On November 4, 2025 Amgen (NASDAQ:AMGN) reported financial results for the third quarter of 2025.
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"We delivered strong volume growth this quarter, reflecting the demand for our medicines and the impact we’re having on patients worldwide. With disciplined investment and a pipeline of first-in-class medicines, we’re focused on expanding access, advancing innovation, and sustaining long-term growth," said Robert A. Bradway, chairman and chief executive officer.
Key results include:
•For the third quarter, total revenues increased 12% to $9.6 billion in comparison to the third quarter of 2024.
◦Product sales grew 12%, driven by 14% volume growth, partially offset by 4% lower net selling price.
◦Sixteen products delivered at least double-digit sales growth in the third quarter, including Repatha (evolocumab), EVENITY (romosozumab-aqqg), IMDELLTRA (tarlatamab-dlle)/IMDYLLTRA (tarlatamab), TEZSPIRE (tezepelumab-ekko), TEPEZZA (teprotumumab-trbw), BLINCYTO (blinatumomab), UPLIZNA (inebilizumab-cdon), and TAVNEOS (avacopan).
•GAAP earnings per share (EPS) increased 14% from $5.22 to $5.93, driven by higher revenues, partially offset by higher operating expenses, including an Otezla intangible asset impairment charge of $400 million recorded during the third quarter of 2025.
◦GAAP operating income increased from $2.0 billion to $2.5 billion, and GAAP operating margin increased 2.5 percentage points to 27.6%.
•Non-GAAP EPS increased 1% from $5.58 to $5.64, primarily driven by higher revenues, partially offset by higher operating expenses and a higher effective tax rate.
◦Non-GAAP operating income increased from $4.0 billion to $4.3 billion, and non-GAAP operating margin decreased 2.5 percentage points to 47.1%.
•The Company generated $4.2 billion of free cash flow in the third quarter of 2025 versus $3.3 billion in the third quarter of 2024, driven by the timing of working capital items and lower interest payments, partially offset by higher capital expenditures.
Product Sales Performance
General Medicine
•Repatha (evolocumab) sales increased 40% year-over-year to $794 million in the third quarter primarily driven by volume growth.
•EVENITY (romosozumab-aqqg) sales increased 36% year-over-year to $541 million in the third quarter, driven by volume growth.
•Prolia (denosumab) sales increased 9% year-over-year to $1.1 billion in the third quarter, primarily driven by 14% favorable changes to estimated sales deductions, partially offset by lower net selling price. For the remainder of 2025, we expect sales erosion driven by biosimilar competition, as biosimilars have launched in the U.S. market.
Rare Disease
•TEPEZZA (teprotumumab-trbw) sales increased 15% year-over-year to $560 million in the third quarter, driven by higher inventory levels and higher net selling price.
•KRYSTEXXA (pegloticase) sales increased 3% year-over-year to $320 million in the third quarter, driven by 9% volume growth and 3% higher net selling price, partially offset by 10% lower inventory levels.
•UPLIZNA (inebilizumab-cdon) sales increased 46% year-over-year to $155 million in the third quarter, primarily driven by volume growth. Year-over-year sales were impacted by the timing of shipments to our ex-U.S. partner, as shipments similar to those that occurred in the third quarter of 2024 occurred in the second quarter of 2025. Excluding these shipments, sales grew by 101% year-over-year in the third quarter.
•TAVNEOS (avacopan) sales increased 34% year-over-year to $107 million in the third quarter, driven by 66% volume growth, partially offset by 16% lower inventory levels and 10% lower net selling price.
•Ultra-Rare products, which consist of RAVICTI (glycerol phenylbutyrate), PROCYSBI (cysteamine bitartrate), ACTIMMUNE (interferon gamma-1b), BUPHENYL (sodium phenylbutyrate), and QUINSAIR (levofloxacin) generated $200 million of sales in the third quarter. Sales increased 6% year-over-year for the third quarter, primarily driven by higher inventory levels.
Inflammation
•TEZSPIRE (tezepelumab-ekko) sales increased 40% year-over-year to $377 million in the third quarter, driven by 48% volume growth, partially offset by lower net selling price.
•Otezla (apremilast) sales increased 4% year-over-year to $585 million in the third quarter, primarily driven by 6% volume growth and 5% favorable changes to estimated sales deductions, partially offset by 5% lower net selling price.
