RegulationPriority Review (United States), Accelerated Approval (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Conditional marketing approval (China)

Structure/Sequence

Sequence Code 13021564

Source: *****

Clinical Trials associated with TARLATAMAB-DLLE

NCT07637513

/ Not yet recruitingPhase 3

Phase III Trial of Consolidation Tarlatamab + Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer (LS-SCLC)

Eligible participants with limited stage-small cell lung cancer (LS-SCLC) will be enrolled after completion of chemotherapy and radiation. Participants will be randomized to either tarlatamab in combination with durvalumab or durvalumab alone as consolidation therapy. Treatment will continue until disease progression, unacceptable side effects or withdrawal of consent.
Tarlatamab is a targeted cancer treatment. It works by acting as a matchmaker between the immune system's T-cells and the cancer cells, forcing them to come together so the T-cells can attack the cancer.
Image testing will be done standardly during treatment. These tests show whether the cancer has progressed and if further treatment may be needed.
The purpose of this trial is to evaluate how well the treatment works (how long before your cancer comes back and how long you live).

Start Date01 Jan 2027

Sponsor / Collaborator

Amgen, Inc.

NCT07699237

/ Not yet recruitingPhase 2IIT

REPLAT- A Multicenter Phase II Trial to Evaluate Rechallenge With Platinum-based Chemotherapy (Carboplatin, Etoposide) for Progression During Tarlatamab Therapy in Relapsed Extensive Disease Small-cell Lung Cancer (SCLC)

The integration of tarlatamab, a bispecific T-cell engager molecule targeting both DLL3 and CD3, into the treatment algorithm for SCLC will substantially improve the prognosis of patients. Nevertheless, disease progression will inevitably occur.
Major challenges for further improving tarlatamab therapy are the molecular understanding of resistance to tarlatamab and the selection of the optimal systemic therapy upon progression. Patients who experience platinum-sensitive progression more than 90 days after first-line chemoimmunotherapy (platinum-free interval (PFI) = day of last administration of platinum-containing chemotherapy until progression) and subsequently progress on tarlatamab therapy may benefit from a platinum-based chemotherapy re-challenge while remaining on tarlatamab treatment. We hypothesize that patients who progress while on tarlatamab may benefit more from the combination of both therapies than from sequential therapy due to synergistic effects. We assume that, besides the cytotoxic effects of platinumbased chemotherapy, additional T-cell modifying effects could support this concept. The disruption of the tumor stroma, which has been described in various chemotherapies, could increase T-cell infiltration and thus have additional immunostimulatory effects (Hoff et al., 2011). The lymphodepletion triggered by chemotherapy and the resulting release of interleukins such as IL-15 could also have an enhancing effect on therapy with bispecific T-cell engagers (Kochenderfer et al., 2017). In addition, it has been shown preclinically that chemotherapeutic agents that have an inhibitory effect on topoisomerase (e.g. doxorubicin) also have a selective inhibitory effect on MDSCs. Here, the administration of the topoisomerase inhibitor etoposide could counteract possible resistance mechanisms (Alizadeh et al., 2014). Different cut-off values for chemotherapy-sensitive progression in small cell lung cancer between 60 - 90 days PFI have been discussed for decades. It has been shown that a platinum re-challenge as a second chemotherapy regimen is superior in a patient population with a PFI greater than 90 days compared to topotecan (Baize et al., 2020). This is expected to apply to approximately 40% of patients receiving standard first-line platinum-based therapy with PD-L1 inhibitors (Torsawa et al., 2023). If tarlatamab is added to first-line therapy in the near future, the proportion of patients with a PFI of more than 90 days could increase further. In the future, platinum-containing chemotherapy could become an increasingly important role as second-line chemotherapy. In parallel with the clinical evaluation of the re-challenge concept, we will conduct an extensive rebiopsy program. This will include a re-biopsy during progression to tarlatamab therapy at screening and a re-biopsy at the time of progression to the study treatment. Whole exome sequencing and transcriptomic analyses of tumor bulks as well as transcriptomic analysis at the single-cell level will be performed to elucidate molecular mechanisms of resistance in the tumor cells and in the tumor microenvironment. Additional immunohistochemical

Start Date01 Nov 2026

Sponsor / Collaborator

Universities of Cologne

NCT07778316

/ RecruitingPhase 3

A Phase 3, Open-Label, Multicenter, Randomized Study of Subcutaneous vs Intravenous Tarlatamab in Participants With Relapsed Extensive-Stage Small Cell Lung Cancer After Platinum-based First-line Chemotherapy (DeLLphi-315)

The primary objective of this study is to demonstrate non-inferiority in pharmacokinetic (PK) parameters of subcutaneous (SC) vs intravenous (IV) tarlatamab administration and to characterize the efficacy, safety, and tolerability of SC tarlatamab in participants with relapsed extensive-stage small-cell lung cancer (ES-SCLC) after platinum-based chemotherapy.

Start Date31 Aug 2026

Sponsor / Collaborator

Amgen, Inc.

