Request Demo

Last update 27 Feb 2026

Lurbinectedin

Last update 27 Feb 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Lurbinectedin (USAN/INN), Lurbinectedina, Tryptamicidin

+ [9]

Target

DNA

Action

inhibitors

Mechanism

DNA inhibitors(DNA inhibitors)

Therapeutic Areas

NeoplasmsRespiratory DiseasesOther Diseases+ [6]

Active Indication

Extensive stage Small Cell Lung CancerSmall Cell Lung CancerLeiomyosarcoma+ [22]

Inactive Indication

acute leukemiaAdvanced cancerAdvanced Neuroendocrine Carcinoma+ [22]

Originator Organization

Active Organization

+ [10]

Inactive Organization-

License Organization

Megapharm Ltd.

Luye Pharma Group Ltd.

Chugai Pharmaceutical Co., Ltd.

+ [11]

Drug Highest PhaseApproved

First Approval Date

United States (15 Jun 2020),

Small Cell Lung Cancer

RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea), Orphan Drug (Australia), Overseas New Drugs Urgently Needed in Clinical Settings (China), Conditional marketing approval (Israel), Emergency Use Authorization (China), Priority Review (United States), Conditional marketing approval (China), Priority Review (China), Orphan Drug (Switzerland)

Structure/Sequence

Molecular FormulaC41H44N4O10S

InChIKeyYDDMIZRDDREKEP-HWTBNCOESA-N

CAS Registry497871-47-3

Clinical Trials associated with Lurbinectedin

NCT07153055

/ Not yet recruitingPhase 1/2IIT

Phase I/II Trial of Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer

This open-label, Phase I/II trial is studying the safety and effectiveness of an experimental drug combination, lurbinectedin with osimertinib, against a rare type of cancer known as transformed small cell lung cancer (SCLC).

Start Date01 May 2026

Sponsor / Collaborator

Indiana University

[+1]

ChiCTR2600116747

/ Not yet recruitingPhase 2IIT

A Prospective, Multicenter, Phase II Clinical Study of Lucansartuzumab Combined with Tislelizumab as Neoadjuvant Therapy for Resectable Stage II–IIIB NSCLC

Start Date28 Jan 2026

Sponsor / Collaborator

Shanghai Chest Hospital

NCT07141771

/ Not yet recruitingPhase 1/2IIT

An Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular Typing

Small-cell lung cancer (SCLC) has a high degree of malignancy and extremely poor prognosis, slow progress in the treatment of ES-SCLC, and a more ideal posterior therapy needs to be explored. This is an I / II, phase umbrella study to explore afterline treatment options following progression of frontline platinum-containing therapy for small cell lung cancer.
This study includes 2 parts:
Part 1 will enroll patients with end of first-line platinum-containing therapy and progression interval of less than 180 days or more of second-line therapy (no first-line relapse time required).
Part 2 will enroll patients with end of first-line platinum-containing therapy greater than 180 days.
Based on the optimal selection of patients with recurrent broad-stage small cell lung cancer with different molecular and clinical characteristics, we further explored different treatment modes suitable for different populations through umbrella cohort studies.

Start Date31 Dec 2025

Sponsor / Collaborator

Cancer Hospital Chinese Academy of Medical Sciences

100 Clinical Results associated with Lurbinectedin

100 Translational Medicine associated with Lurbinectedin

100 Patents (Medical) associated with Lurbinectedin

173

Literatures (Medical) associated with Lurbinectedin

01 Jan 2026·ADVANCES IN THERAPY

Real-World Treatment Patterns and Clinical Outcomes in Patients With Extensive-Stage Small Cell Lung Cancer Treated With First-Line Platinum-Based Chemotherapy and ≥ 2 Subsequent Lines of Therapy in the United States

Article

Author: Ahmed, Sajid ; Sankar, Kamya ; Herrmann, Tara ; Gorsh, Boris ; Tang, Mei ; Eberl, Marian ; Unni, Sudhir ; Le, Hoa ; Coerts, Friso

INTRODUCTION:

Although patients with extensive-stage small cell lung cancer (ES-SCLC) typically respond well to first-line (1L) platinum-based chemotherapy (PBC)-containing regimens, disease recurrence is common, and survival is short. Treatment options beyond 1L are limited, leaving an urgent need for more effective treatment options. Understanding patient characteristics, treatment patterns, and clinical outcomes in this setting may inform clinical development of novel therapies for ES-SCLC.

METHODS:

This study is a retrospective, observational analysis of real-world data from a US nationwide electronic health record-derived de-identified database. Patients with ES-SCLC who received 1L PBC between January 1, 2018, and June 30, 2023, were included. Treatment patterns were analyzed in all patients, and clinical outcomes from third-line (3L) therapy initiation were assessed in those who also received 3L treatment. The study period (January 1, 2018, through December 31, 2023) allowed for ≥ 6 months' potential follow-up.

RESULTS:

Of 2573 patients (50.5% female; 49.5% male) included in the overall population, 992 (38.6%), 344 (13.4%), and 114 (4.4%) received ≥ 1, ≥ 2, and ≥ 3 subsequent treatment lines, respectively. Treatment patterns beyond 1L were fragmented: the most common second-line treatments were lurbinectedin-containing regimens (26.5%), and in 3L were lurbinectedin-containing regimens (21.8%) or topoisomerase inhibitors (21.8%). From 3L therapy initiation, median real-world overall survival (rwOS) was 4.53 months (95% confidence interval [CI] 3.71-5.39), median real-world time to treatment discontinuation or death (rwTTD/D) was 2.56 months (95% CI, 2.27-2.79), median real-world time to next treatment or death (rwTTNT/D) was 2.92 months (95% CI, 2.69-3.12), and real-world response rate among 77 evaluable patients was 11.7% (95% CI, 5.5-21.0).

CONCLUSIONS:

This study demonstrated the heterogeneity of treatments after 1L PBC-containing therapy for patients with ES-SCLC, with no clear standard of care identified. In 3L, rwTTD/D, rwTTNT/D, and rwOS were short, demonstrating the substantial unmet need for novel treatments in this setting.

