AMGEN Inc NASDAQ:AMGN Price, Chart, News & Insight

NASDAQ:AMGN

Amgen Slips 0.8% Premarket as Strong Q3 Growth Is Offset by Biosimilar Pressure and Lower Cash Flow

Amgen (NASDAQ: AMGN) shares fell about 0.8% in premarket trading despite reporting strong third-quarter 2026 revenue and earnings growth, as weakness in several mature products and lower free cash flow offset broad portfolio strength.

Third-quarter revenue increased 8% year over year to $10.4 billion, driven by higher product volumes. GAAP EPS rose 19% to $7.08, while non-GAAP EPS increased 14% to $6.45. GAAP operating margin expanded sharply to 37.5%, while non-GAAP operating margin improved slightly to 47.3%.

Several growth products delivered strong gains. Repatha sales increased 37% to $1.09 billion, EVENITY rose 39% to $751 million and TEZSPIRE climbed 43% to $538 million. UPLIZNA revenue surged 191% to $451 million, while IMDELLTRA increased 128% to $406 million.

However, biosimilar competition continued to weigh heavily on established products. Prolia sales fell 45% to $632 million and XGEVA declined 47% to $288 million following multiple biosimilar launches. Otezla sales also dropped 18%, while TEPEZZA declined 6%.

Free cash flow decreased to $3.7 billion from $4.2 billion a year earlier, mainly because of working-capital changes and a favorable timing benefit in the prior-year period.

The modest 0.8% premarket decline appears to reflect the mixed composition of the quarter rather than weakness in overall earnings. Amgen continues to generate strong growth across newer cardiovascular, rare disease and oncology products, but accelerating biosimilar erosion in Prolia and XGEVA, along with softer cash flow, remains an important offset to the company’s broader commercial momentum.

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European Investor 11-04-26

Amgen Stock Jumps 4% After Positive Phase 3 Dazodalibep Results in Sjögren’s Disease

Amgen shares rose 4% to $408.88 after the company reported positive topline results from the Phase 3 OASIZ 301 study of dazodalibep in adults with moderate-to-severe systemic Sjögren’s disease.

The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in systemic disease activity at Week 48, measured by the ESSDAI score. Amgen said improvement was visible as early as Week 4 and was sustained through Week 48.

The result is notable because there are currently no FDA-approved medicines specifically for Sjögren’s disease, creating a potentially significant commercial opportunity if dazodalibep ultimately reaches the market. The drug is designed as a CD40L antagonist fusion protein that disrupts immune-cell interactions involved in disease activity.

Safety findings were broadly manageable, with the most common adverse events including nasopharyngitis, urinary tract infection, hypertension and infusion-related reactions. Amgen said treatment discontinuations due to adverse events were low and balanced across study groups.

The company plans to present detailed OASIZ 301 data at an upcoming medical meeting, while the separate Phase 3 OASIZ 303 study is expected to complete in the fourth quarter of 2026.

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Global Finance News 09-22-26

FDA Approves Shorter Monitoring Period for Amgen’s IMDELLTRA Lung Cancer Treatment

Amgen said the U.S. Food and Drug Administration approved an update to the prescribing information for IMDELLTRA, significantly reducing the recommended monitoring period following the first two doses of the company’s small cell lung cancer therapy.

Under the updated label, patients should be monitored for six to eight hours from the start of their first two infusions, down from the previous recommendation of 22 to 24 hours. Patients will receive a follow-up assessment, including vital signs, the day after each of those doses.

The change could make IMDELLTRA easier to administer outside major treatment centers. Amgen noted that an estimated 80% to 85% of U.S. cancer patients receive care in community oncology settings, where lengthy monitoring requirements can complicate treatment.

IMDELLTRA is a first-in-class targeted immunotherapy designed to bind DLL3 on tumor cells and CD3 on T cells, activating the immune system against DLL3-expressing small cell lung cancer cells. It is approved for adults with extensive-stage small cell lung cancer whose disease has progressed during or after platinum-based chemotherapy.

The FDA decision follows Amgen’s recent announcement of positive overall-survival results from the Phase 3 DeLLphi-305 study evaluating IMDELLTRA with Imfinzi in first-line extensive-stage small cell lung cancer.

