On August 4, 2026 Amgen (NASDAQ:AMGN) reported financial results for the second quarter of 2026.

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"Our results demonstrate strong performance across our business. Our six key growth drivers grew 26% year over year, generating nearly 70% of second-quarter product sales. As we expand the potential of our existing medicines through new indications and advance the next wave of pipeline molecules through Phase 3, we remain confident in our ability to deliver growth well into the next decade," said Robert A. Bradway, chairman and chief executive officer.

Key results include:
•For the second quarter, total revenues increased 10% to $10.1 billion in comparison to the second quarter of 2025.
◦Product sales grew 9%, driven by volume growth.
◦Twenty-two products delivered at least double-digit sales growth in the second quarter.
◦Seventeen products are annualizing at more than $1 billion based on second quarter sales.
•GAAP earnings per share (EPS) increased 65% from $2.65 to $4.37 for the second quarter, driven by higher revenues.
◦For the second quarter, GAAP operating income increased from $2.7 billion to $3.5 billion, and GAAP operating margin increased 6.5 percentage points to 36.8%.
•Non-GAAP EPS increased 4% from $6.02 to $6.29 for the second quarter, primarily driven by higher revenues, partially offset by higher operating expenses and higher income tax expense.
◦For the second quarter, non-GAAP operating income increased from $4.3 billion to $4.6 billion, and non-GAAP operating margin decreased 0.5 percentage points to 48.4%.
•The Company generated $3.5 billion of free cash flow in the second quarter of 2026 versus $1.9 billion in the second quarter of 2025. The increase reflects the final repatriation tax payment in the second quarter of 2025 and current period business performance, partially offset by timing of working capital.

Product Sales Performance

General Medicine

•Repatha (evolocumab) sales increased 37% year-over-year to $953 million in the second quarter, driven by volume growth.

•EVENITY (romosozumab-aqqg) sales increased 38% year-over-year to $714 million in the second quarter, driven by volume growth.

•Prolia (denosumab) sales decreased 32% year-over-year to $759 million in the second quarter, driven by 20% lower volume and 12% lower net selling price as multiple biosimilars have launched globally with more biosimilars expected.

Rare Disease

•TEPEZZA (teprotumumab-trbw) sales increased 14% year-over-year to $576 million in the second quarter, primarily driven by 6% higher net selling price and 6% volume growth.

•KRYSTEXXA (pegloticase) sales increased 15% year-over-year to $400 million in the second quarter, driven by 23% higher net selling price, partially offset by lower inventory levels.

•UPLIZNA (inebilizumab-cdon) sales increased 90% year-over-year to $335 million in the second quarter, primarily driven by volume growth.

•TAVNEOS (avacopan) sales increased 36% year-over-year to $150 million in the second quarter, driven by volume growth. We continue to engage with the U.S. Food and Drug Administration (FDA) and believe that TAVNEOS demonstrates clinical effectiveness and a favorable benefit-risk profile.

Inflammation

•TEZSPIRE (tezepelumab-ekko) sales increased 42% year-over-year to $486 million in the second quarter, driven by volume growth.

•Otezla (apremilast) sales decreased 21% year-over-year to $491 million in the second quarter, primarily driven by 9% lower net selling price and 6% lower volume.

•Enbrel (etanercept) sales decreased 4% year-over-year to $580 million in the second quarter, primarily driven by 22% lower net selling price, partially offset by 16% favorable changes to estimated sales deductions. 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 17% year-over-year to $155 million in the second quarter, primarily driven by volume growth.

•PAVBLU (aflibercept-ayyh) sales increased 121% year-over-year to $287 million in the second quarter, primarily driven by volume growth based on its position as the only commercially available biosimilar to EYLEA in the U.S. during this period.

Oncology

•BLINCYTO (blinatumomab) sales increased 23% year-over-year to $472 million in the second quarter, primarily driven by 16% volume growth.

•IMDELLTRA (tarlatamab-dlle)/IMDYLLTRA (tarlatamab) sales increased 115% year-over-year to $288 million in the second quarter, primarily driven by volume growth.

•Vectibix (panitumumab) sales increased 11% year-over-year to $338 million in the second quarter, primarily driven by volume growth.

•KYPROLIS (carfilzomib) sales decreased 17% year-over-year to $314 million in the second quarter, driven by lower volume.

•LUMAKRAS/LUMYKRAS (sotorasib) sales increased 23% year-over-year to $111 million in the second quarter, primarily driven by volume growth.

•Nplate (romiplostim) sales increased 17% year-over-year to $430 million in the second quarter, driven by 13% volume growth and higher net selling price.

•XGEVA (denosumab) sales decreased 34% year-over-year to $352 million in the second quarter, primarily driven by 22% lower volume and 8% lower net selling price as multiple biosimilars have launched globally with more biosimilars expected.

•MVASI (bevacizumab-awwb) sales decreased 20% year-over-year to $153 million in the second quarter, driven by 16% lower net selling price and lower volume.

Established Products

•Our established products, which consist of Aranesp (darbepoetin alfa), Neulasta (pegfilgrastim), and Parsabiv (etelcalcetide), generated $632 million of sales in the second quarter. Sales increased 19% year-over-year, driven by 15% higher net selling price and 2% volume growth.