100 Clinical Results associated with TARLATAMAB-DLLE

100 Translational Medicine associated with TARLATAMAB-DLLE

100 Patents (Medical) associated with TARLATAMAB-DLLE

136

Literatures (Medical) associated with TARLATAMAB-DLLE

31 Dec 2026·mAbs

Combination therapy with a novel CD2-targeted costimulatory bispecific antibody overcomes limitations of CD3 T cell engager treatment for solid tumors

Article

Author: Dangl, Markus ; Chabot, Sophie ; Niederfellner, Gerhard ; Pasquet, Lise ; Boyance, Aurelien ; Valente, Lou ; Eden, Thomas ; Roure, Virginie ; Shanmuganathan, Sanjith ; Danquah, Welbeck ; Mars, Marion ; Gumz, Ellen ; Gador, Mylène ; Contini, Marion ; Barron, Pauline ; Pichery, Mélanie ; Marchand, Alice ; Czernecki, Lukas

CD3 T cell engagers (TCEs) have transformed hematologic oncology, but dose-liming toxicity and the absence of adequate costimulation have limited TCE success in solid tumors. Consequently, to date, only one classical TCE developed for solid tumors - tarlatamab - has been granted a marketing approval. Here, we report a pioneer combination strategy using a novel CD2-targeted costimulatory bispecific antibody to overcome these limitations. Building on a unique non-blocking CD2 antibody, we developed a HER2×CD2 proof-of-concept bispecific that, combined with an EpCAM×CD3 TCE, provides tumor-dependent costimulation and enhances anti-tumor cytotoxicity mediated by the TCE. We show that HER2×CD2 can be dosed independently to restore optimal anti-tumor cytotoxicity of a sub-efficacious low dose of the EpCAM×CD3 TCE, thus providing a route to avoid TCE-driven toxicity while maintaining efficacy. In a humanized xenograft model, co-treatment with HER2×CD2 achieved complete tumor remission in 8 of 9 mice at a TCE dose that otherwise mediated complete remission in only 1 of 9 mice. We show that HER2×CD2 compensates for the loss of CD58 expression by tumor cells - a well-documented tumor escape mechanism. Notably, unlike CD28-based costimulation, HER2×CD2 effectively also harnessed the anti-tumor cytotoxicity of CD28-negative CD8 T cells - a potent cytotoxic subset prevalent in elderly patients and dominant in solid tumors. Furthermore, HER2×CD2 induced markedly lower cytokine release than a HER2×CD28 bispecific while mediating comparable improvement in anti-tumor cytotoxicity. These findings establish our novel CD2-targeted costimulatory bispecific antibody approach as a promising and potentially safe way to expand and enhance TCE immunotherapy for solid tumors.

01 Dec 2026·CURRENT TREATMENT OPTIONS IN ONCOLOGY

Addressing Unmet Needs in the Management of Small Cell Lung Cancer: Treatment of Brain Metastases, Quality of Life, and the Role of Real-World Evidence

Review

Author: Dai, Yunfei ; Fei, Jing

OPINION STATEMENT:

Small cell lung cancer (SCLC) is a highly aggressive neuroendocrine tumor. Although patient survival has been significantly improved by immune checkpoint inhibitors combined with chemotherapy, three major unmet needs remain in SCLC management. First, while prophylactic cranial irradiation (PCI) can reduce the risk of brain metastases, its neurotoxicity limits its use, particularly in elderly patients or those with neurological deficits. Whole-brain radiotherapy (WBRT) remains the primary approach for brain metastases, and hippocampal-avoidance WBRT (HA-WBRT) combined with neuroprotective agents can significantly reduce cognitive risks. Stereotactic radiosurgery (SRS) has shown survival benefits and less cognitive damage for patients with up to 10 brain metastatic lesions. Emerging therapies, such as antibody-drug conjugates targeting B7-H3/DLL3 (I-Dxd, ZL-1310) and bispecific antibody tarlatamab, have demonstrated intracranial response rates of 62.5%-71%. Regardless of whether the brain metastases had previously undergone radiation therapy, the novel drugs showed consistent activity, indicating promising improvements in the prognosis of brain metastases. Second, the rapid progression and severe treatment-related toxicity of SCLC greatly affect patients' physical and mental well-being. Therefore, quality of life (QoL) should be prioritised. Strategies to improve QoL include early palliative care, proactive symptom management, application of HA-WBRT or SRS to preserve neurocognitive function, and novel agents such as tarlatamab to alleviate symptoms including cough and dyspnoea. Third, real-world evidence (RWE), which complements clinical trial data by reflecting treatment efficacy and safety in routine clinical practice, is gaining increasing recognition but faces challenges due to data heterogeneity, bias, and lack of methodological standardization. Future directions involve developing new drugs with high blood-brain barrier penetration, such as radioligand therapy, conducting prospective studies to optimize HA and SRS applications, establishing high-quality RWE databases to support personalized treatments, exploring molecular subtypes (SCLC-A/N/P/I) and leveraging AI technologies to advance precision radiotherapy. SCLC management needs to be patient-centered, integrating precise treatment of brain metastases, QoL improvement, and the application of RWE to achieve a balance between survival benefits and QoL.

