Amgen předložila FDA nové důkazy a žádá o slyšení proti návrhu na stažení léku Tavneos z amerického trhu. Firma uvádí přes 70 studií s více než 2 200 pacienty.
An Amgen sign is seen at the company's headquarters in Thousand Oaks, California, U.S., November 6, 2019. REUTERS/Deena Beasley/File Photo/File Photo Purchase Licensing Rights, opens new tab
CompaniesJuly 24 (Reuters) - Amgen (AMGN.O), opens new tab said on Friday it submitted new evidence to the FDA on July 23 as it seeks a hearing to challenge the proposed withdrawal of its rare-disease drug Tavneos from the U.S. market.
The U.S. Food and Drug Administration in April proposed withdrawing the drug, which treats a rare autoimmune disease that damages blood vessels, citing a lack of proven effectiveness and false statements in its original marketing application.
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Here are some details:
Amgen said it strongly disagrees with the FDA and that its submission includes more than 70 real-world studies involving over 2,200 patients supporting the drug’s effectiveness and safety.
The drug developer said the Duke Clinical Research Institute, which it had commissioned to independently review the pivotal trial, found Tavneos matched a steroid treatment regimen at 26 and 52 weeks, although it did not reproduce the original finding of superiority at 52 weeks.
The FDA did not immediately respond to a Reuters request for comment.
The health regulator in March had separately identified 76 cases of serious liver injury linked to Tavneos, including eight deaths and seven cases of a rare condition that can cause permanent liver damage.
In June, Europe's drug regulator recommended revoking the drug's approval, citing unreliable study data.
Tavneos treats severe active ANCA-associated vasculitis, a rare disease that inflames blood vessels and can damage organs including the kidneys and lungs.
The FDA said in April that Tavneos would remain on the U.S. market unless Amgen removes it or the FDA commissioner orders its withdrawal.
Reporting by Kunal Das in Bengaluru; Editing by Sahal Muhammed
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Pfizer v onkologii těží z akvizice Seagen, když výnosy této divize vzrostly o 9 % na 3,83 miliardy USD. Amgenu naopak škodí pokles starších léků, zejména Prolia a Enbrel.
Pfizer (NYSE: PFE | PFE Price Prediction) and Amgen (NASDAQ: AMGN) both reported Q1 2026 results this quarter, and the numbers reveal two very different bets on the future of oncology. Pfizer is monetizing its Seagen deal today. Amgen is defending a biosimilar cliff while spending to rebuild growth from scratch.
Padcev Carries Pfizer. Biosimilars Bite Amgen. Pfizer’s oncology franchise pulled in $3.83 billion, up 9% year over year, led by Seagen’s crown jewel Padcev at $591 million (+39%) on first-line urothelial share gains. Lorbrena jumped 37%, Orgovyx 43%, and total launched and acquired products grew 22% operationally. That is real commercial momentum.
Amgen’s story is bifurcated. IMDELLTRA soared 219% to $258 million and UPLIZNA jumped 188%, yet legacy supportive care crumbled. Prolia fell 34% to $727 million, XGEVA dropped 27%, and Enbrel slid 37% under Medicare Part D price setting. CEO Robert Bradway framed it optimistically, noting “16 brands achieving double-digit growth, enabling us to grow through expected patent expirations”. The math is tighter than the tone suggests.
Business Driver Pfizer Amgen Oncology engine Seagen ADCs (Padcev, Tukysa) BiTE platform (IMDELLTRA) Biggest drag COVID: Comirnaty -59% Prolia biosimilars -34% Revenue growth +5.4% +5.76% Monetizing Assets vs. Rebuilding a Base Albert Bourla said Pfizer is “off to a strong start in 2026” and singled out oncology and obesity as areas where he expects Pfizer to lead. That confidence rests on existing revenue streams already booking growth. Padcev’s Phase 3 EV-304 trial showed a 47% reduction in tumor recurrence, progression or death in MIBC patients, with a PDUFA target of August 17, 2026.
Amgen’s counter is capital-intensive. MariTide obesity trials, Xaluritamig in prostate cancer, and biosimilars for KEYTRUDA and OPDIVO all require years of spend before payback. Debt sits at $57.3 billion. Amgen is pivoting heavy capital into high-risk, early-stage platforms just to defend its baseline.