Product Sales Detail by Product and Geographic Region
$Millions, except percentages Q2 ’26 Q2 ’25 YOY Δ
U.S.
ROW TOTAL TOTAL TOTAL
Repatha
$ 510 $ 443 $ 953 $ 696 37%
EVENITY
550 164 714 518 38%
Prolia
478 281 759 1,122 (32%)
TEPEZZA
520 56 576 505 14%
KRYSTEXXA
399 1 400 349 15%
UPLIZNA
317 18 335 176 90%
TAVNEOS
143 7 150 110 36%
Ultra-Rare products(1)
144 5 149 183 (19%)
TEZSPIRE
486 — 486 342 42%
Otezla
431 60 491 618 (21%)
Enbrel
574 6 580 604 (4%)
AMJEVITA/AMGEVITA
26 129 155 133 17%
PAVBLU
280 7 287 130 *
WEZLANA/WEZENLA
— 61 61 35 74%
BLINCYTO
285 187 472 384 23%
IMDELLTRA/IMDYLLTRA
233 55 288 134 *
Vectibix
167 171 338 305 11%
KYPROLIS
201 113 314 378 (17%)
LUMAKRAS/LUMYKRAS
62 49 111 90 23%
Nplate
275 155 430 369 17%
XGEVA
187 165 352 532 (34%)
MVASI
106 47 153 191 (20%)
Aranesp
94 258 352 359 (2%)
Neulasta
164 15 179 82 *
Parsabiv
54 47 101 92 10%
Other products(2)
304 47 351 334 5%
Total product sales $ 6,990 $ 2,547 $ 9,537 $ 8,771 9%

Operating Expense, Operating Margin and Tax Rate Analysis
On a GAAP basis:
•Total Operating Expenses remained relatively unchanged year-over-year for the second quarter. Cost of Sales as a percentage of product sales decreased 4.8 percentage points, driven by lower amortization expense from acquisition-related assets, partially offset by higher profit share expense, higher manufacturing costs and changes in our sales mix. Research & Development (R&D) expenses increased 7% driven by higher spend in both Later-Stage Clinical Programs, primarily those related to MariTide, and Marketed Product Support. Selling, General & Administrative (SG&A) expenses increased 3% driven by higher general and administrative expenses and higher commercial product-related expenses. Other operating expenses for the second quarter included litigation expenses.
•Operating Margin as a percentage of product sales increased 6.5 percentage points to 36.8%.
•Tax Rate increased 5.5 percentage points for the second quarter primarily driven by the change in earnings mix, including lower amortization expense from acquisition-related assets.
On a non-GAAP basis:
•Total Operating Expenses increased 11% year-over-year for the second quarter. Cost of Sales as a percentage of product sales increased 1.9 percentage points, driven by higher profit share expense, higher manufacturing costs, and changes in our sales mix. R&D expenses increased 10% primarily driven by higher spend in both Later-Stage Clinical Programs, primarily those related to MariTide, and Marketed Product Support. SG&A expenses increased 4% primarily driven by higher general and administrative expenses and higher commercial product-related expenses.
•Operating Margin as a percentage of product sales decreased 0.5 percentage points for the second quarter to 48.4%.
•Tax Rate increased 1.4 percentage points for the second quarter primarily driven by the change in earnings mix and net unfavorable items in the current-year period.
$Millions, except percentages GAAP Non-GAAP
Q2 ’26 Q2 ’25 YOY Δ Q2 ’26 Q2 ’25 YOY Δ
Cost of Sales $ 2,811 $ 3,011 (7%) $ 1,874 $ 1,551 21%
% of product sales 29.5 % 34.3 % (4.8) pts. 19.6 % 17.7 % 1.9 pts.
Research & Development $ 1,868 $ 1,744 7% $ 1,851 $ 1,685 10%
% of product sales 19.6 % 19.9 % (0.3) pts. 19.4 % 19.2 % 0.2 pts.
Selling, General & Administrative $ 1,745 $ 1,691 3% $ 1,717 $ 1,650 4%
% of product sales 18.3 % 19.3 % (1.0) pts. 18.0 % 18.8 % (0.8) pts.
Other $ 116 $ 77 51% $ — $ — N/A
Total Operating Expenses $ 6,540 $ 6,523 0% $ 5,442 $ 4,886 11%
Operating Margin
Operating income as % of product sales
36.8 % 30.3 % 6.5 pts. 48.4 % 48.9 % (0.5) pts.
Tax Rate 14.2 % 8.7 % 5.5 pts. 15.6 % 14.2 % 1.4 pts.
pts: percentage points
N/A = not applicable

Cash Flow and Balance Sheet
•The Company generated $3.5 billion of free cash flow in the second quarter of 2026 versus $1.9 billion in the second quarter of 2025. The increase reflects the final repatriation tax payment in the second quarter of 2025 and current period business performance, partially offset by timing of working capital.
•The Company declared a second quarter 2026 dividend on March 4, 2026 of $2.52 per share that was paid on June 5, 2026 to all stockholders of record as of May 15, 2026, representing a 6% increase from the same period in 2025.
•During the second quarter of 2026, there were no repurchases of shares of common stock under our stock repurchase program.
•Cash and cash equivalents totaled $14.0 billion and debt outstanding totaled $57.3 billion as of June 30, 2026.
$Billions, except shares Q2 ’26 Q2 ’25 YOY Δ
Operating Cash Flow $ 4.0 $ 2.3 $ 1.7
Capital Expenditures $ 0.5 $ 0.4 $ 0.1
Free Cash Flow $ 3.5 $ 1.9 $ 1.6
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 6/30/26 12/31/25 YTD Δ
Cash and Cash Equivalents $ 14.0 $ 9.1 $ 4.9
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 $38.2 billion to $39.4 billion.
•On a GAAP basis, EPS in the range of $15.80 to $17.08, and a tax rate in the range of 14.5% to 16.0%.
•On a non-GAAP basis, EPS in the range of $22.30 to $23.50, 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.

Second 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). MariTide’s long-acting design supports starting with monthly dosing, and staying on MariTide with as few as 4 or 6 doses per year.
•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, is enrolling 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, to evaluate the maintenance of weight loss with monthly, every eight-week or quarterly dosing, is enrolling 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, to evaluate the maintenance of weight loss with monthly and every eight-week dosing, is enrolling 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 is enrolling adults living with obesity or overweight with elevated liver fat.