01 Jan 2026·CANCER LETTERS

Drug screening reveals differential drug response in primary and metastatic clear cell sarcoma

Article

Author: Vejzovic, Djenana ; Holzer, Viktoria ; Prietl, Barbara ; Ritter, Gerald ; Stanzer, Stefanie ; Lyssy, Freya ; Guillén-Navaro, Maria Jose ; Barones, Lisa ; El-Heliebi, Amin ; Rinner, Beate ; Gauster, Martin ; Wagner, Karin ; Liegl-Atzwanger, Bernadette ; Brčić, Iva ; Fechter, Karoline ; Schweintzger, Nina A ; Avilés, Pablo M ; Karner, Christina ; Szkandera, Joanna ; Lohberger, Birgit

Clear Cell Sarcoma (CCS) are ultra-rare fusion-translocated soft-tissue tumours occurring mainly in young adults with poor prognosis. Their aggressiveness and resistance to conventional chemotherapy, especially in a metastatic setting, characterize these tumours. A functional drug screen consisting of 80 drugs was performed on patient-derived CCS cell lines. Top candidates were validated in 3D cell culture and in vivo models, allowing comparison of drug responses among CCS cell lines, including one matched pair (MUG Lucifer cell lines) representing primary and metastatic disease from the same patient. Underlying mechanisms were evaluated with RNA Seq, fluorescence/luminescence based assays, Western blot and IHC. In vitro experiments in CCS spheroids highlighted the transcription inhibitor lurbinectedin to be the best overall candidate which was further confirmed in mouse xenografts, albeit to a lesser extent than observed in vitro, especially in the metastatic CCS model. Transcriptional and functional analyses revealed heterogeneous drug responses and differences in cell death mechanisms across CCS lines, reflecting patient-specific variability. Furthermore, we explored combination treatment of lurbinectedin with selinexor. Synergistic effects were confirmed in a novel autologous co-culture model incorporating cancer-associated fibroblasts, providing a more physiologically relevant system for drug testing. This study identified promising therapeutic avenues by highlighting key vulnerabilities in CCS, considering both inter-tumour heterogeneity, tumour plasticity and the stromal influence on drug response.

31 Dec 2025·OncoImmunology

FDA approves lurbinectedin in combination with atezolizumab for extensive-stage small cell lung cancer

Article

Author: Kepp, Oliver ; Kroemer, Guido

The recent FDA approval of lurbinectedin plus atezolizumab for advanced small cell lung cancer underscores the promise of combining immunogenic cell death (ICD) inducers with PD-1/PD-L1 blockade. This synergistic strategy induces durable responses in refractory tumors and may extend immunotherapy benefits across diverse malignancies through rational ICD-checkpoint inhibitor combinations.

173

News (Medical) associated with Lurbinectedin

26 Feb 2026

·www.biospace.com

Zai Lab Announces Fourth Quarter and Full Year 2025 Financial Results and Recent Corporate Updates