The Padcev PDUFA and MariTide Readouts Will Set the Tone I will be watching Padcev’s August 17 PDUFA decision, Elrexfio’s myeloma expansion, and whether Pfizer can hold its reaffirmed $59.5 to $62.5 billion revenue guide against a $1.5 billion generic headwind. For Amgen, MariTide Phase 3 readouts and the pace of Prolia erosion matter most. Any acceleration there pressures the $37.1 to $38.5 billion full-year guide.
Why I Lean Toward Pfizer for Oncology Alpha Personally, I lean Pfizer here. You are paying a forward P/E of 8 for a business collecting cash today from Seagen assets, versus 17 for Amgen’s rebuild story. The 7.07% dividend yield compensates holders during the wait. Amgen’s stock has run 14.1% YTD while Pfizer is flat at -0.07%, which is exactly why I find PFE more interesting now. Investors focused on the growth narrative who can tolerate biosimilar drag will find Amgen’s setup more compelling. If input costs stay volatile and MFN pricing tightens, the cheaper multiple and the working oncology franchise become more attractive on a relative basis.
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Amgen čelí sporům s FDA i s regulátory v Coloradu, ale autor tvrdí, že dopad na byznys i dividendu by byl malý. Ve 1. čtvrtletí tržby vzrostly o 6 % na 8,6 mld. USD a EPS o 4 % na 3,34 USD.
Amgen (AMGN +0.61%) has been grabbing headlines lately, and not always for the right reasons. The company is currently engaged in a battle with the U.S. Food and Drug Administration (FDA), which has demanded that the biotech pull Tavneos, a medicine for severe anti-neutrophil cytoplasmic autoantibody-associated vasculitis (a group of rare autoimmune inflammatory diseases), from the market. The FDA is claiming that Amgen manipulated clinical trial data.
Elsewhere, Amgen has been fighting off attempts by Colorado regulators to cap the annual price of its famous psoriatic arthritis drug, Enbrel. Amgen recently won a court victory in that battle, although it probably isn't completely over yet. With all that going on, some might worry about Amgen's business and ability to maintain its dividend program intact. Should investors seek out other dividend stocks?
Image source: The Motley Fool.
A resilient business Suppose Amgen loses its dispute with the FDA and is forced to take Tavneos out of the U.S. market. Let's also assume that Colorado regulators get their way and put a price cap on Enbrel. What effect would those setbacks have on the company's financial results? The answer is that the immediate impact will be fairly minimal. In the first quarter, Enbrel's revenue was $320 million, down 37% from the year-ago period. The medicine's sales are declining largely due to Medicare price-setting under the Inflation Reduction Act, a 2022 law that gave the U.S. Centers for Medicare & Medicaid Services the authority to negotiate the prices of some of the drugs it spends the most on.
Enbrel was targeted by the first round of negotiations. This means the medicine plays a little role in Amgen's long-term growth plans, especially since it will face biosimilar competition by 2029. Price setting at the state level would accelerate the year-over-year sales decline for the immunosuppressant, but it would do little to fundamentally change Amgen's prospects (although, in fairness, it may set a dangerous legal precedent).
Regarding Amgen having to pull Tavneos from the U.S. market, the medicine was first approved in 2021 and generated $119 million in sales in the first quarter, up 32% year over year. It accounted for just 1.4% of the company's total revenue. This loss also wouldn't be that big a deal. Amgen has proven, time and time again, that it can overcome obstacles of this kind. Last year, it lost patent exclusivity for denosumab, a bone health medicine marketed under brands such as Prolia and Xgeva.
It was a meaningful growth driver, but despite this loss, the company is still performing well. In the first quarter, Amgen's revenue increased 6% year over year to $8.6 billion, while its earnings per share rose 4% to $3.34. Amgen can also overcome the headwinds it is currently facing.