•Enbrel (etanercept) sales decreased 30% year-over-year to $580 million in the third quarter, primarily driven by 38% lower net selling price resulting from the impact of the U.S.
Medicare Part D redesign and increased 340B Program mix, partially offset by favorable changes to estimated sales deductions and volume growth.
•AMJEVITA (adalimumab-atto)/AMGEVITA (adalimumab) sales decreased 7% year-over-year to $154 million in the third quarter, driven by unfavorable changes to estimated sales deductions.
•PAVBLU (aflibercept-ayyh) generated $213 million of sales in the third quarter.
•WEZLANA (ustekinumab-auub)/WEZENLA (ustekinumab) generated $44 million of sales in the third quarter.
Oncology
•BLINCYTO (blinatumomab) sales increased 20% year-over-year to $392 million in the third quarter, driven by 31% volume growth, partially offset by lower inventory levels.
•Vectibix (panitumumab) sales increased 1% year-over-year to $284 million in the third quarter.
•KYPROLIS (carfilzomib) sales decreased 5% year-over-year to $359 million in the third quarter, driven by lower volume.
•LUMAKRAS/LUMYKRAS (sotorasib) sales decreased 2% year-over-year to $96 million in the third quarter.
•XGEVA (denosumab) sales were flat year-over-year at $539 million in the third quarter, as 6% favorable changes to estimated sales deductions were offset by 3% lower volume and lower inventory levels. For the remainder of 2025, we expect sales erosion driven by biosimilar competition, as biosimilars have launched in the U.S. market.
•Nplate (romiplostim) sales were flat year-over-year at $457 million in the third quarter. U.S. government orders were $90 million in Q3’25 compared to $128 million in Q3’24. Excluding these U.S. government orders, Nplate sales increased 12% year-over-year, driven by volume growth.
•IMDELLTRA (tarlatamab-dlle)/IMDYLLTRA (tarlatamab) generated $178 million of sales in the third quarter. Sales increased 33% quarter-over-quarter, primarily driven by volume growth.
•MVASI (bevacizumab-awwb) sales increased 9% year-over-year to $213 million in the third quarter, driven by favorable changes to estimated sales deductions.
Established Products
•Our established products, which consist of Aranesp (darbepoetin alfa), Parsabiv (etelcalcetide), and Neulasta (pegfilgrastim), generated $533 million of sales in the third quarter. Sales increased 3% year-over-year for the third quarter, driven by 9% favorable changes to estimated sales deductions and 5% volume growth, partially offset by lower net selling price.
Product Sales Detail by Product and Geographic Region
$Millions, except percentages Q3 ’25 Q3 ’24 YOY Δ
U.S.
ROW TOTAL TOTAL TOTAL
Repatha
$ 442 $ 352 $ 794 $ 567 40%
EVENITY
417 124 541 399 36%
Prolia
806 333 1,139 1,045 9%
TEPEZZA
518 42 560 488 15%
KRYSTEXXA
320 — 320 310 3%
UPLIZNA
146 9 155 106 46%
TAVNEOS
101 6 107 80 34%
Ultra-Rare products(1)
195 5 200 188 6%
TEZSPIRE
377 — 377 269 40%
Otezla
473 112 585 564 4%
Enbrel
574 6 580 825 (30%)
AMJEVITA/AMGEVITA
16 138 154 166 (7%)
PAVBLU
212 1 213 — N/A
WEZLANA/WEZENLA
— 44 44 5 *
BLINCYTO
236 156 392 327 20%
Vectibix
162 122 284 282 1%
KYPROLIS
225 134 359 378 (5%)
LUMAKRAS/LUMYKRAS
57 39 96 98 (2%)
XGEVA
357 182 539 541 0%
Nplate
333 124 457 456 0%
IMDELLTRA/IMDYLLTRA
144 34 178 36 *
MVASI
156 57 213 195 9%
Aranesp
103 254 357 337 6%
Parsabiv
42 42 84 70 20%
Neulasta
72 20 92 110 (16%)
Other products(2)
267 50 317 309 3%
Total product sales $ 6,751 $ 2,386 $ 9,137 $ 8,151 12%
N/A = not applicable
* Change in excess of 100%
(1) Ultra-Rare products consist of RAVICTI, PROCYSBI, ACTIMMUNE, BUPHENYL and QUINSAIR .