AMG 513
•Future development of AMG 513 will be discontinued.
•A Phase 1 study of AMG 513 in adults living with obesity will remain ongoing to follow enrolled participants through completion of the study.

Repatha
•In May, results from a new analysis of the Phase 3 VESALIUS-CV pre-cardiovascular event trial in a subgroup of patients who had a prior percutaneous coronary intervention (PCI) were presented at the European Paris Course on Revascularization (EuroPCR) and simultaneously published in Circulation. In this subset of 3,627 patients who had prior PCI, Repatha:
◦demonstrated a 30% relative reduction in the risk of a composite of coronary heart disease death, heart attack or ischemic stroke (3-P MACE).
◦demonstrated an 18% relative reduction in a broader composite that also included ischemia-driven revascularization (4-P MACE).
◦reduced the relative risk of heart attack by 50%, with the effect seen as soon as 6 months after randomization.
◦was associated with nominal 34% decreased risk of cardiovascular death and 24% decreased risk of all-cause death.
•In June, results from a new analysis of VESALIUS-CV in a subgroup of patients with high-risk diabetes with and without known atherosclerosis were presented at the American Diabetes Association Scientific Sessions and simultaneously published in Diabetes Care. In this subset of 6,002 patients with high-risk diabetes with and without known atherosclerosis, Repatha:
◦demonstrated a 29% relative reduction in the risk of a composite of coronary heart disease death, heart attack or ischemic stroke (3-P MACE).
◦demonstrated a 21% relative reduction in a broader composite that also included ischemia-driven revascularization (4-P MACE).
◦was associated with a nominal 21% decreased risk of all-cause death.
•Further data from three new pre-specified analyses of the VESALIUS-CV study demonstrating the protective effects of Repatha on total cardiovascular events, myocardial infarction, and fatal outcomes, will be presented as oral abstracts at the European Society of Cardiology (ESC) Congress in August 2026.
•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, is enrolling patients with atherosclerotic CV disease and elevated Lp(a).

Rare Disease
UPLIZNA
•In June, new open-label extension data from the Phase 3 MITIGATE study in patients with immunoglobulin G4-related disease (IgG4-RD) were presented at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress. Key findings included:
◦sustained response and disease control with continued UPLIZNA treatment at Year 1 of the open label period (OLP).
◦100% of patients remained flare-free and 71.4% of patients achieved both flare-free and glucocorticoid-free complete remission with continued UPLIZNA treatment through Year 1 of the OLP.
◦UPLIZNA continued to demonstrate a safety profile consistent with the established safety profile of UPLIZNA across all approved indications.
◦efficacy and safety outcomes support the longer-term use of UPLIZNA for the treatment of IgG4-RD.
•MERCURY, a Phase 2/3 study of UPLIZNA, was initiated in patients with autoimmune hepatitis (AIH).
•A Phase 3 study of UPLIZNA in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) will be initiated H2 2026 – H1 2027.

TEPEZZA
•A Phase 3 study of TEPEZZA in Japan is ongoing in patients with chronic/low clinical activity score thyroid eye disease (TED).

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.
•The Company continues to engage the FDA regarding the Center for Drug Evaluation and Research’s request to voluntarily withdraw TAVNEOS from the U.S. market. On June 1, 2026, the Company requested a hearing to discuss this topic and submitted supporting materials to the FDA on July 23, 2026. The Company believes that these materials support a favorable benefit-risk profile of TAVNEOS for patients with AAV.
•A Phase 3, open-label study of TAVNEOS in combination with rituximab or a cyclophosphamide-containing regimen has completed enrollment of patients from 6 years to < 18 years of age with active AAV (Granulomatosis with Polyangiitis (GPA)/Microscopic Polyangiitis (MPA)).

Dazodalibep
•Dazodalibep is a fusion protein that inhibits CD40 ligand (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 732
•AMG 732 is an insulin-like growth factor-1 receptor (IGF-1R) targeting monoclonal antibody.
•A Phase 2 study of AMG 732 has completed enrollment of patients with moderate-to-severe active TED.

Inflammation
TEZSPIRE
•A Phase 3 study of TEZSPIRE is ongoing in patients with eosinophilic esophagitis. Study completion is expected in H2 2026.
•Two Phase 3 studies of TEZSPIRE are enrolling adults with moderate to very severe chronic obstructive pulmonary disease (COPD) and a blood eosinophil count (BEC) ≥ 150 cells/µL.

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 autoimmune disease is ongoing in adults with systemic lupus erythematosus (SLE), with and without nephritis.

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.

Sunakiment (AMG 104/AZD8630)
•Sunakiment is an inhaled anti-thymic stromal lymphopoietin (TSLP) fragment antigen-binding (Fab) protein.

•LEVANTE, a Phase 2 study of sunakiment in patients with asthma, is complete. The results of this dose-ranging study were encouraging and informative for dose selection. In collaboration with AstraZeneca, the Company is planning a Phase 3 development program in asthma.

Oncology
BLINCYTO/blinatumomab
•Golden Gate, a Phase 3 study of BLINCYTO alternating with low-intensity chemotherapy, has completed enrollment of 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 in both adults and adolescents with relapsed or refractory CD19-positive Philadelphia chromosome (Ph) negative B-ALL has paused enrollment of new patients following a partial clinical hold by the FDA.
•A Phase 1b/2 study of subcutaneous blinatumomab in pediatric patients with relapsed or refractory and minimal residual disease positive (MRD+) B-ALL has paused enrollment of new patients following a partial clinical hold by the FDA.
•Discussions are underway with the FDA on a path forward to reopen both subcutaneous blinatumomab studies.