– Total revenues grew 17% y-o-y to $127.6 million for the fourth quarter of 2025 and 15% y-o-y to $460.2 million for the full-year 2025 – Zocilurtatug pelitecan (zoci) on track to become Zai Lab’s first global oncology launch, with three registration-enabling studies across 2L+ SCLC, 1L SCLC, and extrapulmonary NECs by the end of 2026 – Advancing a differentiated global pipeline, including ZL-1503 (IL-13/IL-31Rα), ZL-6201 (LRRC15 ADC), ZL-1222 (PD-1/IL-12) and ZL-1311 (MUC17/CD3 TCE) – Key regional programs continue to advance, with KarXT approved in China and commercial launch preparations underway; pivotal data readouts for povetacicept in IgAN and elegrobart in TED expected in 2026 Conference call and webcast today, February 26, 2026, at 8:00 a.m. ET (9:00 p.m. HKT) SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the fourth quarter and full-year 2025, along with recent product highlights and corporate updates. “2025 was a year of disciplined execution across both engines of our business with significant advancement across our global innovation pipeline and steady progress in our commercial business,” said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. “We accelerated multiple global programs, including the rapid progression of zoci into pivotal development, enabled by our integrated U.S./China infrastructure which allows us to operate with speed and capital efficiency. In 2026, our focus is on executing against important catalysts – advancing late-stage immunology and oncology programs while preparing for the next wave of commercial growth. Together, these efforts mark an important step in Zai Lab’s continued evolution into a global biopharma leader.” “KarXT represents a significant new growth driver for Zai Lab, and its recent inclusion in a national expert consensus underscores the growing recognition of its novel mechanism and potential to meaningfully impact patients living with schizophrenia,” said Josh Smiley, President and Chief Operating Officer of Zai Lab. “We are strengthening the VYVGART franchise by expanding hospital coverage and supporting longer treatment persistence. Concurrently, we are preparing for the potential approvals of TIVDAK, which would further strengthen our women’s health franchise, and TTFields in pancreatic cancer. Looking beyond 2026, the combination of new launches, potential label expansions and advancing global programs, positions us for multi-year growth and continued financial improvement.” Fourth Quarter and Full-Year 2025 Financial Results Total revenue was $127.6 million in the fourth quarter of 2025 and $460.2 million for the full-year 2025. Product revenue, net was $127.1 million in the fourth quarter of 2025, compared to $108.5 million for the same period in 2024, representing 17% y-o-y growth and 16% at constant exchange rate (CER); and was $457.2 million in full-year 2025, compared to $397.6 million for the same period in 2024, representing 15% y-o-y growth and 16% y-o-y growth at CER. This increase was primarily due to higher revenue for XACDURO and NUZYRA. – ZEJULA was $56.0 million in the fourth quarter of 2025, an increase of 16% y-o-y from $48.4 million; and was $189.0 million in full-year 2025, compared to $187.1 million for the same period in 2024. ZEJULA continued to be the leading PARP inhibitor in hospital sales for ovarian cancer despite evolving competitive dynamics within the PARPi class in mainland China. – VYVGART and VYVGART Hytrulo were $21.9 million in the fourth quarter of 2025 which includes a $5.6 million rebate for VYVGART related to the National Reimbursement Drug List (NRDL) renewal, compared to $30.0 million for the same period in 2024; and was $94.2 million in full-year 2025, compared to $93.6 million for the same period in 2024. – XACDURO, which was launched in the fourth quarter of 2024, was $10.7 million in the fourth quarter of 2025, an increase of 225% y-o-y from $3.3 million; and was $22.9 million in full-year 2025, an increase of 593% y-o-y from $3.3 million. Growth was driven by strong patient demand and expanding hospital adoption but was partially constrained by supply limitations during the year. – NUZYRA was $16.0 million in the fourth quarter of 2025, an increase of 45% y-o-y from $11.0 million; and was $60.8 million in full-year 2025, an increase of 41% y-o-y from $43.2 million. This growth was supported by increased market coverage and penetration. Research and Development (R&D) expenses were $61.6 million in the fourth quarter of 2025, compared to $52.3 million for the same period in 2024, and $220.9 million for full-year 2025, compared to $234.5 million for the same period in 2024. The fourth-quarter increase resulted from progress in clinical trials. The full year decline was primarily driven by lower personnel compensation due to strategic resource optimization. Selling, General and Administrative (SG&A) expenses were $73.0 million in the fourth quarter of 2025, compared to $82.6 million for the same period in 2024, and $277.6 million for full-year 2025, compared to $298.7 million for the same period in 2024. The decrease was primarily due to a reduction in general and administrative expenses due to strategic resource optimization. Loss from operations was $69.4 million and $229.4 million in the fourth quarter of 2025 and full-year 2025, respectively, and $49.6 million and $148.8 million, respectively, when adjusted to exclude non-cash expenses, including depreciation, amortization, and share-based compensation. Loss from operations was $67.9 million and $282.1 million in the fourth quarter of 2024 and full-year 2024, respectively. 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 $50.4 million in the fourth quarter of 2025, or a loss per ordinary share attributable to common stockholders of $0.05 (or loss per American Deposit Share (ADS) of $0.46), compared to a net loss of $81.7 million for the same period in 2024 or a loss per ordinary share of $0.08 (or loss per ADS of $0.80). The net loss was $175.5 million for full-year 2025, or a loss per ordinary share attributable to common stockholders of $0.16 (or loss per ADS of $1.60), compared to a net loss of $257.1 million for full-year 2024, or a loss per ordinary share of $0.26 (or loss per ADS of $2.60). These decreases in net loss were primarily due to product revenue growing faster than net operating expenses and shift from foreign currency losses to foreign currency gains, offset by decreased interest income. Cash and cash equivalents, short-term investments and current restricted cash totaled $789.6 million as of December 31, 2025, compared to $879.7 million as of December 31, 2024. 2026 Strategic Priorities Zai Lab will focus on the following strategic priorities in 2026 to drive near-term performance and long-term global value creation: Advancing Differentiated Global Programs Across Oncology and Immunology Zocilurtatug pelitecan (zoci) (DLL3-targeting ADC): Advance three registration-enabling studies across 2L+ SCLC, 1L SCLC, and other neuroendocrine carcinomas (NECs) by the end of 2026. Three data readouts expected in 2026, including: – 2L+ SCLC: Updated global Phase 1 data highlighting intracranial response in patients with brain metastases. – 1L SCLC: Data from an ongoing Phase 1 combination study evaluating doublet and triplet regimens with a PD-L1 inhibitor, with or without chemotherapy; initiation of global Phase 1 study with novel combination. – Extrapulmonary NECs: Data from the Phase 1b portion of the ongoing global Phase 1b/2 study. ZL-1503 (IL-13/IL-31Rα bispecific antibody): First-in-Human (FIH) data from the ongoing global Phase 1/1b study expected in the second half of 2026, paving the way for Phase 2 development in atopic dermatitis (AD). ZL-6201 (LRRC15-targeting ADC): Global Phase 1 ongoing. ZL-1222 (PD-1/IL-12 immunocytokine): Investigational New Drug (IND)-enabling studies expected to be completed in 2026. ZL-1311 (T-cell engager (TCE) targeting MUC17): IND submission expected by year end. Zai Lab is building capabilities in TCEs and exploring additional immunocytokines beyond IL-12, with further details to be provided throughout the year. Commercial Execution and Key Near-Term Regional Launches to Drive Steady Growth VYVGART and VYVGART Hytrulo: Continue to increase patient utilization and duration of treatment in generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). KarXT: Planned commercial launch in the first half of 2026, supported by a targeted commercial strategy, physician education, real-world evidence generation, and preparation for potential NRDL inclusion in 2027. Povetacicept and elegrobart: Both have pivotal readouts in 2026 and