(2) Other products consist of Aimovig, AVSOLA, KANJINTI, EPOGEN, RIABNI, BKEMV/BEKEMV, NEUPOGEN, IMLYGIC, Corlanor, DUEXIS, RAYOS, Sensipar/Mimpara and PENNSAID, where Biosimilars total $151 million in Q3 ’25 and $143 million in Q3 ’24.
Operating Expense, Operating Margin and Tax Rate Analysis
On a GAAP basis:
•Total Operating Expenses increased 9% year-over-year for the third quarter. Cost of Sales as a percentage of product sales decreased 6.9 percentage points driven by lower amortization expense from the fair value step-up of inventory acquired from Horizon and lower manufacturing costs, partially offset by higher profit share expense and changes in our sales mix. Research & Development (R&D) expenses increased 31% driven by higher spend in later-stage clinical programs, including those related to MariTide, for which six global Phase 3 studies are underway. Selling, General & Administrative (SG&A) expenses increased 6% driven by higher general and administrative expenses, partially offset by lower Horizon acquisition-related expenses. Other operating expenses included the Otezla intangible asset impairment charge of $400 million.
•Operating Margin as a percentage of product sales increased 2.5 percentage points in the third quarter to 27.6%.
•Tax Rate increased 9.3 percentage points in the third quarter due to the change in earnings mix, including lower amortization expense from the fair value step-up of inventory acquired from Horizon.
On a non-GAAP basis:
•Total Operating Expenses increased 18% year-over-year for the third quarter. Cost of Sales as a percentage of product sales increased 0.4 percentage points driven by higher profit share expense and changes in our sales mix, partially offset by lower manufacturing costs. R&D expenses increased 31% driven by higher spend in later-stage clinical programs, including those related to MariTide, for which six global Phase 3 studies are underway. SG&A expenses increased 9% driven by higher general and administrative expenses.
•Operating Margin as a percentage of product sales decreased 2.5 percentage points in the third quarter to 47.1%.
•Tax Rate increased 4.8 percentage points in the third quarter due to the change in earnings mix.
$Millions, except percentages GAAP Non-GAAP
Q3 ’25 Q3 ’24 YOY Δ Q3 ’25 Q3 ’24 YOY Δ
Cost of Sales $ 3,082 $ 3,310 (7%) $ 1,662 $ 1,454 14%
% of product sales 33.7 % 40.6 % (6.9) pts. 18.2 % 17.8 % 0.4 pts.
Research & Development $ 1,900 $ 1,450 31% $ 1,890 $ 1,440 31%
% of product sales 20.8 % 17.8 % 3.0 pts. 20.7 % 17.7 % 3.0 pts.
Selling, General & Administrative $ 1,720 $ 1,625 6% $ 1,700 $ 1,565 9%
% of product sales 18.8 % 19.9 % (1.1) pts. 18.6 % 19.2 % (0.6) pts.
Other $ 329 $ 71 * $ — $ — N/A
Total Operating Expenses $ 7,031 $ 6,456 9% $ 5,252 $ 4,459 18%
Operating Margin
Operating income as % of product sales
27.6 % 25.1 % 2.5 pts. 47.1 % 49.6 % (2.5) pts.
Tax Rate 18.0 % 8.7 % 9.3 pts. 18.2 % 13.4 % 4.8 pts.
pts: percentage points
* = Change in excess of 100%
N/A = not applicable
Cash Flow and Balance Sheet
•The Company generated $4.2 billion of free cash flow in the third quarter of 2025 versus $3.3 billion in the third quarter of 2024, driven by the timing of working capital items and lower interest payments, partially offset by higher capital expenditures.
•The Company declared a third quarter 2025 dividend on August 1, 2025 of $2.38 per share that was paid on September 12, 2025 to all stockholders of record as of August 22, 2025, representing a 6% increase from the same period in 2024.
•The Company retired $1.6 billion of debt during the third quarter of 2025 and $6.0 billion year to date.
•During the third quarter of 2025, there were no repurchases of shares of common stock under our stock repurchase program.
•Cash and cash equivalents totaled $9.4 billion and debt outstanding totaled $54.6 billion as of September 30, 2025.