IMDELLTRA/tarlatamab
•IMDELLTRA is the first and only FDA-approved delta-like ligand 3 (DLL3) targeting BiTE molecule.
•In May, the European Commission approved IMDYLLTRA as a monotherapy for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) who require systemic therapy following disease progression on or after first-line platinum-based chemotherapy.
•Also in May, the China National Medical Products Administration (NMPA) granted full approval to IMDELLTRA for the treatment of second-line ES-SCLC and will be commercialized by BeOne in China.
•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, is ongoing in 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, has completed its primary analysis. The primary analysis demonstrated that extended dosing intervals can result in durable responses with encouraging survival, with a safety profile in line with expectation. The Company will discuss these new data with regulators and detailed results will be presented at an upcoming medical congress.
◦DeLLphi-310, a Phase 1b study of IMDELLTRA in combination with YL201, a B7-H3 targeting antibody-drug conjugate (ADC), with or without a PD-L1 inhibitor, has completed 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 ADC, with and without a PD-L1 inhibitor, is enrolling patients with ES-SCLC
◦DeLLphi-315, a Phase 3 study of subcutaneous tarlatamab, was initiated in patients with second-line ES-SCLC.

Xaluritamig (AMG 509)
•Xaluritamig is a first-in-class BiTE molecule targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1).
•XALute, a Phase 3 study of xaluritamig, has completed enrollment of 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 enrolling patients with mCRPC who have not yet received taxane-based chemotherapy. This study is 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 in patients 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 is enrolling 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.

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 non-small cell lung cancer (NSCLC).

Nplate
•PROCLAIM, a Phase 3 study of Nplate for the treatment of chemotherapy-induced thrombocytopenia (CIT), is ongoing in patients with NSCLC, ovarian cancer, or breast cancer.
•ROMISTER, a Phase 3 study of Nplate plus predniso(lo)ne compared with predniso(lo)ne alone, was initiated in patients with untreated primary immune thrombocytopenia (ITP).

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) is ongoing in patients with early-stage non-squamous NSCLC as adjuvant treatment.
•A randomized, double-blind combined pharmacokinetic/comparative clinical study of ABP 234 compared with 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 with OCREVUS (ocrelizumab) has completed enrollment of patients with relapsing-remitting multiple sclerosis.
•A randomized, double-blind, comparative clinical study of ABP 938 (8 mg) compared with EYLEA HD (aflibercept) was initiated and is enrolling patients with neovascular age-related macular degeneration.

TEZSPIRE is being developed in collaboration with AstraZeneca.
Sunakiment (AMG 104/AZD8630) 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 DLL3 targeting antibody-drug conjugate being developed by Zai Lab Limited.
Etakafusp alfa (AB248) is a novel CD8+ T cell selective IL-2 being developed by Asher Biotherapeutics.

(Press release, Amgen, AUG 4, 2026, View Source [SID1234669653])

On August 4, 2026 Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, reported its financial results for the second quarter ended June 30, 2026, and provided a business update.

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"We delivered another quarter of strong commercial results, with both our medicines now annualizing at well over $200 million each and positioned for further growth," said Michael A. Metzger, Chief Executive Officer. "Notably, we achieved $55 million in Revuforj net revenue and the sixth consecutive quarter of double-digit net revenue and prescription growth, highlighting our leadership in menin inhibition, robust demand in both NPM1 and KMT2A, and an increasing average treatment duration. Niktimvo net revenue grew to $60 million this quarter, underscoring the benefits of its unique mechanism of action in cGVHD and the substantial commercial opportunity."

Mr. Metzger continued, "We’ve made excellent progress advancing our growing pipeline targeting multiple blockbuster opportunities, including two recently announced assets with first- and best-in-class potential in EGFR-mutated NSCLC and myelofibrosis. We are positioned to be first to frontline AML with Revuforj, driven by strong global site initiation and patient enrollment in our pivotal trials. We also have multiple near-term catalysts with Niktimvo Phase 2 data in IPF and frontline cGVHD expected in the fourth quarter, plus additional practice-informing and potentially guideline-enabling Revuforj data in acute leukemia."

Recent Business Highlights and Anticipated Milestones

Revuforj (revumenib)

•
Achieved $54.7 million in Revuforj net revenue in the second quarter of 2026, a 91% increase over the second quarter of 2025 and a 12% increase over the first quarter of 2026. Total prescriptions were approximately 1,500 in the second quarter of 2026, an approximate 121% increase over the second quarter of 2025 and a 15% increase over the first quarter of 2026. The net revenue and prescription growth reflects an increasing average treatment duration, primarily driven by a growing pool of patients receiving Revuforj for an extended period in the post-transplant setting.
•
Advanced the Company’s scientific leadership in menin inhibition with the presentation of 16 revumenib abstracts at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the European Hematology Association (EHA) (Free EHA Whitepaper) annual meetings in June 2026. The data presented span multiple acute leukemia subtypes and settings, including frontline and post-transplant maintenance.
•
Published data from the Phase 1/2 SAVE trial of an all-oral combination of revumenib, decitabine/cedazuridine, and venetoclax in relapsed/refractory (R/R) NPM1-mutated (NPM1m), KMT2A-rearranged (KMT2Ar), and NUP98-rearranged (NUP98r) acute myeloid leukemia (AML) in the Journal of Clinical Oncology in June 2026. The results showed deep and durable remissions in a heavily pretreated patient population. The ORR was 88% (37/42), CRc was 71% (30/42), and CR/CRh was 60% (25/42). 80% of evaluable CRc responders were measurable residual disease (MRD) negative. 45% (19/42) of patients proceeded to a transplant and 63% (12/19) resumed revumenib post-transplant.
•
Published preclinical revumenib data showing that menin is a novel dependency in proliferative megakaryocytes, major drivers of myelofibrosis (MF), in Cancer Cell in July 2026. These data provide the basis for the Company’s plans to develop SNDX-62122, an internally developed, next-generation menin inhibitor, for MF.
•
The Company expects to have a major presence at upcoming medical meetings in the second half of 2026 with the presentation of new/updated revumenib data including:
•
Real-world evidence from multiple centers
•
Post-transplant maintenance data