are expected to further strengthen regional revenue growth in the near term. Key Corporate Updates Below are key corporate updates since our last earnings release: Business Development: – We obtained the exclusive worldwide rights to develop and commercialize ZL‑1311, a next‑generation TCE targeting MUC17, which is a promising and druggable antigen overexpressed in up to ~50% of gastric and gastroesophageal junction cancers. This program represents Zai Lab’s first globally owned TCE and strategically expands our immuno‑oncology portfolio while leveraging our established expertise in GI cancers. ZL‑1311 is expected to enter global clinical development this year. – We formed a strategic collaboration with SciClone Pharmaceuticals (SciClone) for AUGTYRO™ (repotrectinib), which was approved in mainland China for ROS1‑positive non‑small‑cell lung cancer in May 2024 and for NTRK‑positive solid tumors in January 2026. Through this collaboration, Zai Lab will leverage SciClone’s commercialization infrastructure to broaden access and accelerate the commercial rollout of this innovative therapy for patients in need across mainland China. NRDL Updates: In December 2025, Zai Lab announced the successful renewals of VYVGART (efgartigimod alfa injection) for gMG patients who are anti-acetylcholine receptor (AChR) antibody positive, NUZYRA (omadacycline) for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) and ZEJULA (niraparib) for platinum-sensitive, first-line and recurrent ovarian cancer patients in China’s NRDL. Recent Pipeline Highlights Below are key product candidate updates since our last earnings release: Oncology Pipeline Zocilurtatug Pelitecan (zoci, DLL3 ADC): – Second-Line+ ES-SCLC: The global Phase 3 study evaluating the efficacy and safety of zoci versus investigator’s choice therapy (topotecan, lurbinectedin, or amrubicin) in patients with relapsed SCLC is ongoing. This pivotal study plans to enroll approximately 480 patients in 2L SCLC or 3L post‑tarlatamab SCLC, with the majority of enrollment anticipated to be completed this year. – Extrapulmonary NECs : In January 2026, Zai Lab dosed the first patient in the global Phase 2 portion of its ongoing Phase 1b/2 study in NECs. Zai Lab plans to present an initial data readout from the Phase 1b portion in the first half of 2026, complete enrollment for the Phase 2 portion, and advance the program into the registrational stage within the year. ZL-6201 (LRRC15 ADC): In January 2026, the FDA cleared the IND application for a global Phase 1 study in patients with sarcoma and potentially other LRRC15-positive solid tumors. The global Phase 1 study has been initiated. Tumor Treating Fields (TTFields): In February 2026, the FDA approved Optune Pax ® for the treatment of adult patients with locally advanced pancreatic cancer concomitant with gemcitabine and nab-paclitaxel. It is the first treatment approved by the FDA for locally advanced pancreatic cancer in nearly 30 years. China’s NMPA granted Innovative Medical Device Designation for the treatment of pancreatic cancer in August 2025. AUGTYRO™ (repotrectinib, ROS1/TRK): In December 2025, China’s NMPA approved the supplemental New Drug Application (sNDA) for AUGTYRO™ (repotrectinib) for the treatment of adult patients with solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Immunology, Neuroscience, and Infectious Disease Pipeline ZL-1503 (IL-13/IL-31Rα): In December 2025, Zai Lab dosed the first participant in a global Phase 1/1b study evaluating the safety, tolerability, pharmacokinetics, and efficacy of ZL-1503 for the treatment of AD. Zai Lab expects to report the first-in-human data from the global Phase 1 portion in the second half of 2026. VYVGART (FcRn): – Ocular myasthenia gravis (oMG): Zai Lab partner argenx announced in February 2026 that the Phase 3 ADAPT OCULUS met its primary endpoint (p-value=0.012), demonstrating that patients living with oMG and treated with VYVGART demonstrated statistically significant improvement from baseline in Myasthenia Impairment Index (MGII) Patient Reported Outcome (PRO) ocular scores at Week 4 compared to placebo. In the overall population, mean change from baseline in patients treated with VYVGART was a 4.04 point improvement in MGII PRO versus a mean change of 1.99 MGII PRO score in patients treated with placebo. VYVGART was well tolerated and had a favorable safety pro patients with oMG, consistent with prior studies. Zai Lab participated in the study in Greater China (mainland China, Hong Kong, Macau, and Taiwan, collectively). – Seronegative generalized myasthenia gravis (sn-gMG): In January 2026, the FDA accepted for Priority Review a supplemental Biologics License Application (sBLA) for the treatment of adults with acetylcholine receptor antibody (AChR-Ab) sn-gMG, with a Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2026. Zai Lab participated in the Phase 3 ADAPT SERON study in Greater China. KarXT (xanomeline and trospium chloride) (M1/M4-agonist): In December 2025, China’s NMPA approved the NDA for KarXT for the treatment of schizophrenia in adults. KarXT is the first schizophrenia therapy with a novel mechanism of action approved in more than 70 years, offering a fundamentally new approach to treating schizophrenia. The commercial launch in China is planned for the second quarter of 2026. Povetacicept (APRIL/BAFF): In December 2025, Zai Lab joined the global pivotal Phase 2/3 OLYMPUS study in primary membranous nephropathy (pMN) and dosed the first patient in mainland China. The FDA granted Fast Track and Orphan Drug designations for povetacicept in pMN, and the EMA has granted Priority Medicines (PRIME) designation. Elegrobart (anti-IGF-1R, subcutaneous): In December 2025, Zai Lab dosed the first patient in a registrational study in thyroid eye disease (TED) in mainland China. Partner Viridian plans to report topline results from two global registrational studies in patients with active TED and chronic TED in the first half of 2026. Anticipated Major Milestones in 2026 Expected Clinical Developments and Data Readouts Global Pipeline Zocilurtatug Pelitecan (zoci, DLL3 ADC) (formerly ZL-1310) Second-Line+ ES-SCLC: Zai Lab to present updated data on intracranial activity from the ongoing Phase 1 study in the first half of 2026. First-Line ES-SCLC: Zai Lab to provide data readout from the Phase 1 study evaluating zoci combination therapy (with atezolizumab and/or chemotherapy) in the second half of 2026 and advance zoci into a registrational study in 2026 based on emerging data. Zai Lab also plans to initiate a Phase 1 study to explore zoci in a novel combination in the first half of 2026. Extrapulmonary NECs: Zai Lab to provide data readout from the global Phase 1b portion of the ongoing Phase 1b/2 study evaluating zoci in patients with selected solid tumors in the first half of 2026 and advance into registrational development in 2026. ZL-1503 (IL-13/IL-31Rα) Zai Lab to provide the first-in-human data readout from the global Phase 1/1b study in 2026. Regional Pipeline Upcoming Potential NMPA Approvals Tisotumab Vedotin (Tissue Factor ADC) in recurrent or metastatic cervical cancer following progression on or after chemotherapy Tumor Treating Fields (TTFields) in locally advanced pancreatic cancer 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 study in Greater China. Povetacicept (APRIL/BAFF) IgA Nephropathy (IgAN) : Zai Lab partner Vertex remains on track to release interim analysis data of the global Phase 3 RAINIER study in the first half of 2026 and also complete the submission in the first half of 2026, if data from the interim analysis are supportive. The FDA has granted Breakthrough Therapy Designation for this indication. pMN: Zai Lab and partner Vertex plan to complete the Phase 2 portion of the global pivotal Phase 2/3 OLYMPUS study and initiate the Phase 3 portion in mid-2026. Elegrobart (anti-IGF-1R, subcutaneous) Viridian to provide topline results from the global registrational REVEAL-1 study in active TED patients in the first quarter of 2026 and global registrational REVEAL-2 study in chronic TED in the second quarter of 2026. Zai Lab, through its license agreement with Zenas, obtained a sublicense to the Viridian anti-IGF-1R antibody and is proceeding with clinical development. Conference Call and Webcast Information Zai Lab will host a live conference call and webcast today, February 26, 2026, at 8:00 a.m. ET (9:00 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 worldwide. 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. Contacts For more information, please contact: 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 Read full story here