$Billions, except shares Q3 ’25 Q3 ’24 YOY Δ
Operating Cash Flow $ 4.7 $ 3.6 $ 1.1
Capital Expenditures $ 0.4 $ 0.3 $ 0.2
Free Cash Flow $ 4.2 $ 3.3 $ 0.9
Dividends Paid $ 1.3 $ 1.2 $ 0.1
Share Repurchases $ 0.0 $ 0.0 $ 0.0
Average Diluted Shares (millions) 542 542 0
Note: Numbers may not add due to rounding
$Billions 9/30/25 12/31/24 YTD Δ
Cash and Cash Equivalents $ 9.4 $ 12.0 $ (2.5)
Debt Outstanding $ 54.6 $ 60.1 $ (5.5)
Note: Numbers may not add due to rounding
2025 Guidance
For the full year 2025, the Company expects:
•Total revenues in the range of $35.8 billion to $36.6 billion.
•On a GAAP basis, EPS in the range of $13.76 to $14.60, and a tax rate in the range of 14.5% to 16.0%.
•On a non-GAAP basis, EPS in the range of $20.60 to $21.40, and a tax rate in the range of 15.0% to 16.5%.
•Capital expenditures in the range of $2.2 billion to $2.3 billion.
•Share repurchases not to exceed $500 million.
This guidance includes the estimated impact of implemented tariffs, but does not account for any tariffs or potential pricing actions announced or described but not implemented as well as any tariffs, sector specific tariffs, or pricing actions that could be implemented in the future.
Third 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).
•MARITIME-1, a Phase 3 study of MariTide for chronic weight management, has completed enrollment of adults living with obesity or overweight, without Type 2 Diabetes (T2D).
•MARITIME-2, a Phase 3 study of MariTide for chronic weight management, has completed enrollment of 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, was recently initiated in 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, was recently initiated in adults living with obstructive sleep apnea not on positive airway pressure therapy and living with obesity or overweight.
•Part 2 of the Phase 2 chronic weight management study is ongoing in adults living with obesity or overweight, with or without T2D. Data readout is anticipated in Q4 2025.
•A Phase 2 study investigating MariTide for the treatment of T2D is ongoing in adults living with and without obesity. Data readout is anticipated in Q4 2025.
AMG 513
•A Phase 1 study of AMG 513 is enrolling adults living with obesity.
Repatha
•In October, the Company announced that the Phase 3 VESALIUS-CV clinical trial met its dual primary endpoints demonstrating that Repatha significantly reduced the risk of major adverse CV events (MACE) in individuals without a prior history of heart attack or stroke.
◦The landmark Phase 3 VESALIUS-CV trial enrolled over 12,000 high-risk patients, approximately 85% of whom were maintained on a high or moderate intensity low-density lipoprotein cholesterol (LDL-C) reducing therapy. Patients were followed for a median of approximately 4.5 years.
◦The VESALIUS-CV primary endpoints were time to first occurrence of a composite of coronary heart disease (CHD) death, heart attack or ischemic stroke as well as time to first occurrence of a composite of CHD death, heart attack, ischemic stroke or any ischemia-driven arterial revascularization. The results show that the primary endpoints were both statistically and clinically significant. No new safety signals were observed.
◦Full results from the trial will be presented at the American Heart Association Scientific Sessions (AHA) on November 8th and will be submitted for publication in a peer-reviewed journal.
•Results from a real-world study of patients with established atherosclerotic CV disease treated with Repatha in clinical practice will also be presented at AHA. These data will offer new insights into the effectiveness of Repatha in secondary prevention to reduce the incidence of MACE in these patients. The primary endpoint of this study was the composite of heart attack, stroke and coronary revascularization, and the secondary endpoint was a composite of heart attack, stroke and CV disease death.
•EVOLVE-MI, a Phase 4 study of Repatha administered within 10 days of an acute myocardial infarction to reduce the risk of CV 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 atherosclerotic CV disease and elevated Lp(a).
•The OCEAN(a)-PreEvent trial, a Phase 3 primary prevention CV outcomes study, was initiated and is enrolling patients with elevated LP(a) at risk for a first major CV event.
Rare Disease
UPLIZNA
•In October, additional subgroup data from the Phase 3 MITIGATE trial of UPLIZNA in IgG4-related disease (IgG4-RD), grouped by baseline characteristics and organ involvement (e.g., pancreas, kidney, bile ducts), were presented at the American College of Rheumatology Annual Meeting. These analyses showed benefits comparable to those seen in the overall trial population, supporting UPLIZNA’s potential across the spectrum of IgG4-RD.
