On April 30, 2026 Amgen (NASDAQ:AMGN) reported financial results for the first quarter of 2026.
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"Our first quarter results demonstrate the strength of our business, with 16 brands achieving double-digit growth, enabling us to grow through expected patent expirations and increased competition. With a new wave of molecules progressing in Phase 3 clinical development, we’re confident in our ability to deliver attractive long-term growth," said Robert A. Bradway, chairman and chief executive officer.
Key results include:
For the first quarter, total revenues increased 6% to $8.6 billion in comparison to the first quarter of 2025.
Product sales grew 4%, driven by 9% volume growth, partially offset by 2% lower net selling price and 2% from lower inventory levels.
Sixteen products delivered at least double-digit sales growth in the first quarter.
Seventeen products annualizing at more than $1 billion based on first quarter sales.
GAAP earnings per share (EPS) increased 4% from $3.20 to $3.34 for the first quarter, driven by higher operating income, partially offset by net unrealized losses on equity investments in the current-year period compared to net unrealized gains in the prior-year period.
For the first quarter, GAAP operating income increased from $1.2 billion to $2.7 billion, and GAAP operating margin increased 17.4 percentage points to 32.4%.
Non-GAAP EPS increased 5% from $4.90 to $5.15 for the first quarter, driven by higher revenues, partially offset by higher operating expenses.
For the first quarter, non-GAAP operating income increased from $3.6 billion to $3.7 billion, and non-GAAP operating margin decreased 0.4 percentage points to 45.3%.
The Company generated $1.5 billion of free cash flow for the first quarter of 2026 versus $1.0 billion for the first quarter of 2025, driven by business performance and timing of working capital, partially offset by higher capital expenditures.
References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis," and "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion.
Product Sales Performance
General Medicine
Repatha (evolocumab) sales increased 34% year-over-year to $876 million in the first quarter, driven by 35% volume growth and 8% favorable changes to estimated sales deductions, partially offset by 7% lower net selling price.
EVENITY (romosozumab-aqqg) sales increased 27% year-over-year to $562 million in the first quarter, driven by volume growth.
Prolia (denosumab) sales decreased 34% year-over-year to $727 million in the first quarter, primarily driven by 17% lower volume, 10% lower net selling price, and 4% from lower inventory levels. For 2026, we continue to expect accelerated sales erosion driven by increased competition, as multiple biosimilars have launched globally.
Rare Disease
TEPEZZA (teprotumumab-trbw) sales increased 29% year-over-year to $490 million in the first quarter, driven by a 22% impact from higher inventory levels and higher net selling price.
KRYSTEXXA (pegloticase) sales increased 8% year-over-year to $255 million in the first quarter, primarily driven by 20% higher net selling price, partially offset by 8% from lower inventory levels and unfavorable changes to estimated sales deductions.
UPLIZNA (inebilizumab-cdon) sales increased 188% year-over-year to $262 million in the first quarter, primarily driven by volume growth.
TAVNEOS (avacopan) sales increased 32% year-over-year to $119 million in the first quarter, driven by 55% volume growth, partially offset by 15% from lower inventory levels.
Inflammation
TEZSPIRE (tezepelumab-ekko) sales increased 20% year-over-year to $343 million in the first quarter, driven by 32% volume growth, partially offset by 8% from lower inventory levels.
Otezla (apremilast) sales decreased 1% year-over-year to $431 million in the first quarter, as 8% lower net selling price and 2% lower volume were offset by favorable changes to estimated sales deductions.
Enbrel (etanercept) sales decreased 37% year-over-year to $320 million in the first quarter, primarily driven by unfavorable changes to estimated sales deductions of 18% and 15% lower net selling price. The decline in net selling price reflects the impact of U.S. Medicare Part D price setting under the Inflation Reduction Act, effective January 1, 2026, as well as an increased 340B Program mix.
AMJEVITA (adalimumab-atto)/AMGEVITA (adalimumab) sales increased 27% year-over-year to $173 million in the first quarter, primarily driven by 18% higher net selling price and 8% favorable foreign exchange impact.