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WS Investor 09-14-26

Amgen’s IMDELLTRA Combination Delivers Overall Survival Win in Phase 3 Lung Cancer Trial

Amgen (NASDAQ: AMGN) announced positive Phase 3 results for IMDELLTRA in extensive-stage small cell lung cancer, reporting a statistically significant and clinically meaningful improvement in overall survival when the drug was combined with AstraZeneca’s Imfinzi.

The Phase 3 DeLLphi-305 trial evaluated IMDELLTRA plus Imfinzi as first-line maintenance therapy against Imfinzi alone in patients whose disease had not progressed following initial treatment with Imfinzi, platinum-based chemotherapy and etoposide.

The study met its primary overall survival endpoint at a pre-specified interim analysis. It also achieved statistically significant and clinically meaningful improvements in progression-free survival and objective response rate.

Importantly, Amgen said the combination’s safety profile was consistent with the known profiles of the individual drugs, with no new or unexpected safety signals identified.

The 563-patient trial represents the first Phase 3 study involving a Bispecific T-cell Engager therapy to demonstrate an overall survival benefit in the first-line maintenance setting for extensive-stage small cell lung cancer.

The results could significantly expand the commercial opportunity for IMDELLTRA, which is already FDA-approved for adults with extensive-stage small cell lung cancer whose disease progressed on or after platinum-based chemotherapy. Success in DeLLphi-305 potentially moves the therapy into an earlier and considerably broader treatment setting.

Amgen plans to present detailed results at an upcoming international medical congress and submit the data to regulatory authorities.

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The Investor 09-08-26

Amgen Stock Plunges 9.7% as BMO Capital Downgrades Shares

Amgen (NASDAQ: AMGN) shares fell 9.7% Tuesday as the biotechnology company faced a more cautious analyst outlook, including a downgrade from BMO Capital Markets.

BMO Capital downgraded Amgen from Outperform to Market Perform while setting a $450 price target. With Amgen trading around $394.79, the target still implies approximately 14% upside from the current share price.

Separately, Cantor Fitzgerald reiterated its Neutral rating on Amgen with a $400 price target. That target is only slightly above the current share price, suggesting limited upside under Cantor’s assessment.

The combination of BMO’s downgrade and Cantor’s continued Neutral stance adds to cautious sentiment surrounding Amgen following the stock’s sharp decline.

Despite BMO’s $450 target remaining above the current market price, the move from Outperform to Market Perform represents a meaningful reduction in its conviction. With shares down nearly 10% in the session, investors will be watching for developments that could explain the sharp selloff and determine whether the decline creates a more attractive valuation or signals increased risks for the biotechnology company.

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The Investor 09-08-26

Amgen’s Repatha Cuts Risk of Death by 20% in High-Risk Patients

Amgen (NASDAQ: AMGN) announced Monday that its cholesterol-lowering drug Repatha reduced the risk of death by 20% among high-risk adults who had not previously suffered a heart attack or stroke, according to a pre-specified analysis of the Phase 3 VESALIUS-CV trial.

The study included more than 12,000 patients and evaluated Repatha alongside statins or other LDL cholesterol-lowering treatments. Amgen said the drug produced meaningful reductions in both all-cause and cardiovascular mortality, with the mortality benefit beginning to emerge after approximately 1.5 years and continuing through a median follow-up of 4.6 years.

The findings make Repatha the first PCSK9 inhibitor to demonstrate a reduction in all-cause mortality in a Phase 3 trial involving high-risk primary-prevention patients, according to Amgen. The results were presented at the European Society of Cardiology Congress 2026 and simultaneously published in Circulation.

Additional analyses strengthened the cardiovascular case for Repatha. The treatment reduced first, subsequent and total cardiovascular events, while a reduction in heart-attack risk was observed as early as six months after treatment began. The benefit was primarily associated with fewer heart attacks caused by atherosclerotic plaque rupture and fewer larger infarctions.

The results could strengthen Repatha’s position in the cardiovascular market by supporting earlier and more aggressive LDL reduction before patients experience their first major cardiovascular event. Amgen also presented real-world studies showing that many high-risk patients remain undertreated and fail to reach recommended LDL cholesterol targets, suggesting a potentially significant population that could benefit from more intensive lipid-lowering therapy.

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The Investor 08-31-26

Amgen and AstraZeneca Report Positive Phase 3 TEZSPIRE Results in Eosinophilic Esophagitis

Amgen (NASDAQ: AMGN) and AstraZeneca reported positive Phase 3 results for TEZSPIRE in patients with eosinophilic esophagitis (EoE), potentially opening another major indication for the drug.