•U.S. Food and Drug Administration (FDA) review of the MINT Phase 3 data in patients with generalized myasthenia gravis is ongoing, with a PDUFA date of December 14, 2025.
TEPEZZA
•A Phase 3 study of TEPEZZA in Japan has completed enrollment of patients with chronic/low clinical activity score thyroid eye disease (TED).
•A Phase 3 study evaluating the subcutaneous route of administration of teprotumumab is ongoing in patients with TED.
TAVNEOS
•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 enrolling patients with moderate-to-severe symptomatic burden and low systemic disease activity.
Daxdilimab
•Daxdilimab is a fully human monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7).
•A Phase 2 study of daxdilimab is ongoing in patients with moderate-to-severe active primary discoid lupus erythematosus refractory to standard of care.
•A Phase 2 study of daxdilimab is ongoing in patients with dermatomyositis and antisynthetase inflammatory myositis.
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 is ongoing in patients with Sjögren’s disease.
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
•In October, the FDA approved TEZSPIRE for the add on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
•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.
Rocatinlimab (AMG 451/KHK4083)
•Rocatinlimab is a first-in-class T-cell rebalancing monoclonal antibody that inhibits and reduces OX40-positive pathogenic T-cells.
•The eight study ROCKET Phase 3 program evaluating rocatinlimab in patients with moderate-to-severe atopic dermatitis (AD) has enrolled over 3,300 patients. Enrollment is now complete across all eight studies.
•In September, Amgen and Kyowa Kirin Co., Ltd. announced preliminary top-line results from the ASCEND study evaluating long term maintenance use of rocatinlimab with every four week and every eight-week dosing, in adults and adolescents with moderate to severe AD1. The ongoing ASCEND study will continue to evaluate the long-term safety profile of rocatinlimab.
•ROCKET ASTRO a 52-week study of rocatinlimab is complete. This study evaluated two doses of rocatinlimab (150 mg and 300 mg) as monotherapy and in combination with background low to medium potency topical corticosteroids and/or topical calcineurin inhibitor therapy in adolescent patients with moderate-to-severe AD. The co-primary and secondary efficacy endpoints were met. These endpoints assessed the efficacy at week 24 of rocatinlimab dosed every four weeks. Overall, safety events were consistent with other trials in the ROCKET program.
•A Phase 2 study of rocatinlimab is ongoing in patients with moderate-to-severe asthma.
•A Phase 3 study of rocatinlimab has completed enrollment of patients with prurigo nodularis.
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 systemic lupus erythematosus (SLE), with and without nephritis, and is enrolling adults with refractory rheumatoid arthritis.
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 has completed enrollment of patients with asthma.
Oncology
BLINCYTO / blinatumomab
•The dose-expansion and optimization phase of a Phase 1/2 study of subcutaneous blinatumomab in adult patients with relapsed or refractory CD19-positive Philadelphia chromosome (Ph) negative B-cell precursor acute lymphoblastic leukemia (B-ALL) is complete. The potentially registration-enabling Phase 2 portion of this study was initiated and is enrolling both adults and adolescents.
•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-ALL.
IMDELLTRA / tarlatamab
•IMDELLTRA is the first and only FDA-approved delta-like ligand 3 (DLL3) targeting BiTE molecule.
•In September, results from DeLLphi 303 a Phase 1b study of IMDELLTRA in combination with a PD-L1 inhibitor in the first-line maintenance setting of extensive-stage small cell lung cancer (ES-SCLC) were presented at the World Conference on Lung Cancer and simultaneously published in Lancet Oncology. The addition of IMDELLTRA to a PD-L1 inhibitor as first-line maintenance therapy for ES-SCLC demonstrated a manageable safety profile consistent with the known safety of each component, sustained disease control, and promising median overall survival of 25.3 months, supporting further investigation of this combination in the Phase 3 DeLLphi-305 study.
•In October, additional results from separate arms of the DeLLphi 303 Phase 1b study which evaluated IMDELLTRA in combination with platinum-based chemotherapy and a PD-L1 inhibitor in the first line setting of ES-SCLC were presented at the Annual Congress of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper). IMDELLTRA in combination with first-line chemo-immunotherapy induction followed by IMDELLTRA with PD-L1 inhibitor maintenance therapy demonstrated a manageable safety profile consistent with the known safety of each component and promising initial survival outcomes. In this study median overall survival was not yet reached, the Kaplan-Meier estimate of overall survival at 12 months was 81%. These data support further investigation of this combination in the Phase 3 DeLLphi-312 study.