PAVBLU (aflibercept-ayyh) generated $280 million in the first quarter. Sales increased 9% quarter-over-quarter, driven by 16% volume growth, partially offset by 9% from lower inventory levels.
Oncology
BLINCYTO (blinatumomab) sales increased 12% year-over-year to $415 million in the first quarter, driven by 19% volume growth, partially offset by unfavorable changes to estimated sales deductions.
IMDELLTRA (tarlatamab-dlle)/IMDYLLTRA (tarlatamab) sales increased 219% year-over-year to $258 million in the first quarter, driven by volume growth.
Vectibix (panitumumab) sales increased 7% year-over-year to $287 million in the first quarter, driven by 11% volume growth, partially offset by lower inventory levels.
KYPROLIS (carfilzomib) sales increased 2% year-over-year to $330 million in the first quarter, primarily driven by higher net selling price.
LUMAKRAS/LUMYKRAS (sotorasib) sales increased 11% year-over-year to $94 million in the first quarter, driven by volume growth.
Nplate (romiplostim) sales increased 32% year-over-year to $412 million in the first quarter. Excluding the U.S. government order of $60 million in the first quarter of 2026, Nplate sales increased 12%, driven by 8% volume growth and higher net selling price.
XGEVA (denosumab) sales decreased 27% year-over-year to $411 million in the first quarter, driven by 19% lower volume and lower net selling price. For 2026, we continue to expect accelerated sales erosion driven by increased competition, as multiple biosimilars have launched globally.
MVASI (bevacizumab-awwb) sales decreased 16% year-over-year to $150 million in the first quarter, driven by 8% lower net selling price and 7% unfavorable changes to estimated sales deductions.
Established Products
Our established products, which consist of Aranesp (darbepoetin alfa), Neulasta (pegfilgrastim) and Parsabiv (etelcalcetide), generated $563 million of sales in the first quarter. Sales increased 1% year-over-year, driven by 10% higher net selling price, partially offset by 4% lower volume and 4% unfavorable changes to estimated sales deductions.
Product Sales Detail by Product and Geographic Region
$Millions, except percentages
Q1 ’26
Q1 ’25
YOY Δ
U.S
ROW
TOTAL
TOTAL
TOTAL
Repatha
$ 465
$ 411
$ 876
$ 656
34 %
EVENITY
431
131
562
442
27 %
Prolia
461
266
727
1,099
(34 %)
TEPEZZA
424
66
490
381
29 %
KRYSTEXXA
255
—
255
236
8 %
UPLIZNA
246
16
262
91
*
TAVNEOS
114
5
119
90
32 %
Ultra-Rare products(1)
96
2
98
179
(45 %)
TEZSPIRE
343
—
343
285
20 %
Otezla
352
79
431
437
(1 %)
Enbrel
314
6
320
510
(37 %)
AMJEVITA/AMGEVITA
41
132
173
136
27 %
PAVBLU
276
4
280
99
*
WEZLANA/WEZENLA
4
43
47
150
(69 %)
BLINCYTO
221
194
415
370
12 %
IMDELLTRA/IMDYLLTRA
188
70
258
81
*
Vectibix
136
151
287
267
7 %
KYPROLIS
218
112
330
324
2 %
LUMAKRAS/LUMYKRAS
49
45
94
85
11 %
Nplate
283
129
412
313
32 %
XGEVA
228
183
411
566
(27 %)
MVASI
96
54
150
179
(16 %)
Aranesp
77
234
311
340
(9 %)
Neulasta
149
16
165
129
28 %
Parsabiv
43
44
87
88
(1 %)
Other products(2)
263
52
315
340
(7 %)
Total product sales
$ 5,773
$ 2,445
$ 8,218
$ 7,873
4 %
* Change in excess of 100%
(1) Ultra-Rare products consist of PROCYSBI, RAVICTI, ACTIMMUNE, BUPHENYL and QUINSAIR.