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Amgen's strong pipeline Another reason to be bullish about Amgen's future is the company's pipeline. The biotech is developing several important medicines to bolster its lineup and mitigate the potential negative impact of regulatory and legal setbacks. Perhaps Amgen's most promising candidate is MariTide, an investigational GLP-1 medicine that is being developed across diabetes, weight loss, sleep apnea, cardiovascular outcomes, and more. This drug, which is undergoing several phase 3 studies, could become a leading GLP-1 therapy, especially given its differentiated profile.
MariTide is being developed for once-monthly or less frequent administration. Even with lower weight-loss efficacy than some current options, it could attract many patients and carve out a solid niche in the fast-growing GLP-1 market. And again, it isn't the only exciting pipeline candidate in Amgen's portfolio. Amgen's ability to develop newer, better products to replace older ones whose sales are dropping is another reason the company's outlook is strong.
A strong dividend track record Amgen has a robust underlying business, is posting solid financial results, and boasts a deep pipeline. In addition to all that, the company's dividend track record is pretty impressive. Amgen has increased its payouts every year since it first initiated one in 2011 -- and over the past decade, its dividend has increased by 152%. Meanwhile, the company's forward yield is 2.7%, compared with the S&P 500's average of 1.1%. Amgen may be in the news for the wrong reasons, but the company's dividend remains as safe as ever. Long-term income seekers can still count on this company.
Federální soud zablokoval Coloradu první krok svého druhu, kterým stát stanovil cenový strop na Amgenův Enbrel. Soudce uvedl, že by firmě hrozila významná a nenapravitelná újma.
The Amgen logo is seen in this illustration taken August 3, 2025. REUTERS/Dado Ruvic/Illustration Purchase Licensing Rights, opens new tab
SummaryCompaniesJudge says Amgen likely to face significant, irreparable harmEnbrel price was capped at $31,200 annually, list price tops $100,000Colorado declined to commentJuly 1 (Reuters) - A federal judge on Wednesday blocked Colorado from capping the price of Amgen's (AMGN.O), opens new tab blockbuster arthritis drug Enbrel, a first-of-its-kind move by a U.S. state.
In granting a preliminary injunction, Chief Judge Daniel Domenico of the Denver federal court said Amgen would likely face significant and irreparable harm from charging lower prices, adding that it could affect the drugmaker's negotiations for future contracts with wholesalers and distributors.
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Domenico said that "as a matter of basic economic logic, Amgen is likely to be significantly harmed by a cap on the price of its product, even if the cap applies unevenly" within the supply chain.
He also said that while Colorado had a legitimate interest in helping patients afford Enbrel, and could try doing so through subsidies or negotiations to lower prices as the federal government has done, "capping the price of a patented drug" was not an option.
In October, the Colorado Prescription Drug Affordability Board capped Enbrel prices at $600 for a 50-milligram weekly dose, or $31,200 per year, effective on January 1, 2027.
The list price of Enbrel exceeds $100,000 per year. Amgen had until July 5 to decide whether to continue selling the drug in Colorado.
Genna Morton, a spokeswoman for Colorado's Division of Insurance, said the agency cannot comment on pending litigation. Amgen and its lawyers did not immediately respond to requests for comment.
The U.S. pays about three times as much as other high-income countries for branded drugs, and the federal government and states have pursued policies to keep prices down.
Enbrel, whose chemical name is etanercept, is used to treat arthritis and plaque psoriasis. It is one of Amgen's biggest drugs, accounting for $2.23 billion of sales in 2025.
The Thousand Oaks, California-based drugmaker said Colorado's cap conflicted with federal patent law, violated its due process rights under the U.S. Constitution and threatened patients' access to needed treatment.
Domenico was appointed to the bench by Donald Trump. The U.S. president has nominated Domenico to join the 10th U.S. Circuit Court of Appeals, whose jurisdiction includes Colorado.
Reporting by Jonathan Stempel in New York; Editing by Mark Porter
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The New England Journal of Medicine stáhl článek o klíčové klinické studii podporující schválení Amgenu pro Tavneos poté, co FDA zjistila, že data u devíti pacientů byla změněna a někteří výzkumníci nebyli zaslepeni.