Phase 1Phase 3License out/inDrug ApprovalBreakthrough Therapy

24 Feb 2026

·www.prnewswire.com

Jazz Pharmaceuticals Announces Full Year and Fourth Quarter 2025 Financial Results and Provides 2026 Financial Guidance

– Record total revenues of $4.3 billion in 2025 (+5% YoY) and $1.2 billion (+10% YoY) in 4Q25 – – Expect to complete sBLA submission in 1Q26 under RTOR for zanidatamab in HER2+ 1L GEA – – Xywav® achieved $1.7 billion in revenue and 12% YoY growth in 2025 – – Epidiolex® achieved $1.1 billion in revenue and 9% YoY growth in 2025 – – Strong Modeyso™ launch with $37 million in revenue in first full quarter on market – – Expect 2026 total revenues of $4.25 to $4.50 billion – DUBLIN, Feb. 24, 2026 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the full year and fourth quarter of 2025 and provided financial guidance for 2026. "2025 was an exceptional year for Jazz, representing our 21st consecutive year of top-line growth and underscoring our commitment to operational excellence as we deliver meaningful innovation for patients," said Renee Gala, president and chief executive officer of Jazz Pharmaceuticals. "In the fourth quarter, our disciplined execution resulted in $1.2 billion in revenue, reflecting 10% year-over-year growth and our highest revenue quarter ever. This performance provides us with strong momentum into 2026, as we prepare for the potential launch of zanidatamab in GEA, sustain launch execution for Modeyso and Zepzelca®, and reinforce the differentiated profiles of Epidiolex and Xywav as the leading branded treatments for epilepsy and narcolepsy, respectively. In parallel, we continue to advance our pipeline and pursue a corporate development strategy aligned with our rare disease focus that supports durable growth and long-term value creation for patients and shareholders." "Jazz had a transformative year across our R&D pipeline, led by the HERIZON-GEA-01 data, which we believe firmly positions zanidatamab as the HER2-targeted agent of choice, with the potential to reshape first-line treatment for HER2+ metastatic GEA patients," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. "We expect to build on this progress in 2026, as these results not only highlight zanidatamab's potential to help patients with GEA, but also de-risk our clinical trials in additional indications, including HER2+ metastatic breast cancer." Key 2025 Highlights Total revenues in 2025 grew to $4.3 billion (+5% year-over-year (YoY)), generating $1.4 billion in cash from operations. Research & Development: Practice-changing Phase 3 HERIZON-GEA-01 results support zanidatamab as the HER2-targeted agent of choice in HER2+ 1L gastroesophageal adenocarcinoma (GEA), regardless of PD-L1 status. Multiple registrational trials of zanidatamab are underway, including in metastatic breast cancer (mBC), supporting a broad development program designed to maximize patient impact and long-term shareholder value. Commercial: Continued leadership in rare sleep with Xywav net product sales increasing to $1.7 billion (+12% YoY) and total sleep franchise1 revenues exceeding $2 billion in 2025. Epidiolex/Epidyolex® generated more than $1 billion in 2025 net product sales (+9% YoY). Completed acquisition of Chimerix Inc., secured FDA approval for and successfully launched Modeyso (dordaviprone) in H3 K27M-mutant diffuse midline glioma, achieving $48 million in sales since launch in August 2025. Received FDA approval and launched Zepzelca, in combination with atezolizumab, for first-line maintenance treatment of extensive-stage small cell lung cancer. Company expects 2026 total revenue of between $4.25 and $4.50 billion, with double-digit growth across the combined epilepsy and oncology franchises, and Xywav revenue flat to up mid-single digits. Tom Riga was named chief business officer to accelerate corporate development efforts across rare disease. Business Updates Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution: Xywav net product sales increased 12% to $1.7 billion in 2025 and increased 16% to $465 million in 4Q25 compared to the same periods in 2024. Strong new patient growth continued, with approximately 500 net patient adds in 4Q25. There were approximately 16,175 active patients exiting the quarter, comprised of approximately 10,950 narcolepsy patients and approximately 5,225 idiopathic hypersomnia (IH) patients. Epidiolex/ Epidyolex (cannabidiol): Epidiolex/Epidyolex achieved blockbuster status in 2025 with net product sales increasing 9% to $1.1 billion in 2025 and increasing 4% to $287 million in 4Q25 compared to the same periods in 2024. Ziihera® (zanidatamab-hrii): Ziihera net product sales in biliary tract cancer (BTC) were $25 million in 2025 and $9 million in 4Q25 following product launch in December 2024. Expect to complete supplemental biologics license application (sBLA) submission under Real Time Oncology Review (RTOR) in 1Q26 with potential launch in 1L HER2+ GEA in 2H26. FDA granted Breakthrough Therapy designation (BTD) for zanidatamab's development for patients with HER2+ unresectable locally advanced or metastatic GEA. Submitted HERIZON-GEA-01 data for potential inclusion in National Comprehensive Cancer Network (NCCN) guidelines. EmpowHER-BC-303 trial in mBC patients previously treated with, or intolerant to, trastuzumab deruxtecan on track to complete enrollment in 1H27, with top-line results expected in late 2027 or early 2028. Modeyso (dordaviprone): Following product launch in August 2025, Modeyso net product sales were $48 million in 2025 and $37 million in 4Q25. The Company sold its Rare Pediatric Disease Priority Review Voucher for gross proceeds of $200 million (50% to Jazz). Zepzelca (lurbinectedin): Zepzelca net product sales decreased 4% to $307 million in 2025 and increased 15% to $90 million in 4Q25 compared to the same periods in 2024. Financial Highlights Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release. Total Revenues Total revenues increased 5% in 2025 and 10% in 4Q25 compared to the same periods in 2024. Total neuroscience revenue, including high-sodium oxybate AG royalty revenue, was $3.1 billion in 2025, an increase of 6% compared to $2.9 billion in 2024, and $848 million in 4Q25, an increase of 8% compared to $786 million in 4Q24. The increase in both periods was primarily due to higher Xywav and Epidiolex/Epidyolex net product sales, partially offset by decreased Xyrem net product sales. Oncology net product sales were $1.1 billion in 2025, an increase of 2% compared to 2024, and $337 million in 4Q25, an increase of 16% compared to $292 million in 4Q24, primarily due to the inclusion of Modeyso and Ziihera net product sales in both periods. The increase in 4Q25 also included higher Zepzelca net product sales, partially offset by decreased Vyxeos® net product sales. Operating Expenses and Income Tax (Benefit) Expense Changes in operating expenses and income tax (benefit) expense in 2025 and 4Q25 over the prior year periods are primarily due to the following: Cost of product sales, on a GAAP and non-GAAP adjusted basis, increased in 2025 compared to 2024, primarily due to changes in product mix. Cost of product sales, on a GAAP basis, in 2025 included higher acquisition accounting inventory fair value step up expense compared to 2024. Cost of product sales, on a GAAP and non-GAAP adjusted basis, increased in 4Q25 compared to 4Q24, primarily due to changes in product mix, partially offset by lower inventory provisions. Selling, general and administrative (SG&A) expenses, on a GAAP and non-GAAP adjusted basis, increased in 2025 compared to 2024, primarily due to Xyrem antitrust litigation settlements of $234 million, the Avadel litigation settlement of $90 million and higher compensation-related expenses. SG&A expenses, on a GAAP and non-GAAP adjusted basis, increased in 4Q25 compared to 4Q24, primarily due to higher compensation-related expenses. Research and development (R&D) expenses, on a GAAP and non-GAAP adjusted basis, decreased in 2025 and 4Q25, compared to the same periods in 2024, primarily due to lower clinical study costs primarily related to zanidatamab as a result of timing of clinical trial activities, JZP385 (essential tremor) following discontinuation of this program, and JZP258 (XYLO/DUET) due to the completion of these trials in the first half of 2025, partially offset by the addition of costs relating to Modeyso and increased personnel costs following the acquisition of Chimerix. Acquired in-process research and development (IPR&D) in 2025, on a GAAP and non-GAAP adjusted basis, represents the value allocated to Modeyso in the Chimerix Acquisition of $905 million and the upfront payment made in connection with our global license agreement with Saniona of $43 million. Income tax benefit in 2025, on a GAAP and non-GAAP adjusted basis, included a benefit of $213 million on recognition of certain U.S. federal and state deferred tax assets acquired through the Chimerix acquisition. Income tax benefit, on a GAAP and non-GAAP adjusted basis, in 4Q24 was primarily due to patent box benefits recognized. Cash Flow and Balance Sheet As of December 31, 2025, cash, cash equivalents and investments were $2.4 billion, and the outstanding principal balance of the Company's long-term debt was $5.4 billion. In addition, the Company had undrawn borrowing capacity under a revolving credit facility of $885 million. For the year ended December 31, 2025, the Company generated $1.4 billion of cash from operations reflecting strong business performance and continued financial discipline. 