(2) Other products consist of Aimovig, KANJINTI, AVSOLA, BKEMV/BEKEMV, RIABNI, EPOGEN, NEUPOGEN, IMLYGIC, Sensipar/Mimpara, RAYOS, DUEXIS, Corlanor, and PENNSAID. Biosimilars total $185 million in Q1 ’26 and $171 million in Q1 ’25. Rare Disease total ($3) million in Q1 ’26 and ($1) million in Q1 ’25.
Operating Expense, Operating Margin and Tax Rate Analysis
On a GAAP basis:
Total Operating Expenses decreased 15% year-over-year for the first quarter. Cost of Sales as a percentage of product sales decreased 4.3 percentage points, driven by lower amortization expense from acquisition-related assets, partially offset by higher profit share and royalty expense and changes in our sales mix. Research & Development (R&D) expenses increased 16% driven by higher spend in Later-Stage Clinical Programs, including those related to MariTide. Selling, General & Administrative (SG&A) expenses decreased 5% driven by lower general and administrative expenses, partially offset by higher commercial product-related expenses. Other operating income for the first quarter included litigation settlements.
Operating Margin as a percentage of product sales increased 17.4 percentage points to 32.4%.
Tax Rate increased 0.4 percentage points for the first quarter primarily driven by the change in earnings mix, including lower amortization expense from acquisition-related assets, partially offset by the net unrealized losses on our equity investments in the current-year period compared to net unrealized gains in the prior-year period.
On a non-GAAP basis:
Total Operating Expenses increased 8% year-over-year for the first quarter. Cost of Sales as a percentage of product sales increased 1.5 percentage points, driven by higher profit share and royalty expense and changes in our sales mix. R&D expenses increased 16% driven by higher spend in Later-Stage Clinical Programs, including those related to MariTide. SG&A expenses decreased 4% driven by lower general and administrative expenses, partially offset by higher commercial product-related expenses.
Operating Margin as a percentage of product sales decreased 0.4 percentage points for the first quarter to 45.3%.
Tax Rate decreased 1.0 percentage points for the first quarter primarily driven by net favorable items in the current-year period, partially offset by the change in earnings mix.
$Millions, except percentages
GAAP
Non-GAAP
Q1 ’26
Q1 ’25
YOY Δ
Q1 ’26
Q1 ’25
YOY Δ
Cost of Sales
$ 2,744
$ 2,968
(8 %)
$ 1,603
$ 1,420
13 %
% of product sales
33.4 %
37.7 %
(4.3) pts
19.5 %
18.0 %
1.5 pts
Research & Development
$ 1,719
$ 1,486
16 %
$ 1,711
$ 1,475
16 %
% of product sales
20.9 %
18.9 %
2.0 pts
20.8 %
18.7 %
2.1 pts
Selling, General & Administrative
$ 1,602
$ 1,687
(5 %)
$ 1,583
$ 1,655
(4 %)
% of product sales
19.5 %
21.4 %
(1.9) pts
19.3 %
21.0 %
(1.7) pts
Other
$ (113)
$ 830
*
$ —
$ —
N/A
Total Operating Expenses
$ 5,952
$ 6,971
(15 %)
$ 4,897
$ 4,550
8 %
Operating Margin
Operating income as % of product sales
32.4 %
15.0 %
17.4 pts
45.3 %
45.7 %
(0.4) pts
Tax Rate
12.7 %
12.3 %
0.4 pts
13.6 %
14.6 %
(1.0) pts
pts: percentage points
* = Change in excess of 100%
N/A = not applicable
Cash Flow and Balance Sheet
The Company generated $1.5 billion of free cash flow in the first quarter of 2026 versus $1.0 billion in the first quarter of 2025, driven by business performance and timing of working capital, partially offset by higher capital expenditures.
The Company declared a first quarter 2026 dividend on December 9, 2025 of $2.52 per share that was paid on March 6, 2026 to all stockholders of record as of February 13, 2026, representing a 6% increase from the same period in 2025.
During the first quarter of 2026, there were no repurchases of shares of common stock under our stock repurchase program.
Cash and cash equivalents totaled $12.0 billion and debt outstanding totaled $57.3 billion as of March 31, 2026.