02 Jul 2026·Journal of immunotherapy and precision oncology

Bispecific Antibodies in Solid Tumors: Mechanistic Insights, Clinical Advances, and Future Directions

Review

Author: Mendoza, Megan Macalalad ; Tang, Tin-Yun ; Stephen, Bettzy ; Almosa, Radiya

ABSTRACT:

A rapidly advancing class of engineered immunoglobulins, known as bispecific antibodies (bsAbs), that bind two distinct antigens offers new approaches for tumor targeting and immune modulation. BsAbs function as immune cell engagers, immune checkpoint modulators, or signaling pathway inhibitors. They differ in half-life, stability, and tissue penetration depending on whether they exist in crystallizable fragment (Fc)–based or fragment-based formats. Although bsAbs have shown strong efficacy in hematologic malignancies, their translation to solid tumors has been limited by antigen heterogeneity, off-tumor toxicity, and the immunosuppressive tumor microenvironment. Recent clinical advancements have led to eight approved bsAbs for solid tumors, including amivantamab for EGFR (epidermal growth factor receptor) exon 20 insertion–mutated non-small cell lung cancer (NSCLC), tebentafusp for uveal melanoma, cadonilimab for cervical cancer, tarlatamab for small cell lung cancer, ivonescimab for PD-L1 (programmed death–ligand 1)–positive NSCLC, zanidatamab for HER2 (human epidermal growth factor receptor 2)–amplified biliary tract cancer, zenocutuzumab for NRG1 (neuregulin 1) fusion–positive tumors, and catumaxomab for malignant ascites. These agents have demonstrated durable clinical benefit with manageable safety profiles. However, class-related toxicities such as cytokine release syndrome, immune effector cell–associated neurotoxicity syndrome, and on-target off-tumor effects remain important challenges. Advances in Fc silencing, affinity tuning, and tumor-restricted activation have improved therapeutic selectivity and tolerability. Ongoing innovations include bsAb-drug conjugates, proteolysis-targeting chimeras (PROTACs), and multispecific antibody platforms designed to reprogram the tumor microenvironment and enhance immune infiltration. Biomarker-driven patient selection and rational combination strategies are expected to further improve outcomes. As engineering technologies mature, bsAbs are expected to become integral to precision oncology, expanding safe and effective immunotherapy options for patients with solid tumors. This review aims to provide a comprehensive overview of the mechanisms, clinical applications, challenges, and future directions of bsAbs in solid tumors.

187

News (Medical) associated with TARLATAMAB-DLLE

15 Aug 2026

·www.fiercepharma.com

Jazz to withdraw Zepzelca with FDA in second-line small cell lung cancer

After a yearslong struggle, Jazz Pharmaceuticals has called time on Zepzelca as a second-line treatment for small cell lung cancer. In alignment with the FDA, Jazz plans to ask the agency to remove the second-line SCLC indication from Zepzelca’s label, the company said Monday alongside its second-quarter earnings report. The decision comes after the confirmatory phase 3 Lagoon trial recently failed on its primary endpoint of overall survival. In the study, Zepzelca (lurbinectedin) monotherapy performed even worse than other chemotherapy regimens, while a combination of Zepzelca and irinotecan showed a numerical advantage that didn’t meet statistical significance. The withdrawal does not affect Zepzelca’s first-line maintenance approval as part of a combination with Roche’s Tecentriq for patients with extensive-stage SCLC. Zepzelca’s troubles quickly began to show after its initial FDA go-ahead in second-line SCLC. Just half a year after accelerated approval, the PharmaMar-partnered drug failed in the randomized phase 3 Atlantis trial, which evaluated the chemotherapy in tandem with doxorubicin versus the physician’s choice of chemo in second-line SCLC. Despite the flop, the FDA allowed Zepzelca to remain on the market and, in 2022, rejected a citizen petition calling for its withdrawal. At the time, the agency noted that the Atlantis study used a lower dose of Zepzelca than its approved version, and that an unmet medical need exists in second-line SCLC. Since then, the agency has approved Amgen’s T-cell engager Imdelltra in previously treated SCLC. The Lagoon trial used standard-dose Zepzelca for its single-agent regimen. Commercially, the first-line maintenance nod has given Zepzelca a boost. Sales of the drug in the second quarter increased 42% year over year to $106 million, as Jazz attributed the growth solely to its first-line use. Still, second-line uses make up the majority of Zepzelca’s uptake, with around 30% to 40% of the drug’s U.S. sales coming from the first-line setting, according to Jazz’s chief commercial officer, Sam Pearce, on an investor call Monday. Even before the withdrawal decision, Jazz had already seen a gradual decline in its second-line business due to competition. Now, “we may expect that to accelerate,” Pearce said. Cancer drugmakers have mostly been cooperative in withdrawing their drugs or indications after the FDA ramped up its post-accelerated approval scrutiny in recent years. In 2022, GSK quickly announced plans to remove its antibody-drug conjugate Blenrep merely days after a confirmatory trial flop in third-line multiple myeloma. The British pharma managed to reintroduce the drug as part of a combination last year after new phase 3 wins. Other oncology market withdrawals in recent years as a result of confirmatory trial setbacks include Takeda’s EGFR inhibitor Exkivity in lung cancer, Gilead’s ADC Trodelvy in bladder cancer and Ipsen’s EZH2 inhibitor Tazverik in blood cancer. The content above comes from the network. if any infringement, please contact us to modify.