The Amgen logo is seen in this illustration taken August 3, 2025. REUTERS/Dado Ruvic/Illustration Purchase Licensing Rights, opens new tab
CompaniesJune 29 (Reuters) - The New England Journal of Medicine on Monday retracted an article on a pivotal clinical trial that supported approval of Amgen’s (AMGN.O), opens new tab rare-disease drug, citing concerns that patient outcome data were altered and that some researchers had been unblinded.
The journal said two academic authors of the 2021 study requested the retraction, opens new tab after a U.S. Food and Drug Administration investigation found results for nine patients were altered and some researchers were told which patients received the drug, Tavneos, and who did not.
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The changes were not disclosed in the article, said the journal.
An Amgen spokesperson said it "takes scientific integrity seriously and respects the role of journals in upholding the peer review process."
They said results of a "re-adjudication" of the trial's results by the Duke Clinical Research Institute "will be shared with the FDA as part of our hearing submission due by July 29 and submitted for publication. TAVNEOS remains on the market in the U.S."
In April, the FDA's Center for Drug Evaluation and Research (CDER) proposed withdrawing Tavneos' approval, citing a lack of proven effectiveness and false statements in its original application.
In March, the agency identified 76 cases of drug-induced liver injury with evidence suggesting a causal link to Tavneos, including seven cases of vanishing bile duct syndrome (VBDS), a rare condition that can cause permanent liver damage. Eight deaths were reported among those cases.
Tavneos was approved in October 2021 to treat a rare disease called severe active ANCA-associated vasculitis, which inflames small blood vessels and can damage organs like the kidneys and lungs.
Europe's drug regulator last week also recommended revoking the marketing authorization for the drug, citing concerns over the integrity of its trial data.
Amgen has signed up a research firm to independently review the data on Tavneos, as it seeks to prove the drug's benefits before a hearing with the FDA.
Reporting by Puyaan Singh in Bengaluru; Editing by Sahal Muhammed
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EMA doporučila zrušit registraci Amgenu pro lék Tavneos kvůli nedostatečnému přínosu vůči rizikům. Noví pacienti by léčbu neměli zahajovat a stávající mají být převedeni na alternativy.
Item 1 of 2 The logo of Amgen biopharmaceutical company hangs at the Stripe Young Scientist and Technology exhibition at the RDS, in Dublin, Ireland, January 9, 2026. REUTERS/Clodagh Kilcoyne/File Photo
[1/2]The logo of Amgen biopharmaceutical company hangs at the Stripe Young Scientist and Technology exhibition at the RDS, in Dublin, Ireland, January 9, 2026. REUTERS/Clodagh Kilcoyne/File Photo Purchase Licensing Rights, opens new tab
CompaniesJune 26 (Reuters) - The European Medicines Agency on Friday recommended revoking the marketing authorisation for Amgen's (AMGN.O), opens new tab rare autoimmune disease drug, Tavneos, citing a lack of benefits that outweigh its risks.
In April, the U.S. FDA's Center for Drug Evaluation and Research had proposed withdrawing approval of Tavneos, after identifying 76 cases of drug-induced liver injury with evidence suggesting a causal link to the drug.
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The EMA said the clinical study supporting the medicine's EU approval breached good clinical practice principles and the data were found to be incorrect, misleading and no longer reliable for demonstrating Tavneos' effectiveness.
The data collected after the drug was approved, along with additional analyses carried out after the main study, were not enough to prove the medicine's benefits, the EMA said.
Tavneos, approved in 2022 in the EU, treats anti-neutrophil cytoplasmic autoantibody-associated vasculitis, a rare group of autoimmune diseases that cause inflammation in small- to medium-sized blood vessels.
Amgen said in a statement it was "deeply concerned" about the potential impact of the recommendation and that it "continues to believe that Tavneos is an important treatment option for people living with AAV."
The company said CSL Vifor, its partner in Europe, is leading interactions with the EMA regarding the next steps for patients and healthcare providers in Europe.
The EMA's Committee for Medicinal Products for Human Use has recommended that no new patients should start treatment with Tavneos, while existing patients should be switched to suitable alternatives.
Amgen has signed up a research firm to independently review the data on Tavneos, as it seeks to prove the drug's benefits before a hearing with the FDA.