$Billions, except shares
Q1 ’26
Q1 ’25
YOY Δ
Operating Cash Flow
$ 2.2
$ 1.4
$ 0.8
Capital Expenditures
$ 0.7
$ 0.4
$ 0.3
Free Cash Flow
$ 1.5
$ 1.0
$ 0.5
Dividends Paid
$ 1.4
$ 1.3
$ 0.1
Share Repurchases
$ 0.0
$ 0.0
$ 0.0
Average Diluted Shares (millions)
544
541
3
Note: Numbers may not add due to rounding
$Billions
3/31/26
12/31/25
YTD Δ
Cash and Cash Equivalents
$ 12.0
$ 9.1
$ 2.9
Debt Outstanding
$ 57.3
$ 54.6
$ 2.7
Note: Numbers may not add due to rounding
2026 Guidance
For the full year 2026, the Company expects:
Total revenues in the range of $37.1 billion to $38.5 billion.
On a GAAP basis, EPS in the range of $15.62 to $17.10, and a tax rate in the range of 14.5% to 16.0%.
On a non-GAAP basis, EPS in the range of $21.70 to $23.10, and a tax rate in the range of 15.0% to 16.5%.
Capital expenditures to be approximately $2.6 billion.
Share repurchases not to exceed $3.0 billion.
First Quarter Product and Pipeline Update
The Company provided the following updates on selected product and pipeline programs:
General Medicine
MariTide (maridebart cafraglutide, AMG 133)
MariTide is a differentiated antibody-peptide conjugate that activates the glucagon-like peptide-1 (GLP-1) receptor and antagonizes the glucose-dependent insulinotropic polypeptide receptor (GIPR) featuring monthly or less frequent dosing.
MARITIME-1, a Phase 3 study of MariTide for chronic weight management, is ongoing in adults living with obesity or overweight, without Type 2 diabetes (T2D).
MARITIME-2, a Phase 3 study of MariTide for chronic weight management, is ongoing in adults living with obesity or overweight, with T2D.
MARITIME-CV, a Phase 3 study of MariTide on cardiovascular (CV) outcomes, is enrolling adults living with established atherosclerotic cardiovascular disease and obesity or overweight.
MARITIME-HF, a Phase 3 study of MariTide on reduction of heart failure events and cardiovascular risk, is enrolling adults living with heart failure with preserved or mildly reduced ejection fraction and obesity.
MARITIME-OSA-1, a Phase 3 study of MariTide, is enrolling adults living with obstructive sleep apnea on positive airway pressure therapy and living with obesity or overweight.
MARITIME-OSA-2, a Phase 3 study of MariTide, is enrolling adults living with obstructive sleep apnea not on positive airway pressure therapy and living with obesity or overweight.
MARITIME-SWITCH, a Phase 3 study of MariTide, was initiated in adults living with obesity or overweight who will be switching from weekly tirzepatide or weekly semaglutide to MariTide on an every eight-week or quarterly dosing schedule.
MARITIME-1 EXTENSION, a Phase 3 long-term extension study of MariTide, was initiated to evaluate the maintenance of weight loss with monthly, every eight-week or quarterly dosing in adults living with obesity or overweight without T2D who completed the MARITIME-1 study.
MARITIME-2 EXTENSION, a Phase 3 long-term extension study of MariTide, was initiated to evaluate the maintenance of weight loss with monthly and every eight-week dosing in adults living with obesity or overweight with T2D who completed the MARITIME-2 study.
Three Phase 3 studies of MariTide in people living with T2D will be initiated in 2026.
A Phase 2b study of MariTide to assess the effect of MariTide on liver fat reduction and weight loss was initiated and is enrolling adults living with obesity or overweight with elevated liver fat.
AMG 513
A Phase 1 study of AMG 513 is enrolling adults living with obesity.
Repatha
In March, results from a new subgroup analysis of the Phase 3 VESALIUS-CV clinical trial were presented at the American College of Cardiology Annual Scientific Session and simultaneously published in the Journal of the American Medical Association. In this subset of 3,655 high-risk patients with diabetes without known significant atherosclerosis, Repatha:
demonstrated a 31% relative reduction in the risk of a composite of coronary heart disease death, heart attack or ischemic stroke (3-P MACE).
demonstrated a 31% reduction in a broader composite that also included ischemia-driven revascularization (4-P MACE).
reduced the risk of heart attack also by 31%.
was associated with a nominal 32% decreased risk of cardiovascular death and a 24% decreased risk of all-cause death.