2026 Financial Guidance Jazz Pharmaceutical's full year 2026 financial guidance is as follows: Conference Call Details Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. ET (9:30 p.m. GMT) to provide a business and financial update and discuss its 2025 full year and 4Q25 results and 2026 guidance. Interested parties may register for the call here or via the Investors section of the Jazz Pharmaceuticals website at . To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. A replay of the webcast will be available via the Investors section of the Jazz Pharmaceuticals website at . About Jazz Pharmaceuticals Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with rare disease — often with limited or no therapeutic options. We have a diverse portfolio of medicines, including leading therapies addressing epilepsies, cancers and sleep disorders. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Non-GAAP Financial Measures To supplement Jazz Pharmaceuticals' financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP (also referred to as adjusted or non-GAAP adjusted) financial measures in this press release and the accompanying tables. In particular, the Company presents non-GAAP adjusted net income (and the related per share measure) and its line-item components, as well as certain non-GAAP adjusted financial measures derived therefrom, including non-GAAP adjusted gross margin percentage and non-GAAP adjusted effective tax rate. Non-GAAP adjusted net income (and the related per share measure) and its line-item components exclude from GAAP reported net income (loss) (and the related per share measure) and its line-item components certain items, as detailed in the reconciliation tables that follow, and in the case of non-GAAP adjusted net income (and the related per share measure), adjust for the income tax effect of the non-GAAP adjustments. In this regard, the components of non-GAAP adjusted net income, including non-GAAP adjusted cost of product sales, SG&A expenses and R&D expenses, are income statement line items prepared on the same basis as, and therefore components of, the overall non-GAAP adjusted net income measure. The Company believes that each of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors and analysts and that each of these non-GAAP financial measures, when considered together with the Company's financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare the Company's results from period to period, to its forward-looking guidance, and to identify operating trends in the Company's business. In addition, these non-GAAP financial measures are regularly used by investors and analysts to model and track the Company's financial performance. Jazz Pharmaceuticals' management also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate the Company's business and to make operating decisions, and compensation of executives is based in part on certain of these non-GAAP financial measures. Because these non-GAAP financial measures are important internal measurements for Jazz Pharmaceuticals' management, the Company also believes that these non-GAAP financial measures are useful to investors and analysts since these measures allow for greater transparency with respect to key financial metrics the Company uses in assessing its own operating performance and making operating decisions. These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles in the reconciliation tables that follow. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its non-GAAP financial measures; and the Company has ceased, and may in the future cease, to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. In this regard, commencing with the first quarter of 2025, the Company is no longer including an adjustment for non-cash interest expense in the Company's non-GAAP adjusted financial measures. For purposes of comparability, non-GAAP adjusted financial measures for the 2024 periods have been updated to reflect this change. Likewise, the Company may determine to modify the nature of its adjustments to arrive at its non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by Jazz Pharmaceuticals in this press release and the accompanying tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. Cautionary Note Concerning Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to: the Company's growth prospects and future financial and operating results, including the Company's 2026 financial guidance and the Company's expectations related thereto, including with respect to anticipated catalysts; anticipated multiple near-term pipeline catalysts that each represent significant opportunities to drive greater revenue and create long-term value; the Company's advancement of pipeline programs and the timing of development activities, regulatory activities, approvals, and submissions related thereto, including the timing of the completion of the submission of the sBLA for, and launch and approval of, zanidatamab in 1L GEA; planned or anticipated clinical trial events, including with respect to initiations, enrollment and data read-outs, and the anticipated timing thereof; and the Company's development, regulatory and commercialization strategy; the Company's expectations with respect to its products and product candidates and the potential of the Company's products and product candidates and the potential regulatory path related thereto; including zanidatamab's potential to be the HER2-targeted agent of choice in HER2+ 1L GEA, regardless of PD-L1 status, and to reshape first-line treatment for HER2+ metastatic GEA patients; the Company's capital allocation and corporate development strategy; the potential successful future development, manufacturing, regulatory and commercialization activities; the Company's ability to realize the commercial potential of its products; the Company's net product sales and goals for net product sales from new and acquired products; the Company's views and expectations relating to its patent portfolio, including with respect to expected patent protection, as well as expectations with respect to exclusivity; the Company's clinical trials confirming clinical benefit or enabling regulatory submissions, including the potential of the ongoing Phase 3 ACTION trial to confirm clinical benefit of Modeyso in recurrent H3 K27M-mutant diffuse glioma and extend to use in first-line patients; and other statements that are not historical facts. These forward-looking statements are based on the Company's current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward- looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: maintaining or increasing sales of, and revenue from, Xywav, Epidiolex/Epidyolex, Ziihera, Modeyso, Zepzelca and other lead marketed products; effectively launching and commercializing the Company's other products and product candidates; the successful completion of development and regulatory activities with respect to the Company's product candidates; obtaining and maintaining adequate coverage and reimbursement for the Company's products; the time-consuming and uncertain regulatory approval process, including the risk that the Company's current and/or planned regulatory submissions may not be submitted, accepted or approved by applicable regulatory authorities in a timely manner or at all, including the risk that the Company's sBLA submission for zanidatamab in 1L GEA may not be completed or, if completed, approved in a timely manner or at all; the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success, including risks related to failure or delays in successfully initiating or completing clinical trials and assessing patients; global economic, financial, and healthcare system disruptions and the current and potential future negative impacts to the Company's business operations and financial results; protecting and enhancing the Company's intellectual property rights and the Company's commercial success being dependent upon the Company obtaining, maintaining and defending intellectual property protection and exclusivity for its products and product candidates; delays or problems in the supply or manufacture of the Company's products and product candidates; complying with applicable U.S. and non-U.S. regulatory requirements, including those governing the research, development, manufacturing and distribution of controlled substances; government investigations, legal proceedings and other actions; identifying and consummating corporate development transactions, financing these transactions and successfully integrating acquired products, product candidates and businesses; the Company's ability to realize the anticipated benefits of its collaborations and license agreements with third parties; the sufficiency of the Company's cash flows and capital resources; the Company's ability to achieve targeted or expected future financial performance and results and the uncertainty of future tax, accounting and other provisions and estimates; the Company's ability to meet its projected long-term goals and objectives, in the time periods that the Company anticipates, or at all, and the inherent uncertainty and significant judgments and assumptions underlying the Company's long-term goals and objectives; fluctuations in the market price and trading volume of the Company's ordinary shares; and other risks and uncertainties affecting the Company, including those described from time to time under the caption "Risk Factors" and elsewhere in the Company's Securities and Exchange Commission filings and reports, including the Company's Annual Report on Form 10-K for the year ended December 31, 2025, and future filings and reports by the Company. Other risks and uncertainties of which the Company is not currently aware may also affect the Company's forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. Contacts: Investors: [email protected] Ireland +353 1 634 3211 U.S. +1 650 496 2717 Media: [email protected] Ireland +353 1 637 2141 U.S. +1 215 867 4948 Logo - 21% more press release views with Request a Demo