Accelerated ApprovalClinical ResultADC

06 Aug 2026

·www.biospace.com

Zai Lab Announces Second Quarter 2026 Financial Results and Recent Corporate Updates

The Company advanced multiple global oncology and immunology programs toward key clinical and regulatory milestones, with significant pipeline catalysts expected in the second half of 2026 Global Phase 1 data for zocilurtatug pelitecan (zoci) in combination with a PD-L1 inhibitor in first-line SCLC to be presented at ESMO 2026; planned initiation of a registrational Phase 3 study later this year Registrational Phase 3 DLLEVATE study evaluating zoci in second-line plus SCLC remains on track, with enrollment expected to be completed in the first half of 2027, supporting a potential U.S. accelerated approval submission in 2027 Global Phase 1/1b study of ZL-1503, a potential first-in-class long-acting IL-13/IL-31Rα bispecific antibody for the treatment of atopic dermatitis, continues to advance, with initial first-in-human data expected in the second half of 2026 KarXT successfully launched in mainland China; encouraging early launch trends building momentum ahead of potential NRDL inclusion Total revenues of $106.3 million in the second quarter of 2026; net product revenue grew 11% versus prior quarter driven by stabilization of ZEJULA and double-digit volume growth for VYVGART; commercial business positioned for a return to meaningful growth in 2027 Conference call and webcast today, August 6, 2026, at 8:00 a.m. ET (8:00 p.m. HKT) SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the second quarter of 2026, along with recent product highlights and corporate updates. “Zai Lab is entering an exciting new chapter in our evolution,” said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. “Over the past several years, we have evolved from bringing innovative medicines to patients in China to becoming a global biopharmaceutical company developing our own differentiated medicines for patients around the world. Today, our innovation pipeline is rapidly maturing. We advanced zocilurtatug pelitecan (zoci), our potential best-in-class DLL3 antibody-drug conjugate (ADC), from Investigational New Drug (IND) to global Phase 3 in under two years, and our growing portfolio of internally developed medicines, including ZL-1503, gives us confidence that innovation will increasingly drive Zai Lab's next phase of growth. Meanwhile, we continue to strengthen our commercial business. This quarter, we sharpened our commercial focus, delivered sequential revenue growth, maintained commercial profitability, and laid the foundation for a return to meaningful growth in 2027. Together, these achievements position Zai Lab to create long-term value for patients and shareholders.” “We are excited about the progress across our growing global pipeline, with three registrational studies expected to be underway by year end and the potential for our first U.S. regulatory submission next year,” said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. “Zoci has demonstrated a differentiated profile — strong systemic and intracranial activity with a favorable safety profile — that supports development across multiple treatment settings in small cell lung cancer (SCLC) and extrapulmonary neuroendocrine carcinomas (epNECs). In immunology, ZL-1503 has the potential to address both inflammation and itch through dual inhibition of IL-13 and IL-31. Combined with its extended half-life enabled by YTE modifications, we believe its differentiated pro the potential to address significant unmet needs in one of the largest markets in immunology. We look forward to sharing important clinical updates for both programs in the second half of the year.” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Second Quarter 2026 Financial Results Total revenue was $106.3 million in the second quarter of 2026, compared to $110.0 million for the same period in 2025. Product revenue, net was $105.8 million in the second quarter of 2026, compared to $109.1 million for the same period in 2025. Net product revenue increased 11% versus the prior quarter, driven by stabilization of ZEJULA and continued volume growth for VYVGART. In the second half of the year, we expect to further stabilize product sales while laying the foundation for a return to meaningful growth in 2027. Research and Development (R&D) expenses were $61.8 million in the second quarter of 2026, compared to $50.6 million for the same period in 2025. This increase was primarily due to an increase in licensing fees under our license and collaboration agreements, partially offset by decreased clinical and pre-clinical costs. Selling, General and Administrative (SG&A) expenses were $72.9 million in the second quarter of 2026, compared to $71.0 million for the same period in 2025. SG&A remained relatively flat year over year, reflecting continued efforts to streamline the organization, optimize resource allocation, and enhance operating efficiency as the company advances its next phase of growth. Loss from operations was $76.5 million in the second quarter of 2026, $60.4 million when adjusted to exclude certain non-cash expenses including depreciation, amortization, and share-based compensation. A reconciliation of loss from operations (GAAP) to adjusted loss from operations (non-GAAP) is included at the end of this release. Net loss was $50.8 million in the second quarter of 2026, or a loss per ordinary share attributable to shareholders of $0.05 (or loss per American Depositary Share (ADS) of $0.46), compared to a net loss of $40.7 million for the same period in 2025, or a loss per ordinary share of $0.04 (or loss per ADS of $0.37). The increase in net loss was primarily due to higher licensing fees. Cash and cash equivalents, short-term investments, and current restricted cash totaled $717.5 million as of June 30, 2026, compared to $761.3 million as of March 31, 2026. Recent Pipeline Highlights Below are key product candidate updates since our last earnings release: Oncology Pipeline Zocilurtatug Pelitecan (zoci, DLL3-Targeting ADC) (formerly ZL-1310): In July 2026, Zai Lab received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for zoci for the treatment of neuroendocrine carcinomas (NECs). In June 2026, Zai Lab received ODD from the European Medicines Agency (EMA) for zoci for the treatment of patients with pulmonary NECs. In May 2026, Zai Lab received Fast Track Designation from the FDA for zoci for the treatment of patients with epNECs. This is the second FDA Fast Track Designation for zoci, and we are actively engaging with health authorities on a registrational plan for epNECs. In April 2026, Zai Lab partner Amgen initiated enrollment in the global