Further subgroup analysis from VESALIUS-CV in patients who had a prior percutaneous coronary intervention will be presented at the upcoming European Course on Percutaneous Cardiovascular Interventions in May.
Further subgroup analysis from VESALIUS-CV in patients with high-risk of diabetes with and without known atherosclerosis will be presented at the upcoming American Diabetes Association Scientific Sessions in June.
EVOLVE-MI, a Phase 4 study of Repatha initiated within 10 days of an acute myocardial infarction to reduce the risk of cardiovascular events, is ongoing.
Olpasiran (AMG 890)
Olpasiran is a potentially best-in-class small interfering ribonucleic acid (siRNA) molecule that reduces lipoprotein(a) (Lp(a)) synthesis in the liver.
The OCEAN(a)-Outcomes trial, a Phase 3 secondary prevention CV outcomes study, is ongoing in patients with established atherosclerotic CV disease and elevated Lp(a).
The OCEAN(a)-PreEvent trial, a Phase 3 primary prevention CV outcomes study, is enrolling patients with elevated Lp(a) at high risk for a first major CV event.
The OCEAN(a)-Coronary Computed Tomography Angiography (CCTA), a Phase 3 coronary artery plaque study, was initiated and is enrolling patients with atherosclerotic CV disease and elevated Lp(a).
Rare Disease
UPLIZNA
In February, the European Commission approved UPLIZNA as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive.
Phase 3 studies of UPLIZNA in patients with autoimmune hepatitis and in patients with chronic inflammatory demyelinating polyneuropathy will be initiated H2 2026.
TEPEZZA
In April, the Company announced positive topline results from a Phase 3 trial of TEPEZZA administered by subcutaneous injection via an on-body injector (OBI) in adults with moderate-to-severe active Thyroid Eye Disease (TED). In this study, TEPEZZA OBI:
showed comparable efficacy to intravenous (IV) TEPEZZA.
achieved the primary endpoint with a 77% proptosis response rate at week 24 compared to 19.6% for placebo (p<0.0001).
demonstrated a clinically meaningful mean reduction in proptosis of -3.17 mm at week 24 compared to -0.80 mm for placebo (p<0.0001).
showed statistically significant and clinically meaningful improvements across the following additional secondary endpoints: overall responder rate; percentage of patients achieving a Clinical Activity Score (CAS) of 0 or 1; change in diplopia as ordinal response categories; diplopia response rate; complete diplopia responder rate; and mean change from baseline in week 24 in the Graves’ Ophthalmopathy Quality of Life (GO-QoL) appearance subscale.
demonstrated overall safety results that were generally consistent with the known safety profile of TEPEZZA IV. Mild-to-moderate injection site reactions were observed with subcutaneous administration in some patients, which did not result in treatment interruption or discontinuation. The most common adverse events (≥10%) were muscle spasms, tinnitus, weight decrease, ear discomfort, nausea and diarrhea. Full results from the study will be presented at an upcoming medical congress.
A separate Phase 3b/4 trial, conducted to fulfill a U.S. Food and Drug Administration (FDA) postmarketing requirement for TEPEZZA IV, has been completed. The primary objective of the study was to evaluate the safety and tolerability of three treatment durations (four, eight and 16 infusions) of TEPEZZA IV given once every 3 weeks in adult TED patients and assess the need for retreatment. The study was descriptive in nature. The observed risk profile was consistent with the known profile of TEPEZZA IV. The postmarketing data will be submitted to regulatory authorities and presented at an upcoming medical congress.
TAVNEOS
TAVNEOS (avacopan), a product the Company acquired in connection with its acquisition of ChemoCentryx, Inc in 2022, was approved by the FDA in October 2021. TAVNEOS is indicated for the adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) in combination with standard therapy including glucocorticoids.