•The U.S. regulatory submission of DeLLphi 304 a global Phase 3 confirmatory study evaluating IMDELLTRA vs. standard of care in subjects with relapsed ES-SCLC after platinum-based first-line chemotherapy was accepted with a PDUFA date of December 18, 2025. Regulatory reviews are also underway in a number of additional geographies.
•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 has completed enrollment of patients with first-line ES-SCLC in the maintenance setting.
◦DeLLphi-306, a Phase 3 study of IMDELLTRA following concurrent chemoradiation therapy, is enrolling 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, is enrolling patients.
◦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, is enrolling 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 ES-SCLC.
◦DeLLphi-312, a Phase 3 study of first-line IMDELLTRA in combination with carboplatin, etoposide and durvalumab, 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 castrate resistant prostate cancer (mCRPC) who have previously been treated with taxane-based chemotherapy.
•XALience, a Phase 3 study of xaluritamig in combination with abiraterone versus investigator’s choice therapy was initiated in 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 enrolling patients with high-risk biochemically recurrent prostate cancer after definitive therapy.
•A Phase 1b study of xaluritamig in combination with androgen receptor pathway inhibitors was initiated and is enrolling patients with metastatic hormone-sensitive prostate cancer.
Bemarituzumab
•Bemarituzumab is a first-in-class fibroblast growth factor receptor 2b (FGFR2b) targeting monoclonal antibody.
•In October, the full results from both the interim analysis and descriptive follow-up analysis of the Phase 3 FORTITUDE-101 clinical trial of bemarituzumab plus chemotherapy (mFOLFOX6) in first-line gastric cancer were presented at ESMO (Free ESMO Whitepaper). The results showed:
◦At the primary analysis bemarituzumab plus chemotherapy led to a statistically significant improvement in overall survival (OS) with a median OS of 17.9 months in the bemarituzumab + mFOLFOX6 arm versus 12.5 months in the placebo + mFOLFOX6 arm, Hazard Ratio (HR) (95%): 0.61 (0.43 – 0.86; P = 0.005).
◦At the descriptive follow-up analysis, median OS in the bemarituzumab plus mFOLFOX6 arm was 14.5 months (95% C.I 13.0-17.9 months) while the median OS in the placebo plus mFOLFOX6 arm was 13.2 months (95% CI 10.9-14.7 months), HR (95%): 0.82 (0.62-1.08).
•FORTITUDE-102, a Phase 1b/3 study of bemarituzumab plus chemotherapy and nivolumab in patients with first-line gastric cancer was stopped.
•FORTITUDE-103, a Phase 1b/2 study of bemarituzumab plus oral chemotherapy regimens with or without nivolumab, has completed enrollment of patients with first-line gastric cancer.
•FORTITUDE-301, a Phase 1b/2 basket study of bemarituzumab monotherapy, is ongoing in patients with solid tumors with FGFR2b overexpression.
AMG 193
•AMG 193 is a first-in-class small molecule methylthioadenosine (MTA)-cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor.
•A Phase 2 study of AMG 193 is enrolling patients with methylthioadenosine phosphorylase (MTAP)-null previously treated advanced non-small cell lung cancer (NSCLC).
•A Phase 1/1b/2 study of AMG 193 is enrolling 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 is enrolling patients with advanced MTAP-null thoracic malignancies.
•A Phase 1b study of AMG 193 in combination with other therapies is enrolling 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 enrolling patients with NSCLC, ovarian cancer, or breast cancer.
Biosimilars
•A randomized, double-blind pharmacokinetic similarity study of ABP 206 compared with OPDIVO (nivolumab) in patients with resected stage III or stage IV melanoma in the adjuvant setting met the primary endpoint of pharmacokinetic similarity.
•A randomized, double-blind comparative clinical study of ABP 206 compared with OPDIVO is enrolling patients with treatment-naïve unresectable or metastatic melanoma.
•A randomized, double-blind pharmacokinetic similarity study of ABP 234 compared with KEYTRUDA (pembrolizumab) is enrolling 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 enrolling 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.
Rocatinlimab, formerly AMG 451/KHK4083, is being developed in collaboration with Kyowa Kirin.
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.
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, NOV 4, 2025, View Source [SID1234659343])