Phase 1b study (DeLLphi-313) evaluating zoci in combination with tarlatamab with or without anti-PD-L1 in patients with SCLC. TIVDAK (Tisotumab Vedotin, Tissue Factor ADC): In June 2026, China’s National Medical Products Administration (NMPA) approved the Biologics License Application (BLA) for TIVDAK for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is the first ADC approved in China for this indication. Immunology, Neuroscience, and Infectious Disease Pipeline ZL-1503 (IL-13/IL-31Rα): Completed enrollment in the single ascending dose (SAD) portion of the Phase 1/1b study of ZL-1503 in healthy volunteers, with initial PK, PD, safety and immunogenicity data expected in the second half of 2026. Enrollment is ongoing in the multiple ascending dose (MAD) portion of the study in patients with atopic dermatitis. VYVGART (FcRn): In May 2026, the FDA approved the supplemental Biologics License Application (sBLA) submitted by Zai Lab’s partner argenx for VYVGART ® (efgartigimod alfa-fcab) and VYVGART Hytrulo ® (efgartigimod alfa and hyaluronidase-qvfc), expanding the label to include all serotypes of adult patients living with generalized myasthenia gravis (gMG) — anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative. The approval is based on data from the Phase 3 ADAPT SERON study. Zai Lab participated in the ADAPT SERON study in Greater China. Zai Lab is preparing to seek inclusion of VYVGART Hytrulo in China’s National Reimbursement Drug List (NRDL) in 2027. KarXT (xanomeline and trospium chloride) (M1/M4-agonist): In June 2026, Zai Lab commercially launched KarXT in mainland China for the treatment of schizophrenia in adults. KarXT is the first schizophrenia therapy with a novel mechanism of action approved in over 70 years, offering a fundamentally new approach to treating schizophrenia through selective activation of M1 and M4 muscarinic receptors. Zai Lab is preparing to seek inclusion of KarXT in China’s NRDL in 2027. Povetacicept (pove, APRIL/BAFF): In June 2026, Zai Lab partner Vertex announced that the FDA accepted its BLA submission for pove for accelerated approval in adults with immunoglobulin A nephropathy (IgAN), with a PDUFA target action date of November 30, 2026. Zai Lab participated in the global Phase 3 RAINIER study in Greater China. Anticipated Major Milestones in 2026 and the First Half of 2027 Global Pipeline Expected Clinical Developments and Data Readouts Zocilurtatug Pelitecan (zoci, DLL3-Targeting ADC; formerly ZL-1310) First-Line Extensive-Stage Small Cell Lung Cancer (ES-SCLC): Report initial Phase 1 data evaluating zoci in combination with atezolizumab, with or without chemotherapy, at the European Society for Medical Oncology (ESMO) 2026 Congress in October 2026 and, subject to emerging data and regulatory discussions, initiate a registrational Phase 3 study in the second half of 2026. Second-Line Plus ES-SCLC: Complete enrollment in the global pivotal Phase 3 DLLEVATE study in the first half of 2027 followed by a planned interim analysis with the potential to support a BLA submission for accelerated approval. epNECs: Complete enrollment in the Phase 2 expansion portion of the ongoing global Phase 1b/2 study evaluating zoci in patients with selected solid tumors and, subject to regulatory feedback, advance the program into registrational development in the second half of 2026. ZL-1503 (IL-13/IL-31Rα) Report initial first-in-human data from the SAD portion of the global Phase 1/1b study in healthy volunteers, including pharmacokinetics (PK), half-life, pharmacodynamic biomarkers (including pSTAT6), and safety, in the second half of 2026. Continue enrollment in the MAD portion of the Phase 1/1b study in patients with atopic dermatitis. Initial clinical data from the MAD portion expected in the first half of 2027. ZL-6201 (LRRC15 ADC) Provide topline results from the dose-escalation portion of the global Phase 1a/b study evaluating ZL-6201 in patients with sarcoma and selected tumors in the first half of 2027. ZL-1222 (PD-1/IL-12) Submit an IND application in the U.S. and initiate a global Phase 1 study in 2027. ZL-1311 (MUC17/CD3) Submit an IND application in the U.S. by year-end 2026 and initiate a global Phase 1 study in the first half of 2027. Regional Pipeline Upcoming Potential NMPA Acceptance Tumor Treating Fields (TTFields) in locally advanced pancreatic cancer. Expected Clinical Developments and Data Readouts Efgartigimod (FcRn) Myositis: Zai Lab partner argenx to provide topline results from the global Phase 2/3 ALKIVIA study evaluating autoimmune inflammatory myopathies (AIM or myositis) in the third quarter of 2026. Zai Lab participated in the ALKIVIA study in Greater China. Elegrobart (Anti-IGF-1R, subcutaneous) Zai Lab to complete enrollment in the Phase 3 registrational study for the treatment of thyroid eye disease in China in the third quarter of 2026. Zai Lab to provide topline results from the China Phase 3 registrational study in 2027. Conference Call and Webcast Information Zai Lab will host a live conference call and webcast today, August 6, 2026, at 8:00 a.m. ET (8:00 p.m. HKT). Listeners may access the live webcast by visiting the Company’s website at . Participants must register in advance of the conference call. Details are as follows: Registration link for webcast (preferred): Registration link for dial-in: All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering. A replay will be available shortly after the call and can be accessed by visiting the Company’s website. About Zai Lab Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health. For additional information about Zai Lab, please visit or follow us at . Non-GAAP Measures In addition to results presented in accordance with GAAP, we disclose growth rates that have been adjusted to exclude the impact of changes due to the translation of foreign currencies into U.S. dollars. We have also presented a measure of adjusted loss from operations that adjusts GAAP loss from operations to exclude the impact of certain non-cash expenses including depreciation, amortization, and share-based compensation, which we refer to as “profitability.” These adjusted growth rates and adjusted loss from operations are non-GAAP measures. We believe that these non-GAAP measures are important for an understanding of the performance of our business operations and financial results and provide investors with an additional perspective on operational trends and greater transparency into our historical and projected operating performance. Although we believe the non-GAAP financial measures enhance investors’ understanding of our business and performance, these non-GAAP financial measures should not be considered an exclusive