•
Frontline data from the BEAT AML trial of revumenib in combination with venetoclax/azacitidine in NPM1m and KMT2Ar AML
•
Frontline data from the Phase 1/2 SAVE trial of an all-oral combination of revumenib, decitabine/cedazuridine, and venetoclax in NPM1m, KMT2Ar, or NUP98r AML
•
Frontline data from the Phase 1 trial of revumenib in combination with intensive chemotherapy in NPM1m, KMT2Ar, or NUP98r AML
•
Multiple clinical trials evaluating revumenib across the acute leukemia treatment continuum are ongoing, such as:
•
EVOLVE-2: A pivotal, Phase 3, randomized, double-blind, placebo-controlled trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed NPM1m (primary efficacy analysis population) and KMT2Ar AML patients who are unfit for intensive chemotherapy. The trial is being conducted in collaboration with the HOVON network, a leading cooperative clinical trial group with extensive experience studying novel therapies for hematologic malignancies.
•
REVEAL-ND: A pivotal, Phase 3, randomized, double-blind, placebo-controlled trial of revumenib in combination with intensive chemotherapy in newly diagnosed NPM1m AML patients.
•
SAVE: A Phase 1/2 trial evaluating an all-oral combination of revumenib with venetoclax and decitabine/cedazuridine in pediatric and adult patients with newly diagnosed and R/R AML or mixed-lineage acute leukemia harboring either NPM1m, KMT2Ar, or NUP98r alterations. The trial is being conducted by investigators from MD Anderson Cancer Center.
•
Intensive chemotherapy: Two ongoing Phase 1 trials evaluating the combination of revumenib with intensive chemotherapy (7+3) in newly diagnosed NPM1m or KMT2Ar acute leukemia patients.
•
BEAT AML: A Phase 1 trial evaluating the combination of revumenib with venetoclax and azacitidine in newly diagnosed older adults (≥60 years) with NPM1m or KMT2Ar AML. The trial is being conducted as part of the Leukemia & Lymphoma Society’s Beat AML Master Clinical Trial.
•
Post-transplant maintenance: A Phase 1 trial evaluating the safety and preliminary efficacy of revumenib as post-transplant maintenance in patients with KMT2Ar or NPM1m acute leukemia. The trial is being conducted by investigators from the City of Hope Medical Center.
•
Break Through Cancer: A Phase 2 trial studying whether the combination of revumenib and venetoclax can eliminate MRD in patients with AML and extend progression-free survival. The trial is being conducted by Break Through Cancer, a collaboration between leading U.S. cancer research centers.
•
INTERCEPT: A Phase 1 trial evaluating the use of novel therapies, including revumenib, to target MRD and early relapse in AML. The trial is being conducted by the Australasian Leukaemia and Lymphoma Group as part of the INTERCEPT AML master clinical trial.
•
The Company expects the RAVEN trial to initiate in the second half of 2026. RAVEN is a Phase 2 collaborative trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed KMT2Ar patients who would be considered eligible, or fit, for intensive chemotherapy.
•
The Company expects the MenTain Phase 2 trial to initiate around the end of 2026. MenTain will be the first randomized, placebo-controlled trial specifically focused on evaluating revumenib as post-transplant maintenance.
•
The Company expects to publish safety and efficacy data from R/R NUP98r acute leukemia patients treated with revumenib in the fourth quarter of 2026.
Niktimvo (axatilimab-csfr)

•
Achieved $60.3 million in Niktimvo net revenue in the second quarter of 2026, a 67% increase over the second quarter of 2025 and a 9% increase over the first quarter of 2026. Syndax and Incyte are co-commercializing Niktimvo. Syndax records 50% of the Niktimvo net commercial profit, defined as net product revenue minus the cost of sales and commercial expenses. Syndax’s share of the Niktimvo product contribution, reported as collaboration revenue, was $18.1 million in the second quarter of 2026.
•
Two trials evaluating axatilimab in combination with standard of care therapies in newly diagnosed chronic graft-versus-host disease (cGVHD) patients are ongoing, including:
o
A Phase 2, open-label, randomized, multicenter trial of axatilimab in combination with ruxolitinib in patients ≥ 12 years of age with newly diagnosed cGVHD. Topline data are anticipated in the fourth quarter of 2026.o
A pivotal Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of axatilimab in combination with corticosteroids in patients ≥ 12 years of age with newly diagnosed cGVHD. Topline data are anticipated in early 2028.
•
The Company anticipates topline data from MAXPIRe, a Phase 2, 26-week randomized, double-blinded, placebo-controlled trial of axatilimab on top of standard of care in patients with idiopathic pulmonary fibrosis in the fourth quarter of 2026.
Pipeline Assets

SNDX-4321

•
In July 2026, the Company announced the expansion of its pipeline with SNDX-4321, a mutant-selective, CNS-penetrant, allosteric EGFR inhibitor. SNDX-4321 is in development for non-small cell lung cancer (NSCLC) patient populations with significant unmet needs, such as those with L858R mutations, CNS metastases, atypical activating mutations, or acquired resistance to current therapies. In contrast to ATP-site directed third and fourth generation EGFR inhibitors, SNDX-4321 is a novel allosteric inhibitor which binds at a pocket adjacent to the ATP site that is only accessible in the presence of L858R and certain other EGFR mutations.
•
The Company expects to submit an investigational new drug (IND) application for SNDX-4321 by the end of 2026 and to initiate a Phase 1 trial in EGFRm NSCLC in 2027.
SNDX-62122

•
In July 2026, the Company announced the selection of SNDX-62122, a next-generation menin inhibitor, for development in MF. SNDX-62122 is the first candidate from a library of internally developed, wholly owned next-generation menin inhibitors that the Company intends to advance into new areas.
•
The Company expects to submit an IND and initiate a Phase 1 trial of SNDX-62122 in MF in 2027. The development of SNDX-62122 will be informed by a Phase 1/2 proof-of-principle trial of revumenib in MF that is expected to initiate in the fourth quarter of 2026 with initial clinical data expected in the second half of 2027.
Second Quarter 2026 Financial Results

As of June 30, 2026, Syndax had cash, cash equivalents, and short- and long-term investments of $575.1 million and 89.4 million common shares and prefunded warrants outstanding.