On April 27, 2026, FDA’s Center for Drug Evaluation and Research (CDER) issued a proposal to withdraw approval of TAVNEOS, asserting that there is new information indicating lack of substantial evidence of effectiveness for the drug and that ChemoCentryx’s application that resulted in FDA approval contained untrue statements of material facts.
On April 30, 2026, the FDA posted a notice in the Federal Register that proposes to withdraw approval of TAVNEOS and announced an opportunity for ChemoCentryx, as the U.S. marketing authorization holder, to request a hearing on this proposal.
As such, ChemoCentryx may request a hearing on this proposal, after which the FDA will determine whether there is a genuine and substantial issue of fact that requires a hearing. If a hearing is not granted, the FDA may enter summary judgment and ultimately withdraw approval.
The Company intends to engage with the FDA, continues to believe that TAVNEOS demonstrates effectiveness and a favorable benefit–risk profile, and intends to follow the appropriate process to support its position. As the FDA’s statement reporting its proposal indicates, TAVNEOS will remain on the market during the pendency of this process.
Hepatotoxicity is a known risk of TAVNEOS treatment for AAV and has been a subject of ongoing dialogue with the FDA. In 2024, the Company provided an analysis of serious post-marketing cases of hepatotoxicity to the FDA. On March 31, 2026, the FDA issued a Drug Safety Communication notifying patients and health care professionals about serious postmarketing cases including fatal cases of drug induced liver injury associated with TAVNEOS.
The current U.S. label includes a warning about hepatotoxicity and guidance for monitoring patients. The Drug Safety Communication provides additional information about drug-induced liver injury and vanishing bile duct syndrome (VBDS) associated with TAVNEOS.
Since approval in 2021, cases of VBDS have been reported, largely from Japan and none from the United States. Most patients who had VBDS were aged 65 years and older, and most cases occurred within 90 days of starting TAVNEOS. VBDS has been fatal in some of these patients. The Company remains committed to keeping patient safety, needs, and support at the forefront.
On April 29, 2026, the Company submitted a Changes Being Effected (CBE-30) supplement to the FDA. The CBE-30 filing amends the hepatotoxicity warning language in the label to provide more information on cases of VBDS that have been observed in the post-marketing setting, including that cases with fatal outcomes have been reported, and modifies language regarding liver panel testing and treatment discontinuation rules.
A Phase 3, open-label study of TAVNEOS in combination with rituximab or a cyclophosphamide-containing regimen is enrolling patients from 6 years to < 18 years of age with active ANCA-associated vasculitis (Granulomatosis with Polyangiitis (GPA)/Microscopic Polyangiitis (MPA)).
Dazodalibep
Dazodalibep is a fusion protein that inhibits CD40L.
Two Phase 3 studies of dazodalibep in Sjögren’s disease are underway. The first study is ongoing in patients with moderate-to-severe systemic disease activity. The second study is ongoing in patients with moderate to high symptom burden with low systemic disease activity. Completion of both studies is expected in H2 2026.
Daxdilimab
Daxdilimab is a first-in-class plasmacytoid dendritic cell (pDC) depleting monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7).
The Company is taking steps to advance daxdilimab to a registrational phase of development.
AMG 329
AMG 329 is a fully human monoclonal antibody targeting FMS-like tyrosine kinase 3 (FLT3) ligand.
A Phase 2 study of AMG 329 in patients with Sjögren’s disease met pre-defined criteria for futility and was stopped.
AMG 732
AMG 732 is an insulin-like growth factor-1 receptor (IGF-1R) targeting monoclonal antibody.
A Phase 2 study of AMG 732 is enrolling patients with moderate-to-severe active TED.
Inflammation
TEZSPIRE
Two Phase 3 studies of TEZSPIRE are enrolling adults with moderate to very severe chronic obstructive pulmonary disease (COPD) and a BEC ≥ 150 cells/µl.
A Phase 3 study of TEZSPIRE is ongoing in patients with eosinophilic esophagitis. Study completion is expected in H2 2026.
Blinatumomab
Blinatumomab is a bispecific T-cell engager (BiTE) molecule targeting CD19.