Drug ApprovalBreakthrough TherapyPhase 3AcquisitionFinancial Statement

12 Jan 2026

·firstwordpharma.com

FDA lifts partial hold on Daiichi, Merck & Co.'s ADC lung cancer study

The FDA has lifted a partial clinical hold on the Phase III IDeate-Lung02 trial testing the experimental antibody-drug conjugate (ADC) ifinatamab deruxtecan (I-DXd) in patients with relapsed small-cell lung cancer (SCLC), Daiichi Sankyo confirmed to FirstWord on Monday.The therapy is being developed under a broad ADC collaboration signed with Merck & Co. in 2023, in which the latter paid Daiichi $4 billion upfront and committed up to $22 billion in potential milestones.A "higher than anticipated" incidence of grade 5 interstitial lung disease (ILD) events had triggered a global pause on enrolment in December, though patients already in the trials could still receive treatment. The news had dented Daiichi shares by 3.5% at the time, but Jefferies analysts argued that the market overreacted, noting that other I-DXd trials, including the Phase II IDeate-Lung01 study, continued to progress.According to Daiichi, the FDA lifted the partial hold after additional safety measures targeting ILD and pneumonitis were implemented.Mandatory trainingUnder the revised protocol, patients at higher risk for ILD/pneumonitis are now excluded, and an independent data monitoring committee will conduct more frequent reviews of unblinded safety and efficacy data to share with the FDA. Mandatory training is also under way for investigators and clinical site staff to ensure proper recognition and management of ILD/pneumonitis. Enrollment of new US patients will resume once this training is complete.The trial remains on a temporary enrolment pause in the EU, where Daiichi and Merck are continuing discussions with regulators on next steps.IDeate-Lung02 is testing I-DXd against physician's choice chemotherapy — amrubicin, lurbinectedin or topotecan — in SCLC patients whose disease progressed on or after one prior platinum-based chemotherapy. Eligible participants are randomised to receive I-DXd at a dose of 12 mg/kg or physician's choice of treatment.