Total revenue for the second quarter of 2026 was $72.8 million, which consisted of $54.7 million in Revuforj net revenue and $18.1 million in Niktimvo collaboration revenue. The Niktimvo collaboration revenue is derived from the $60.3 million in Niktimvo net revenue that was previously reported by the Company’s partner Incyte for the second quarter 2026. Syndax records 50% of the Niktimvo net commercial profit, defined as net revenue (recorded by Incyte) minus the cost of sales and commercial expenses.

Second quarter 2026 research and development expenses increased to $68.0 million from $62.2 million for the comparable prior year period. The year-over-year change was primarily the result of increased expenses associated with frontline trials evaluating revumenib in combination with standard-of-care agents in the treatment of AML.

Second quarter 2026 selling, general and administrative expenses decreased to $41.5 million from $43.8 million for the comparable prior year period. The year-over-year change was primarily the result of decreased commercial expenses due to launch costs incurred in the second quarter of 2025 for Revuforj and Niktimvo that were not incurred in the same period in 2026.

For the six months ended June 30, 2026, Syndax reported a net loss attributable to common stockholders of $49.4 million, or $0.55 per share, compared to a net loss attributable to common stockholders of $71.8 million, or $0.83 per share, for the comparable prior year period.

Financial Guidance

For the full year of 2026, the Company continues to expect total research and development plus selling, general and administrative expenses to be approximately $400 million, excluding the impact of $50 million in estimated non-cash stock compensation expense.

Syndax expects that its cash, cash equivalents and short-term investments, combined with its anticipated product revenue, collaboration revenue and interest income, will enable the Company to reach profitability.

Conference Call and Webcast

In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, August 4, 2026.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website. Alternatively, the conference call may be accessed through the following:

Conference ID: Syndax2Q26
Domestic Dial-in Number: 800-590-8290
International Dial-in Number: 240-690-8800
Live webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available on the Investors section of the Company’s website at www.syndax.com approximately 24 hours after the conference call and will be available for 90 days following the call.

About Revuforj (revumenib)

Revuforj (revumenib) is the first and only menin inhibitor that is FDA approved for the treatment of adult and pediatric patients one year and older with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options or R/R acute leukemia with a KMT2A translocation as determined by an FDA-authorized test.

Multiple trials of revumenib are ongoing or planned across the treatment landscape, including in combination with standard of care therapies in newly diagnosed patients with NPM1m or KMT2Ar AML.

About Niktimvo (axatilimab-csfr)

Niktimvo (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs).

In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications.

Axatilimab is being studied in frontline combination trials in chronic GVHD, including a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774). Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256).

(Press release, Syndax, AUG 4, 2026, View Source [SID1234669668])

On August 4, 2026 OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on developing novel precision medicines, reported financial results for the second quarter ended June 30, 2026, and provided recent business highlights.

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"Following our strategic transformation earlier this year, we continue to advance our next-generation PI3Kα pan-mutant selective inhibitor pipeline, which we believe represents the most compelling opportunity to deliver differentiated therapies across PI3Kα-driven diseases," said Nicholas Saccomano, Ph.D., President and Chief Executive Officer of OnKure. "Both OKI-355 and OKI-345 continue to advance through IND-enabling activities and remain on track for planned IND submissions in the first half of 2027. We believe the combination of our chemistry platform and deep understanding of PI3Kα biology positions us to develop differentiated therapies with the potential to meaningfully improve outcomes for patients. Our recent Key Opinion Leader event reinforced the scientific rationale underpinning our strategy and highlighted the significant opportunity for next-generation PI3Kα pan-mutant selective inhibitors to overcome the limitations of current therapies across multiple disease settings."

Vascular Anomalies

OnKure continues to advance OKI-355, a next-generation PI3Kα pan-mutant-selective inhibitor candidate announced in March 2026 to lead its development pipeline in vascular anomalies. OKI-355 has been designed to selectively inhibit mutant PI3Kα while sparing wildtype PI3Kα, potentially enabling a wider therapeutic index and avoidance of class-limiting toxicities. High and sustained target coverage across all hotspot PI3Kα mutations can support the potential for deep and durable responses in vascular anomalies. OnKure plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for OKI-355 in the first half of 2027.

Additionally, earlier this year, OnKure initiated a discovery research program to expand its vascular anomalies pipeline beyond targeting PI3Kα.

Breast Cancer

In breast cancer, OnKure continues to advance OKI-345, a next-generation PI3Kα pan-mutant-selective inhibitor candidate selected in March 2026. OKI-345 has been designed to selectively inhibit mutant PI3Kα while sparing wildtype PI3Kα, potentially enabling a wider therapeutic index and avoidance of class-limiting toxicities. High and sustained target coverage across all hotspot PI3Kα mutations can support the potential for deep and durable responses in breast cancer, both as monotherapy and in combination. OnKure plans to submit an IND application to the FDA for OKI-345 in the first half of 2027.

Scientific Engagement

OnKure recently hosted a virtual Key Opinion Leader event titled "Selectivity Matters and Pan-Mutant Allosteric Inhibition Delivers," featuring Benjamin F. Cravatt, Ph.D., of Scripps Research, and Robert Abraham, Ph.D., Chief Scientific Officer of Engine Biosciences. The discussion explored the scientific rationale supporting next-generation PI3Kα pan-mutant selective inhibitors, including the importance of PI3Kα selectivity, the potential to overcome limitations of current therapies, and the Company’s structure-based drug design approach.