alternative to accompanying GAAP financial measures. Zai Lab Forward-Looking Statements This press release contains certain forward-looking statements, including statements relating to our strategy and plans; potential of and expectations for our business, commercial products, and pipeline programs; our goals, objectives, and priorities and our expectations under our growth strategy (including our expectations regarding our commercial products and launches, clinical stage products, revenue growth, profitability, and cash flow); clinical development programs and related clinical trials; clinical trial data, data readouts, and presentations; risks and uncertainties associated with drug development and commercialization; regulatory discussions, submissions, filings, and approvals and the timing thereof; the potential benefits, safety, and efficacy of our products and product candidates and those of our collaboration partners; the anticipated benefits and potential of investments, collaborations, and business development activities; our profitability and timeline to profitability; our future financial and operating results; and financial guidance, including with respect to our capital allocation and investment strategy and our expected path to profitability. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “poised,” “positioned,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products; (2) our ability to obtain funding for our operations and business initiatives; (3) the results of our clinical and pre-clinical development of our product candidates; (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates; (5) risks related to doing business in China; and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at and on the SEC’s website at . Zai Lab Limited Unaudited Condensed Consolidated Balance Sheets (in thousands of U.S. dollars ($), except for number of shares and per share data) June 30, 2026 December 31, 2025 Assets Current assets Cash and cash equivalents 607,522 679,573 Restricted cash, current 100,000 100,000 Short-term investments 10,000 10,000 Accounts receivable (net of allowance for credit losses of $20 and $31 as of June 30, 2026 and December 31, 2025, respectively) 69,595 106,116 Notes receivable 3,395 12,169 Inventories, net 90,890 74,745 Prepayments and other current assets 32,635 36,683 Total current assets 914,037 1,019,286 Restricted cash, non-current 1,118 1,116 Property and equipment, net 46,431 47,389 Operating lease right-of-use assets 16,159 19,152 Land use rights, net 2,883 2,853 Intangible assets, net 85,774 76,144 Deferred tax assets 4,848 3,390 Other non-current assets 3,543 3,054 Total assets 1,074,793 1,172,384 Liabilities and shareholders’ equity Current liabilities Accounts payable 136,692 141,608 Current operating lease liabilities 5,025 6,344 Short-term debt 238,104 204,530 Other current liabilities 48,763 63,684 Total current liabilities 428,584 416,166 Deferred income 27,500 27,333 Non-current operating lease liabilities 11,447 13,385 Other non-current liabilities 225 — Total liabilities 467,756 456,884 Commitments and contingencies Shareholders’ equity Ordinary shares (par value of $0.000006 per share; 5,000,000,000 shares authorized; 1,132,222,310 and 1,113,822,550 shares issued as of June 30, 2026 and December 31, 2025, respectively; 1,122,445,390 and 1,106,389,340 shares outstanding as of June 30, 2026 and December 31, 2025, respectively) 7 7 Additional paid-in capital 3,370,798 3,343,469 Accumulated deficit (2,730,461 ) (2,628,620 ) Accumulated other comprehensive income 214 29,697 Treasury Stock (at cost, 9,776,920 and 7,433,210 shares as of June 30, 2026 and December 31, 2025, respectively) (33,521 ) (29,053 ) Total shareholders’ equity 607,037 715,500 Total liabilities and shareholders’ equity 1,074,793 1,172,384 Zai Lab Limited Unaudited Condensed Consolidated Statements of Operations (in thousands of $, except for number of shares and per share data) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Revenues Product revenue, net 105,751 109,085 201,307 214,735 Collaboration revenue 560 892 4,615 1,729 Total revenues 106,311 109,977 205,922 216,464 Expenses Cost of product revenue (48,162 ) (43,003 ) (86,477 ) (81,455 ) Cost of collaboration revenue — (217 ) (20 ) (412 ) Research and development (61,766 ) (50,614 ) (127,357 ) (111,343 ) Selling, general, and administrative (72,872 ) (71,038 ) (137,942 ) (134,460 ) Loss from operations (76,489 ) (54,895 ) (145,874 ) (111,206 ) Interest income 5,879 8,843 12,326 17,449 Interest expenses (1,587 ) (1,262 ) (3,224 ) (2,449 ) Foreign currency gains 15,065 2,837 29,902 3,488 Other income, net 5,285 3,750 5,447 3,553 Loss before income tax (51,847 ) (40,727 ) (101,423 ) (89,165 ) Income tax benefit (expense) 1,022 — (418 ) — Net loss (50,825 ) (40,727 ) (101,841 ) (89,165 ) Loss per share - basic and diluted (0.05 ) (0.04 ) (0.09 ) (0.08 ) Weighted-average shares used in calculating net loss per ordinary share - basic and diluted 1,116,973,380 1,091,933,150 1,112,208,460 1,086,413,130 Zai Lab Limited Unaudited Condensed Consolidated Statements of Comprehensive Loss (in thousands of $) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Net loss (50,825 ) (40,727 ) (101,841 ) (89,165 ) Other comprehensive loss, net of tax of nil: Foreign currency translation adjustments (14,891 ) (2,955 ) (29,483 ) (4,167 ) Comprehensive loss (65,716 ) (43,682 ) (131,324 ) (93,332 ) Zai Lab Limited Non-GAAP Measures (unaudited) ($ in thousands) Growth on a Constant Exchange Rate (CER) Basis Three Months Ended June 30, Year over Year % Growth Six Months Ended June 30, Year over Year % Growth 2026 2025 As reported At CER* 2026 2025 As reported At CER* Product revenue, net 105,751 109,085 (3 )% (7 )% 201,307 214,735 (6 )% (10 )% Loss from operations (76,489 ) (54,895 ) 39 % 36 % (145,874 ) (111,206 ) 31 % 29 % * The growth rates at CER were calculated assuming the same foreign currency exchange rates were in effect for the current and prior year period Reconciliation of Loss from Operations (GAAP) to Adjusted Loss from Operations (Non-GAAP) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 GAAP loss from operations (76,489 ) (54,895 ) (145,874 ) (111,206 ) Plus: Depreciation and amortization expenses 4,173 3,735 8,117 7,193 Plus: Share-based compensation 11,941 16,973 25,465 32,773 Adjusted loss from operations (60,375 ) (34,187 ) (112,292 ) (71,240 ) Contacts Investor Relations: Christine Chiou / Cyan Liu +1 (917) 886-6929 / +86 195 3130 8895 christine.chiou1@zailaboratory.com / cyan.liu@zailaboratory.com Media: Shaun Maccoun / Xiaoyu Chen +1 (415) 317-7255 / +86 185 0015 5011 shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com

Phase 1Drug ApprovalFast TrackAccelerated ApprovalFinancial Statement

04 Aug 2026

·www.prnewswire.com

AMGEN REPORTS SECOND QUARTER 2026 FINANCIAL RESULTS

THOUSAND OAKS, Calif., Aug. 4, 2026 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced financial results for the second quarter of 2026. "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. References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis," and "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion. Product Sales Performance General Medicine Repatha® (evolocumab) sales increased 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 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. 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. 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. 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. EYLEA HD is a registered trademark of Regeneron Pharmaceuticals, Inc. Non-GAAP Financial Measures In this news release, management has presented its operating results for the second quarters of 2026 and 2025, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2026 EPS and tax guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, restructuring and certain other items from the related GAAP financial measures. Management has presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the second quarters of 2026 and 2025. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP. The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor's overall understanding of the financial performance and prospects for the future of the Company's normal and recurring business activities by facilitating comparisons of results of normal and recurring business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company's liquidity. The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. About Amgen Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world's toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines. More than 45 years ago, Amgen helped establish the biotechnology industry at its U.S. headquarters in Thousand Oaks, California, and it remains at the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases and obesity and obesity-related conditions. Amgen has been consistently recognized for innovation and workplace culture, including honors from Fast Company and Forbes. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization. For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, YouTube, Facebook, TikTok and Threads. Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeOne Medicines Ltd.), the performance of Otezla® (apremilast), our acquisitions of ChemoCentryx, Inc., Dark Blue Therapeutics, Ltd. or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions, including those resulting from geopolitical relations and government actions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful, and may result in unanticipated costs, delays or failures to realize the benefits of the transactions. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our sustainability objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. CONTACT: Amgen, Thousand Oaks Elissa Snook, 609-251-1407 (media) Annik Allen, 917-288-9136 (media) Casey Capparelli, 805-447-1746 (investors) Our GAAP diluted EPS guidance does not include the effect of GAAP adjustments triggered by events that may occur subsequent to this press release such as acquisitions, asset impairments, litigation, changes in fair value of our contingent consideration obligations and changes in fair value of our equity investments. SOURCE Amgen 21% more press release views with Request a Demo

Phase 3Clinical ResultDrug ApprovalPhase 2Acquisition

100 Deals associated with TARLATAMAB-DLLE

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Small Cell Lung Cancer	Canada	Amgen, Inc.	01 Sep 2024
Extensive stage Small Cell Lung Cancer	United States	Amgen, Inc.	16 May 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent Lung Small Cell Carcinoma	Phase 3	United States	Amgen, Inc.	31 Aug 2026
Recurrent Lung Small Cell Carcinoma	Phase 3	China	Amgen, Inc.	31 Aug 2026
Small cell lung cancer limited stage	Phase 3	United States	BeOne Medicines (Beijing) Co., Ltd.	23 Jan 2024
Small cell lung cancer limited stage	Phase 3	United States	Amgen, Inc.	23 Jan 2024
Small cell lung cancer limited stage	Phase 3	Japan	Amgen, Inc.	23 Jan 2024
Small cell lung cancer limited stage	Phase 3	Japan	BeOne Medicines (Beijing) Co., Ltd.	23 Jan 2024
Small cell lung cancer limited stage	Phase 3	Argentina	Amgen, Inc.	23 Jan 2024
Small cell lung cancer limited stage	Phase 3	Argentina	BeOne Medicines (Beijing) Co., Ltd.	23 Jan 2024
Small cell lung cancer limited stage	Phase 3	Australia	BeOne Medicines (Beijing) Co., Ltd.	23 Jan 2024
Small cell lung cancer limited stage	Phase 3	Australia	Amgen, Inc.	23 Jan 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2026	Not Applicable	Acute Lymphoblastic Leukemia \| Small Cell Carcinoma \| B-Cell Lymphoma ... View more	3,642	bispecific T-cell engager therapy	gipkffloce(hyxqevitfg) = ziglbdrfrq rzgwtdrged (txddtitdzs ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Small Cell Lung Cancer \| Neuroendocrine Carcinoma DLL3	24	Tarlatamab	mrkpooonwd(ejpftejjjx) = xrfcolbciz mvxjxgystq (webzamgvcp ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Small Cell Lung Cancer \| Neuroendocrine Carcinoma DLL3	24	Tarlatamab (patients with brain metastases)	mrkpooonwd(ejpftejjjx) = azxrcwkfdr mvxjxgystq (webzamgvcp ) View more	Positive	29 May 2026
NCT07111507 (TIDAL, ASCO2026)	Phase 2	Metastatic Prostate Carcinoma DLL3-positive	32	Tarlatamab	lvxvnwgfnj(iyujfzjslb) = cidgarxcfy yfffkyyhyh (onhqiddofa, 20.4 - NR)	Positive	29 May 2026
ASCO2026	Not Applicable	Extensive stage Small Cell Lung Cancer	682	Tarlatamab (ES-SCLC)	yijxlqmrch(ydkwuncgmb) = cdpkhanajj ftxcjslwru (hczfdeawey ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Islet Cell Carcinoma DLL3	54	platinum-based chemotherapy + Atezolizumab	mdhrlmtafz(pachezrdbf) = fsxakzozxe gyirbiwtnn (cfjcgzvdfa ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Islet Cell Carcinoma DLL3	54	platinum-based chemotherapy + Durvalumab	mdhrlmtafz(pachezrdbf) = aavinfnjwm gyirbiwtnn (cfjcgzvdfa ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Extensive stage Small Cell Lung Cancer Second line	20	Tarlatamab	ogzywpouxz(yhfdaemvbv) = jyunfhwlrl lgcsbbthib (lpqybncmlr ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Small Cell Carcinoma	37	Tarlatamab (Small Cell Carcinoma)	emydmfaedy(ypzhscaies) = seen in 54.1% (20/37) and 18.2% (6/33) of patients on day 1 and day 8, respectively. bjzbatgvzq (pudmudxlmm ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Small Cell Carcinoma	37	Tarlatamab (transformed and non-lung primary)		Positive	29 May 2026
ASCO2026	Not Applicable	Extensive stage Small Cell Lung Cancer	115	Tarlatamab	gmstbrtdjr(ulclicpeuq) = yywrrwzrdh ohmdnudxyb (mmodpzvavm ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Extensive stage Small Cell Lung Cancer	52	Tarlatamab	bhxrpcyfjs(gewzfdtmbq) = pezxpoolcv lbpifnsyld (xvonjqqdpv ) View more	Negative	29 May 2026
DeLLphi 304 (ASCO2026)	Phase 3	Recurrent Lung Small Cell Carcinoma Second line DLL3	266	Tarlatamab	kimdwizqxn(ppyjvysyer) = cgzsrvbzkm ckkfcnysfe (xdpfgehpdt ) View more	Positive	29 May 2026
DeLLphi 304 (ASCO2026)	Phase 3	Recurrent Lung Small Cell Carcinoma Second line DLL3	266	Lurbinectedin	qnsxiufzrl(fntcmmbbyx) = vyxbbsxqnx hggngmlxdy (ekfdzdhqvm ) View more	Positive	29 May 2026

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