The drugmaker said the deadline for submitting the data to the FDA has been extended to July 29 from June 29.
Reporting by Christy Santhosh in Bengaluru; Editing by Shreya Biswas
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Amgen v 1. čtvrtletí 2026 utržil z biosimilars 835 milionů USD, meziročně o 14 % více. Nové produkty Wezlana a Pavblu pomáhají kompenzovat slabší starší portfolio.
Key Takeaways Amgen's biosimilar portfolio generated $835 million in Q1 2026 sales, up 14% year over year.New launches like Wezlana and Pavblu are helping offset declines in older biosimilar products.AMGN is advancing biosimilars to Opdivo, Keytruda and Ocrevus to tap major biologic markets. Historically known for its innovative biologic medicines such as Enbrel, Prolia and Repatha, Amgen (AMGN - Free Report) has also emerged as one of the global leaders in biosimilars. The company boasts a strong biosimilars portfolio and the business has become an increasingly important contributor to the company's top-line growth strategy. Its biosimilar portfolio spans oncology, inflammation and rare diseases.
Some of Amgen's older biosimilars — Kanjinti (a biosimilar of Roche’s [(RHHBY - Free Report) ] Herceptin), Mvasi (a biosimilar of Roche’s Avastin), Riabni (a biosimilar to Roche’s Rituxan), Avsola (a biosimilar to J&J’s [(JNJ - Free Report) ] Remicade) and Amjevita/Amgevita (a biosimilar of AbbVie’s Humira) — are seeing slowing/declining sales due to rising competitive pressure.
To combat the impact, Amgen has successfully launched biosimilars of J&J’s Stelara, called Wezlana, AstraZeneca’s (AZN - Free Report) Soliris, called Bekemv, and Regeneron’s Eylea, called Pavblu, in the past couple of years.
In the first quarter of 2026, its biosimilar products generated sales of $835 million, up 14% year over year, including $47 million from Wezlana and $280 million from Pavblu. Since the first launch in 2018, Amgen’s biosimilar drugs have delivered more than $14 billion in sales, significantly contributing to top-line growth and generating meaningful cash flows.
Amgen is also developing biosimilars referencing some of the pharmaceutical industry's largest biologics. Phase III studies are ongoing to evaluate biosimilar versions of Bristol-Myers’ Opdivo (ABP 206), Merck’s Keytruda (ABP 234) and Roche’s Ocrevus (ABP 692). These medicines collectively generate tens of billions of dollars in annual sales globally. As patents on these products expire over the next several years, biosimilars targeting them could create substantial revenue opportunities for Amgen.
Over the next few years, Amgen will face a significant patent-expiration overhang. Its own key branded products, such as Prolia, Xgeva, Enbrel and Otezla, have either already lost exclusivity or are expected to do so within the next few years. Together, these medicines accounted for roughly 30% of Amgen’s 2025 product sales, leaving the company exposed to potential revenue pressure from generic and biosimilar competition as patents expire.
Amgen’s new biosimilar launches will play a key role in mitigating the impact of LOE over the next few years, along with Amgen’s key growth drivers, which include Repatha, Evenity, Tezspire and some oncology and rare disease drugs.
While Amgen's biosimilars may not individually achieve blockbuster status comparable to leading innovative therapies, together they represent a meaningful source of recurring revenues, enhance portfolio diversification and provide access to some of the world's largest biologic markets. Over the long term, the biosimilars business is expected to remain a key pillar of Amgen's strategy, supporting a more diversified, resilient and sustainable growth profile.
AMGN’s Price Performance, Valuation and EstimatesAmgen’s stock has risen 5.3% so far this year compared with an increase of 1.3% for the industry.
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From a valuation standpoint, Amgen is reasonably priced. Going by the price/earnings ratio, the company’s shares currently trade at 15.02 forward earnings, which is lower than 17.05 for the industry. The stock is also trading above its five-year mean of 13.81.
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The Zacks Consensus Estimate for earnings has risen from $22.21 per share to $22.26 per share for 2026 over the past 60 days. For 2027, the consensus mark for earnings has risen from $23.35 to $23.70 per share over the same timeframe.
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Amgen has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