ADCPhase 2Phase 3Clinical Trial TerminationPhase 1

100 Deals associated with Lurbinectedin

External Link

KEGG	Wiki	ATC	Drug Bank
D11644	Lurbinectedin	L01XX	DB12674

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Extensive stage Small Cell Lung Cancer	United States	Jazz Pharmaceuticals Ireland Ltd.	02 Oct 2025
Small Cell Lung Cancer	United States	Jazz Pharmaceuticals Ireland Ltd.	15 Jun 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Leiomyosarcoma	Phase 3	United States	Pharma Mar SA	21 Sep 2023
Leiomyosarcoma	Phase 3	Austria	Pharma Mar SA	21 Sep 2023
Leiomyosarcoma	Phase 3	Belgium	Pharma Mar SA	21 Sep 2023
Leiomyosarcoma	Phase 3	France	Pharma Mar SA	21 Sep 2023
Leiomyosarcoma	Phase 3	Germany	Pharma Mar SA	21 Sep 2023
Leiomyosarcoma	Phase 3	Italy	Pharma Mar SA	21 Sep 2023
Leiomyosarcoma	Phase 3	Netherlands	Pharma Mar SA	21 Sep 2023
Leiomyosarcoma	Phase 3	Poland	Pharma Mar SA	21 Sep 2023
Leiomyosarcoma	Phase 3	Portugal	Pharma Mar SA	21 Sep 2023
Leiomyosarcoma	Phase 3	Spain	Pharma Mar SA	21 Sep 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05091567 (IMforte \| IMforte，GO43104, CTgov)	Phase 3	Extensive stage Small Cell Lung Cancer	660	Atezolizumab (Atezolizumab)	sngawqznqw(sshipumbzj) = tvkwdxxkua dzmooldlih (tkouzxujpr, sjhbngsepv - nxkxqkhyxr) View more	-	29 Dec 2025
				Lurbinectedin+Atezolizumab (Atezolizumab+ Lurbinectedin)	sngawqznqw(sshipumbzj) = tqyzubddne dzmooldlih (tkouzxujpr, ehjfaxlklc - fnlypbqrqr) View more
NCT05091567 (IMforte, ESMO2025) Manual	Phase 3	Extensive stage Small Cell Lung Cancer First line \| Maintenance	483	Lurbinectedin + Atezolizumab	xozhtgswzj(ibjfesoqce) = seqynlsvzz ydxilrigzv (mkrvtokqxq ) View more	Positive	17 Oct 2025
				Atezolizumab	xozhtgswzj(ibjfesoqce) = cwlpouthim ydxilrigzv (mkrvtokqxq ) View more
NCT05876715 (ESMO2025)	Phase 1/2	Locally Advanced Soft Tissue Sarcoma First line	40	Lurbinectedin + Ipilimumab + Nivolumab (Phase 1)	faxnztlrlu(ppnywjsehr) = afquqhqedj crcoopifka (vjrkdnxxnx ) View more	Positive	17 Oct 2025
				Lurbinectedin + Ipilimumab + Nivolumab (Phase 2)	uczqlbrike(izzrnbkwdv) = dxykrghhju imcgedusgr (rwidofvnbj ) View more
NCT05072106 (CTgov)	Phase 1	Advanced Malignant Solid Neoplasm	11	Lurbinectedin+Bosentan (Bosentan Co-administration Cycle)	ubjogyuccl(ibijrckfal) = cecgeuzcwu dnuewtijjq (odcwwdblkb, 54.81) View more	-	16 Sep 2025
				Lurbinectedin (Single Agent Lurbinectedin Cycle)	ubjogyuccl(ibijrckfal) = vwdtzfmkbw dnuewtijjq (odcwwdblkb, 49.56) View more
NCT05063318 (CTgov)	Phase 1	Advanced Malignant Solid Neoplasm	14	lurbinectedin+ITZ (ITZ+LRB)	zdlosijyix(msqwbgzqkr) = xunifzwexu cmfgvdqqzp (vcoyeygdkb, 73.9) View more	-	02 Sep 2025
				LRB (LRB Alone)	zdlosijyix(msqwbgzqkr) = ffphqcsdlz cmfgvdqqzp (vcoyeygdkb, 77.37) View more
NCT05091567 (IMforte, Pubmed \| Lancet) Manual	Phase 3	Extensive stage Small Cell Lung Cancer First line \| Maintenance	483	Lurbinectedin + Atezolizumab	ihraroyzup(vauaxgzdnq): HR = 0.54 (95% CI, 0.43 - 0.67), P-Value = <0.0001 View more	Positive	01 Jun 2025
				Atezolizumab
NCT04253145 (2SMALL, ASCO2025) Manual	Phase 1/2	Advanced Lung Small Cell Carcinoma Second line	151	lurbinectedin + atezolizumab (Cohort 1, progression after one prior platinum-based chemotherapy alone)	qzdcqbdegz(dlvkqweyzp) = vwrjermmwz uxopydrgjb (naarbitioa, 32.27 - 56.63) View more	Positive	30 May 2025
				lurbinectedin + atezolizumab (Cohort 2, combined with PD-1/ PD-L1 blockade)	qzdcqbdegz(dlvkqweyzp) = cogpnwtgax uxopydrgjb (naarbitioa, 27.18 - 48.7) View more
NCT05091567 (IMforte, ASCO2025) Manual	Phase 3	Extensive stage Small Cell Lung Cancer Maintenance \| First line	660	Lurbinectedin + Atezolizumab	oxdukqtxtc(zatkqnvaav) = lcqembtaza cocyjqszuh (wkkpqbeewg, 4.2 - 5.8) View more	Positive	30 May 2025
				Atezolizumab	oxdukqtxtc(zatkqnvaav) = jmslrfnbih cocyjqszuh (wkkpqbeewg, 1.6 - 2.7) View more
ASCO2025	Not Applicable	Extensive stage Small Cell Lung Cancer Second line	256	Lurbinectedin	aksiksxmzc(vwxdioqizk) = kircayvyhl gryvmafhxi (utkupopgga, 0.681 - 0.685) View more	Positive	30 May 2025
ASCO2025	Not Applicable	Small Cell Lung Cancer Second line \| Third line	61	Lurbinectedin as second-line therapy	hkkigbzndk(eczdvxxtqp) = 37.5% fptcwuyrje (neaskwithl ) View more	Positive	30 May 2025
				Lurbinectedin as third-line therapy

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis