.
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Trump's White House Dinner Chaos Incident
- White House Dinner Chaos: An armed man charged a security checkpoint during the White House Correspondents' Dinner, prompting the evacuation of Trump and other officials; Trump reported that one officer was shot but saved, highlighting the increasing political violence in the U.S.
- Iran Negotiation Cancellation: Trump canceled plans to send U.S. representatives to Pakistan for ceasefire talks with Iran, stating that Iran could initiate dialogue by calling, which led Brent crude prices to surpass $106 per barrel, exerting downward pressure on stock futures.
- Fed Investigation Closure: The Justice Department ended its criminal investigation into Fed Chair Powell, clearing the way for Trump's nominee Warsh to gain support for confirmation, while Powell now faces a decision on whether to remain as a Fed governor after his term ends.
- Musk vs. Altman Trial: The trial between Musk and OpenAI CEO Altman begins today in Oakland, California, with Musk alleging in a $134 billion lawsuit that OpenAI failed to uphold its promise, which could significantly impact the future business trajectories of both tech leaders.
See More
FDA Proposes Withdrawal of Tavneos Marketing Authorization
- Safety Concerns Raised: The FDA's proposal to withdraw marketing authorization for Amgen's Tavneos arises from safety issues linked to 76 cases of serious drug-induced liver injury, which could significantly undermine market trust in Amgen's products.
- Data Manipulation Allegations: The FDA revealed that the registrational study for Tavneos was manipulated, misrepresenting its efficacy and violating FDA regulations, which raises serious doubts about the drug's effectiveness and may complicate future drug approval processes.
- Sales Performance Risk: Tavneos generated $423 million in sales for Amgen in 2022, reflecting a 65% year-over-year growth; however, the FDA's proposal could lead to a substantial decline in sales, adversely affecting the company's overall financial performance.
- Market Response Strategy: Amgen has the option to voluntarily withdraw Tavneos before the FDA's decision or request a hearing, with future actions directly impacting its market position and brand reputation in the rare disease sector.
See More
Analysis of Hedge Fund Holdings in Amgen Inc
- Holding Change Analysis: In the latest 13F filings, 35 hedge funds reported holding shares of Amgen (AMGN), indicating a widespread interest in the stock and suggesting market confidence in its future performance.
- Increase and Decrease Trends: As of March 31, 2026, 15 funds increased their AMGN positions while 13 funds decreased theirs, reflecting market divergence that could impact short-term price volatility.
- Total Holdings Growth: The aggregate AMGN share count held by hedge funds rose from 13,674,492 to 14,582,106 shares, representing an increase of approximately 6.64%, which reflects institutional investors' optimistic outlook on the company.
- Investor Attention Rise: With ongoing interest from hedge funds in AMGN, the market may present more investment opportunities, prompting investors to further explore the stock's potential value.
See More
Pharma Giants Race to Develop Heart Attack Prevention Drugs
- Heart Attack Prevention Drug Development: Novartis, Amgen, and Eli Lilly are conducting late-stage trials to test whether drugs that lower Lp(a) cholesterol levels can effectively prevent heart attacks, with potential annual sales reaching $5.6 billion by 2032 if successful.
- Importance of Clinical Trials: Novartis' pelacarsen has shown over 80% efficacy in reducing Lp(a) levels; however, delays in trial results have raised market concerns about its potential impact, particularly among patients with cardiovascular disease.
- Market Potential and Challenges: Despite the significant market potential for Lp(a) drugs, less than 1% of adults in the U.S. have been tested for Lp(a), and physician reluctance to screen may hinder drug adoption and market acceptance.
- Future Outlook: The results from Novartis' trials will provide direction on the clinical efficacy of Lp(a)-targeting drugs, and if successful, could open a new class of medications to meet the needs of high-risk patients while promoting wider adoption of Lp(a) testing.
See More
Novartis and Others Develop Lp(a) Lowering Drugs
- New Frontier in Heart Disease Prevention: Pharmaceutical giants Novartis, Amgen, and Eli Lilly are conducting late-stage trials to test whether drugs that lower Lp(a) levels can effectively prevent heart attacks, with potential annual sales reaching $5.6 billion by 2032, indicating significant market potential.
- Genetic Determinism: Lp(a) levels are almost entirely genetically determined, with lifestyle factors having limited influence, making drug development crucial for addressing the needs of high Lp(a) patients, particularly as approximately one in five people globally face this issue.
- Importance of Clinical Trials: Novartis's Horizon trial is expected to release results later this year, and if its drug pelacarsen is proven effective in reducing heart attack risk, it will provide critical data support for the entire Lp(a) drug development pipeline, influencing industry confidence.
- Market Acceptance Challenges: Despite rapid drug development, less than 1% of adults in the U.S. were tested for Lp(a) in 2024, reflecting physician hesitance towards screening, indicating that future market acceptance of these drugs will heavily rely on supportive clinical data.
See More
Chaos Erupts at White House Correspondents' Dinner Amid Security Incident
- White House Chaos: An armed man charged a security checkpoint during the White House Correspondents' Dinner, prompting evacuation of President Trump and officials, which has drawn widespread condemnation and highlights increasing political violence in the U.S.
- Investigation Closure: The Justice Department has ended its criminal investigation into Fed Chair Jerome Powell, clearing the way for Trump's nominee Kevin Warsh, which could significantly influence future monetary policy decisions.
- Iran Negotiation Halt: Trump canceled plans to send U.S. representatives to Pakistan for ceasefire talks, resulting in Brent crude prices surpassing $106 per barrel, exerting downward pressure on stock futures amid faltering peace talks.
- Tesla AI Testing: Tesla is beta testing xAI's Grok chatbot for in-vehicle voice commands, aiming to enhance driver experience, but safety experts warn that such features could distract drivers and compromise road safety.
See More
Trump's White House Dinner Chaos Incident
- White House Dinner Chaos: An armed man charged a security checkpoint during the White House Correspondents' Dinner, prompting the evacuation of Trump and other officials; Trump reported that one officer was shot but saved, highlighting the increasing political violence in the U.S.
- Iran Negotiation Cancellation: Trump canceled plans to send U.S. representatives to Pakistan for ceasefire talks with Iran, stating that Iran could initiate dialogue by calling, which led Brent crude prices to surpass $106 per barrel, exerting downward pressure on stock futures.
- Fed Investigation Closure: The Justice Department ended its criminal investigation into Fed Chair Powell, clearing the way for Trump's nominee Warsh to gain support for confirmation, while Powell now faces a decision on whether to remain as a Fed governor after his term ends.
- Musk vs. Altman Trial: The trial between Musk and OpenAI CEO Altman begins today in Oakland, California, with Musk alleging in a $134 billion lawsuit that OpenAI failed to uphold its promise, which could significantly impact the future business trajectories of both tech leaders.
See More