A Phase 2 study of blinatumomab in autoimmune disease is enrolling adults with refractory rheumatoid arthritis.
A Phase 2 study of blinatumomab in adults with systemic lupus erythematosus (SLE), with and without nephritis, has stopped enrollment. The Company is determining next steps in this setting.
Inebilizumab
Inebilizumab is a B-cell depleting monoclonal antibody targeting CD19.
A Phase 2 study of inebilizumab in autoimmune disease is enrolling adults with SLE with nephritis.
AMG 104 (AZD8630)
AMG 104 is an inhaled anti-thymic stromal lymphopoietin (TSLP) fragment antigen-binding (Fab) protein.
A Phase 2 study is ongoing in patients with asthma. Study completion is expected in H1 2026.
Oncology
BLINCYTO / blinatumomab
Golden Gate, a Phase 3 study of BLINCYTO alternating with low-intensity chemotherapy, is enrolling older adult patients with newly diagnosed CD19-positive Ph-negative B-cell precursor acute lymphoblastic leukemia (B-ALL).
A potentially registration-enabling Phase 2 study of subcutaneous blinatumomab has paused enrollment of both adults and adolescents with relapsed or refractory CD19-positive Philadelphia chromosome (Ph) negative B-ALL.
A Phase 1b/2 study of subcutaneous blinatumomab has paused enrollment of pediatric patients with relapsed / refractory and minimal residual disease positive (MRD+) B-ALL.
IMDELLTRA / tarlatamab
IMDELLTRA is the first and only FDA-approved delta-like ligand 3 (DLL3) targeting BiTE molecule.
In April, China National Medical Products Administration (NMPA) granted a conditional approval to IMDELLTRA for the treatment of third-line extensive stage small cell lung cancer (SCLC).
The Company is advancing a comprehensive, global clinical development program across extensive-stage (ES) and limited-stage (LS) SCLC:
DeLLphi-303, a Phase 1b study of IMDELLTRA in combination with a programmed cell death protein ligand-1 (PD-L1) inhibitor, carboplatin and etoposide or separately in combination with a PD-L1 inhibitor alone, is ongoing in patients with first-line ES-SCLC.
DeLLphi-305, a Phase 3 study of IMDELLTRA and durvalumab is ongoing in first-line ES-SCLC in the maintenance setting.
DeLLphi-306, a Phase 3 study of IMDELLTRA following concurrent chemoradiation therapy, has completed enrollment of patients with LS-SCLC.
DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab, is enrolling patients with second line or later ES-SCLC.
DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens of IMDELLTRA in second-line ES-SCLC has completed enrollment.
DeLLphi-310, a Phase 1b study of IMDELLTRA in combination with YL201, a B7-H3 targeting antibody-drug conjugate, with or without a PD-L1 inhibitor, has paused enrollment of patients with ES-SCLC.
DeLLphi-311, a Phase 1b study of IMDELLTRA in combination with etakafusp alfa (AB248), a novel CD8+ T-cell selective interleukin-2 (IL-2), is enrolling patients with second-line or later ES-SCLC.
DeLLphi-312, a Phase 3 study of IMDELLTRA in combination with carboplatin, etoposide and durvalumab, is enrolling patients with first-line ES-SCLC.
DeLLphi-313, a Phase 1b study of IMDELLTRA in combination with zocilurtatug pelitecan, a DLL3 targeting antibody drug conjugate, with and without a PD-L1 inhibitor was initiated and is enrolling patients with ES-SCLC.
Xaluritamig (AMG 509)
Xaluritamig is a first-in-class bispecific T-cell engager targeting six-transmembrane epithelial antigen of prostate 1 (STEAP1).
XALute, a Phase 3 study of xaluritamig, is enrolling patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with taxane-based chemotherapy.
XALience, a Phase 3 study of xaluritamig in combination with abiraterone is enrolling patients with chemotherapy-naïve mCRPC.
A Phase 1 study of xaluritamig monotherapy and xaluritamig in combination with abiraterone is ongoing in patients with mCRPC who have not yet received taxane-based chemotherapy. This study is also ongoing in patients with mCRPC who have previously received taxane-based chemotherapy in a fully outpatient treatment setting to further improve administration convenience.