In the CROSSING trial, TEZSPIRE achieved statistically significant and clinically meaningful improvements across both co-primary endpoints — histologic remission and the frequency and severity of difficulty swallowing — at Week 24. The benefits were sustained through Week 52, while the safety profile remained generally consistent with TEZSPIRE’s currently approved indications.

The Phase 3 trial enrolled 368 adults and adolescents with symptomatic, active EoE and compared two TEZSPIRE doses with placebo. Full results will be presented at an upcoming medical meeting and submitted to regulatory authorities.

The results are strategically important because EoE would represent a third epithelial-driven inflammatory disease in which TEZSPIRE has demonstrated efficacy. The drug is already approved for severe asthma and inadequately controlled chronic rhinosinusitis with nasal polyps in several major markets.

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Global Finance News 08-27-26

Amgen Stock Rises 2.7% as Argus Raises Price Target and Morgan Stanley Reiterates Overweight

Amgen (NASDAQ: AMGN) shares are up about 2.7% following positive analyst actions from Argus and Morgan Stanley, adding to bullish sentiment around the biotechnology company.

Argus analyst Jasper Hellweg raised the firm's price target on Amgen to $460 from $375 while maintaining a Buy rating. The new target represents roughly 5% upside from the stock's current price of $436.60.

Morgan Stanley analyst Terence Flynn also reiterated an Overweight rating on Amgen. Although the displayed $362 price target is below the current share price, the continued Overweight recommendation provides another positive signal on the company's broader outlook.

Amgen is one of the world's largest biotechnology companies, with a diversified portfolio spanning oncology, cardiovascular disease, inflammation and rare diseases. Its scale, established product portfolio and pipeline provide a relatively defensive position within the biotech sector, while newer products and pipeline development offer additional growth opportunities.

The 2.7% gain appears supported by the combination of Argus' substantial price-target increase and Morgan Stanley's reiterated bullish rating, with Argus' move particularly notable given the increase from $375 to $460.

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Global Finance News 08-19-26

Amgen Stock Edges Higher After Strong Q2 Earnings as Growth Portfolio Drives Double-Digit Revenue Increase

Amgen (NASDAQ: AMGN) shares rose about 1% in after-hours trading on Tuesday after the biotechnology company reported stronger second-quarter results, supported by broad-based product growth, expanding profitability, and solid cash generation.

Second-quarter revenue increased 10% year over year to $10.1 billion, while product sales climbed 9% on higher volumes. GAAP earnings per share surged 65% to $4.37, and non-GAAP EPS increased 4% to $6.29, exceeding the prior year's performance despite higher research and operating expenses. The company also generated $3.5 billion in free cash flow during the quarter, nearly doubling from a year earlier.

Growth was driven by Amgen's expanding portfolio, with six key growth products collectively rising 26% year over year and accounting for nearly 70% of total product sales. Twenty-two products delivered double-digit sales growth, while seventeen products are now generating annualized sales exceeding $1 billion.

Several blockbuster medicines posted particularly strong results. Repatha sales jumped 37%, EVENITY climbed 38%, TEZSPIRE gained 42%, and rare disease therapies continued to perform well, led by UPLIZNA, whose sales surged 90%. Oncology products also remained a key growth driver, with IMDELLTRA sales more than doubling, while BLINCYTO, Nplate, Vectibix and LUMAKRAS all delivered double-digit growth.

Not every product performed as strongly. Sales of Prolia and XGEVA declined sharply as biosimilar competition intensified, while Otezla, Enbrel and Kyprolis also posted lower sales.

Looking ahead, Amgen reaffirmed its full-year 2026 outlook, expecting revenue between $38.2 billion and $39.4 billion and non-GAAP earnings per share of $22.30 to $23.50. The company also continues advancing its late-stage pipeline, including obesity candidate MariTide and several Phase 3 programs, while expanding existing medicines into new indications.

Investors appeared encouraged by the combination of double-digit revenue growth, continued strength across Amgen's newer products, improving cash generation, and management's confidence in sustaining long-term growth despite increasing biosimilar competition across parts of its mature portfolio.

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WS Investor 08-04-26

Amgen (NASDAQ:AMGN) will report its first quarter 2026 financial results on Thursday, April 30, 2026, after the close of the U.S. markets.

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The Investor 04-26-26

09-08-26The Investor

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