OnKure also participated as an exhibitor and sponsor at the International Society for the Study of Vascular Anomalies (ISSVA) World Congress 2026 in Philadelphia, held in May.

Financial Results

Cash position: As of June 30, 2026, the Company reported cash, cash equivalents, and marketable securities of $176.4 million, which is expected to provide cash runway into 2029.

Research and development (R&D) expenses: R&D expenses were $12.6 million for both the second quarter of 2026 and the second quarter of 2025. During the second quarter of 2026, an increase in clinical trial and outsourced manufacturing expenses was offset by a decrease in outsourced preclinical R&D expenses.

General and Administrative (G&A) expenses: G&A expenses were $4.3 million for the second quarter of 2026, compared to $3.7 million for the second quarter of 2025. The increase of $0.6 million was primarily driven by increases in personnel-related and consulting costs.

Net loss and net loss per share were $15.3 million, or $0.31 per share, for the second quarter of 2026, compared to $15.4 million, or $1.14 per share, for the second quarter of 2025.

(Press release, OnKure Therapeutics, AUG 4, 2026, View Source [SID1234669685])

On August 4, 2026 Bayer reported half-year financial report 2026.

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(Presentation, Bayer, AUG 4, 2026, View Source [SID1234670289])

On August 4, 2026 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported financial results for the second quarter 2026, and provided a corporate update.

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"Our progress during the quarter has helped position us to fully capitalize on the promise of our platform in oncology and neurology," said Randy Teel, Ph.D., President and Chief Executive Officer at Arvinas. "The approval of VEPPANU, the first ever for a PROTAC degrader, was a significant achievement for the Company, and our subsequent licensing of VEPPANU to Rigel Pharmaceuticals promises to unlock its commercial potential and provide access to patients as efficiently as possible."

"As we move into the second half of the year, enrollment in our ongoing Phase 1 trials is strong and we have important data milestones planned over the next 12 months for ARV-393, ARV-102, and ARV-027," continued Dr. Teel. "In addition, we are initiating our first immuno-oncology Phase 1 trial with ARV-6723 – an HPK1 degrader that has shown meaningful single-agent activity in preclinical models where neither an inhibitor nor an anti-PD1 therapy has shown benefit. Altogether, our pipeline has the potential to address high unmet medical needs and maximize both clinical impact and long-term shareholder value."
Second Quarter 2026 Business Highlights and Recent Developments

Approved Product

VEPPANU (vepdegestrant): Oral PROTAC ER degrader
As part of Arvinas global collaboration with Pfizer, the companies:
•Announced the approval of VEPPANU for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
◦This approval marks the first time the U.S. Food and Drug Administration (FDA) has approved a PROteolysis TArgeting Chimera (PROTAC), a type of heterobifunctional protein degrader therapy.

•Entered into a license agreement with Rigel Pharmaceuticals, Inc. for the exclusive global development, manufacturing, and commercialization rights for VEPPANU.
•Announced that the National Comprehensive Cancer Network (NCCN) added vepdegestrant (VEPPANU) to the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer. Vepdegestrant (VEPPANU) was added as a Category 2A treatment option for patients with hormone receptor (HR)-positive/HER2-negative, ESR1-mutated advanced or metastatic breast cancer after at least one line of endocrine therapy + cyclin-dependent kinase (CDK) 4/6 inhibitor.*

Pipeline

ARV-393: Oral PROTAC BCL6 degrader
•Continued dose escalation in the Phase 1 trial in patients with non-Hodgkin lymphoma (NHL).
▪Preliminary clinical activity has been observed, including responses in B- and T-cell lymphomas, in early cohorts at doses below the predicted effective exposure level.
•Continued enrollment in the Phase 1 combination trial with glofitamab in patients with diffuse large B-cell lymphoma (DLBCL).

ARV-102: Oral PROTAC LRRK2 degrader
•Joined the LRRK2 Investigative Therapeutics Exchange (LITE) program and the Parkinson’s Precision Medicine Initiative (PPMI), both supported by The Michael J. Fox Foundation for Parkinson’s Research (MJFF).

ARV-027: Oral PROTAC polyQ-AR degrader
•Completed the single-ascending dose cohorts of the first-in-human Phase 1 clinical trial in healthy volunteers and initiated enrollment in the multiple dose cohorts in healthy volunteers.

ARV-6723: Oral PROTAC HPK1 degrader
Arvinas’ first immuno-oncology clinical candidate
•Presented preclinical data at the AACR (Free AACR Whitepaper) Annual Meeting demonstrating greater antitumor activity than standard-of-care immune checkpoint inhibitors (ICIs) or an investigational HPK1 inhibitor.
◦Unlike an inhibitor and ICIs, ARV-6723 reversed T-cell exhaustion, reversed the immunosuppressive tumor microenvironment, and boosted innate cell immunity in ICI-(aPD1 and aCTLA4) resistant models.

Novel pan-KRAS degrader
•Presented preclinical data at the AACR (Free AACR Whitepaper) Special Conference in Cancer Research: RAS Oncogenesis and Therapeutics.
◦Robust efficacy observed in CDX models of pancreatic, colorectal, and lung cancer.
◦Greater tumor growth inhibition than a pan-RAS (ON) inhibitor demonstrated in a KRAS G13D model.
◦Enhanced combination efficacy with immune checkpoint blockade compared with a pan-RAS (ON) inhibitor observed in a KRAS G12D syngeneic model.

ARV-806: Novel PROTAC KRAS G12D degrader

•Completed dose escalation enrollment in the Phase 1 clinical trial in patients with solid tumors harboring KRAS G12D mutations.
◦Reiterated plan to share initial data from the Phase 1 monotherapy dose escalation clinical trial in the second half of 2026.
•Announced plans to seek an out-licensing agreement for any additional clinical trials, including dose expansion or combination clinical trials.