A Phase 1b study of neoadjuvant xaluritamig therapy prior to radical prostatectomy is enrolling patients with newly diagnosed localized intermediate or high‐risk prostate cancer.
A Phase 1b study of xaluritamig is ongoing with high-risk biochemically recurrent prostate cancer after definitive therapy.
A Phase 1b study of xaluritamig in combination with androgen receptor pathway inhibitors is enrolling patients with metastatic hormone-sensitive prostate cancer.
A Phase 1b study of xaluritamig was initiated in adults with mCRPC to evaluate an additional dosing regimen.
A Phase 1b study of xaluritamig is enrolling adult, adolescent and pediatric patients with relapsed or refractory Ewing sarcoma.
AMG 193
AMG 193 is a first-in-class small molecule methylthioadenosine (MTA)-cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor.
Following a comprehensive review of the oncology portfolio and emerging AMG 193 clinical data, the Company will discontinue further development of AMG 193.
As such, the following studies will be discontinued:
a Phase 2 study of AMG 193 in patients with methylthioadenosine phosphorylase (MTAP)-null previously treated advanced non-small cell lung cancer (NSCLC).
a Phase 1/1b/2 study of AMG 193 in patients with advanced MTAP-null solid tumors in the dose-expansion portion of the study.
a Phase 1b study of AMG 193 alone or in combination with other therapies in patients with advanced MTAP-null thoracic malignancies.
a Phase 1b study of AMG 193 in combination with other therapies in patients with advanced MTAP-null gastrointestinal, biliary tract or pancreatic cancers.
LUMAKRAS/LUMYKRAS
CodeBreaK 301, a Phase 3 study of LUMAKRAS in combination with Vectibix and FOLFIRI vs. FOLFIRI with or without bevacizumab-awwb, is enrolling patients with first-line KRAS G12C–mutated metastatic colorectal cancer.
CodeBreaK 202, a Phase 3 study of LUMAKRAS plus platinum doublet chemotherapy vs. pembrolizumab plus chemotherapy, is enrolling patients with first-line KRAS G12C–mutated and PD-L1 negative advanced NSCLC.
Nplate
PROCLAIM, a Phase 3 study of Nplate for the treatment of chemotherapy-induced thrombocytopenia, is ongoing in patients with NSCLC, ovarian cancer, or breast cancer.
Biosimilars
A randomized, double-blind comparative clinical study of ABP 206 compared with OPDIVO (nivolumab) is ongoing in patients with treatment-naïve unresectable or metastatic melanoma.
A randomized, double-blind pharmacokinetic similarity study of ABP 234 compared with KEYTRUDA (pembrolizumab) has completed enrollment of patients with early-stage non-squamous NSCLC as adjuvant treatment.
A randomized, double-blind combined pharmacokinetic/comparative clinical study of ABP 234 compared to KEYTRUDA is ongoing in patients with advanced or metastatic non-squamous NSCLC.
A randomized, double-blind, pharmacokinetic similarity/comparative clinical study of ABP 692 compared to OCREVUS (ocrelizumab) is enrolling patients with relapsing-remitting multiple sclerosis.
TEZSPIRE is being developed in collaboration with AstraZeneca.
AMG 104 is being developed in collaboration with AstraZeneca.
Xaluritamig, formerly AMG 509, is being developed pursuant to a research collaboration with Xencor, Inc.
YL201 is an investigational B7-H3 targeting antibody-drug conjugate being developed by MediLink.
Zocilurtatug pelitecan is an investigational DLL-3 targeting antibody-drug conjugate being developed by Zai Lab Limited.
Etakafusp alfa (AB248) is a novel CD8+ T cell selective interleukin-2 (IL-2) being developed by Asher Biotherapeutics.
OPDIVO is a registered trademark of Bristol-Myers Squibb Company.
KEYTRUDA is a registered trademark of Merck & Co., Inc.
OCREVUS is a registered trademark of Genentech, Inc.
(Press release, Amgen, APR 30, 2026, View Source [SID1234664959])