Anticipated Upcoming Milestones and Expectations

ARV-393: Oral PROTAC BCL6 degrader
•Share data from early monotherapy cohorts in the ongoing Phase 1 dose escalation clinical trial in patients with relapsed/refractory NHL (ClinicalTrials.gov Identifier: NCT06393738) at a medical congress (2H 2026).
◦Share additional monotherapy data from the ongoing Phase 1 dose escalation trial in B- and T-cell lymphomas (mid-2027).
◦Share data from the combination cohort with glofitamab in patients with DLBCL in the ongoing Phase 1 clinical trial (mid-2027).

ARV-102: Oral PROTAC LRRK2 degrader
•Share additional biomarker data from the Phase 1 clinical trial in patients with Parkinson’s disease at the International Congress on Parkinson’s Disease and Movement Disorders (October 2026).
•Continue discussions with global health authorities on plans to initiate clinical trials in patients with progressive supranuclear palsy (2027).

ARV-027: Oral PROTAC polyQ-AR degrader
•Continue enrollment in the multiple dose cohort of the Phase 1 clinical trial in healthy volunteers and share initial data evaluating androgen receptor (AR)-degradation in muscle (1H 2027).

ARV-6723: Oral PROTAC HPK1 degrader
•Initiate enrollment of the Phase 1 clinical trial in patients with advanced solid tumors (3Q 2026).
Financial Guidance
Based on its current operating plan, Arvinas believes its cash, cash equivalents, and marketable securities as of June 30, 2026, is sufficient to fund planned operating expenses and capital expenditure requirements into the second half of 2028.
Second Quarter 2026 Financial Results
Cash, Cash Equivalents, and Marketable Securities Position: As of June 30, 2026, cash, cash equivalents, and marketable securities were $567.9 million as compared with $685.4 million as of December 31, 2025. The decrease in cash, cash equivalents, and marketable securities of $117.5 million for the six months ended June 30, 2026, was primarily related to cash used in operations of $114.3 million (net of $35.0 million received under the Rigel License Agreement), unrealized losses on marketable securities of $2.0 million, and the purchase of lab equipment and leasehold improvements of $1.5 million.

Research and Development Expenses: Generally Accepted Accounting Principles (GAAP) research and development (R&D) expenses were $52.6 million for the quarter ended June 30, 2026, as compared with $68.6 million for the quarter ended June 30, 2025. The decrease in R&D expenses of $16.0 million for the quarter was primarily due to a decrease in compensation and related personnel expenses of $11.0 million, which are not allocated by program, and a decrease in external expenses of $3.2 million. External expenses include (i) program-specific expenses, which decreased by $0.6 million, primarily driven by a decrease in our vepdegestrant (ARV-471) program of $10.6 million, partially offset by increases in our ARV-806, ARV-027, and ARV-393 programs of $3.9 million, $3.2 million, and $2.3 million, respectively.
Non-GAAP R&D expenses were $51.4 million for the quarter ended June 30, 2026, as compared with $59.5 million for the quarter ended June 30, 2025, excluding $0.3 million and $0.6 million of restructuring expense for the quarters ended June 30, 2026, and 2025, respectively, and $0.9 million and $8.5 million of non-cash stock-based compensation expense for the quarters ended June 30, 2026, and 2025, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

General and Administrative Expenses: GAAP general and administrative (G&A) expenses were $24.0 million for the quarter ended June 30, 2026, as compared with $25.3 million for the quarter ended June 30, 2025. The decrease in G&A expenses of $1.3 million for the quarter was primarily due to decreases in personnel and infrastructure related costs of $3.9 million, and costs related to developing our commercial operations of $1.4 million, partially offset by an increase in professional fees of $4.2 million, inclusive of an increase in the amortization of costs to obtain a contract related to the Pfizer Letter Agreement supplementing and amending the terms of the Original Vepdegestrant (ARV-471) Collaboration Agreement and professional fees related to the Rigel License Agreement.

Non-GAAP G&A expenses were $18.4 million for the quarter ended June 30, 2026, as compared with $18.1 million for the quarter ended June 30, 2025, excluding $1.3 million and $0.4 million of restructuring expenses for the quarters ended June 30, 2026, and 2025, respectively, and $4.3 million and $6.8 million of non-cash stock-based compensation expense for the quarter ended June 30, 2026, and 2025, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

Cost of License Revenue: Cost of license revenue was $9.0 million for the quarter ended June 30, 2026, as compared with zero for the quarter ended June 30, 2025. The increase of $9.0 million was due to expenses under the Amended Yale License Agreement related to the FDA’s approval of VEPPANU and the entry into the Rigel License Agreement.
Revenue: Revenue was $249.7 million for the quarter ended June 30, 2026, as compared with $22.4 million for the quarter ended June 30, 2025. Revenue for the quarter is related to the Original Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer, the research collaboration agreement with Pfizer and the Rigel License Agreement. The increase of $227.3 million was primarily due to $112.6 million of revenue from the Original Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer driven by the recognition of the remaining deferred revenue upon entry into the Rigel License Agreement of $126.4 million, partially offset by a decrease in revenue of $13.8 million for the period prior to the Rigel License Agreement. In addition, we recognized $62.5 million of revenue from the Rigel License Agreement, and $50.0 million of revenue from a development milestone payment in connection with the FDA’s approval of VEPPANU.
Investor Call & Webcast Details
Arvinas will host a conference call and webcast today, August 4, 2026, at 8:00 a.m. ET to review its second quarter 2026 financial results and discuss recent corporate updates. Participants are invited to listen by going to the Events and Presentation section under the Investors page on the Arvinas website at www.arvinas.com. A replay of the webcast will be available on the Arvinas website following the completion of the event and will be archived for up to 30 days.

(Press release, Arvinas, AUG 4, 2026, View Source [SID1234669654])