Background:
Neuroblastoma is a type of cancer that causes tumors in nerves. It affects mainly infants and toddlers, and it causes about 15 percent of cancer-related deaths in children.
Objective:
To test a new drug (rhIL-15), combined with 3 standard cancer drugs, in people with neuroblastoma.
Eligibility:
People aged 3 to 35 years with neuroblastoma that did not respond or returned after standard treatment.
Design:
Participants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and tests of their heart and lungs. They will have a bone marrow biopsy: A sample of tissue and fluid from inside a bone will be removed with a large needle.
Participants will be treated in 21-day cycles. They may have up to 4 treatment cycles.
rhIL-15 is given through a needle into a vein over 5 to 7 days during the first week of each cycle. Participants will stay in the hospital while they are receiving the rhIL-15.
Starting in the second week of the second cycle, participants will receive other drugs for treating cancer. They will have no study treatments during the third week of each cycle.
Participants will visit the clinic at least 2 times a week throughout all 4 treatment cycles. They will have a physical exam and blood tests during these visits. Imaging scans, bone marrow biopsy, and other tests will be repeated at the end of cycles 2 and 4.
Participants will have a follow-up visit 6 months after treatment ends. This visit will include a physical exam with blood and urine tests.

开始日期2025-10-21

申办/合作机构

National Cancer Institute

NCT06450041

/ Active, not recruiting临床2期IIT

Phase II Study of Ex-Vivo Expanded Allogeneic Universal Donor TGFβi NK Cell Infusions in Combination With Temozolomide, Irinotecan, Dinutuximab, and Sargramostim in Patients With Relapsed or Refractory Neuroblastoma The STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial

This is a phase II study looking at patient response to treatment with the combination dinutuximab, temozolomide, irinotecan, and GM-CSF.

开始日期2024-12-16

申办/合作机构

United Therapeutics Corp.

[+1]

NCT06172296

/ Recruiting临床3期IIT

A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma

This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy works for treating children with newly diagnosed high-risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found on the surface of neuroblastoma cells, but is not present on many healthy or normal cells in the body. When dinutuximab binds to the neuroblastoma cells, it helps signal the immune system to kill the tumor cells. This helps the cells of the immune system kill the cancer cells, this is a type of immunotherapy. When chemotherapy and immunotherapy are given together, during the same treatment cycle, it is called chemoimmunotherapy. This clinical trial randomly assigns patients to receive either standard chemotherapy and surgery or chemoimmunotherapy (chemotherapy plus dinutuximab) and surgery during Induction therapy. Chemotherapy drugs administered during Induction include, cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, and doxorubicin. These drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. Upon completion of 5 cycles of Induction therapy, a disease evaluation is completed to determine how well the treatment worked. If the tumor responds to therapy, patients receive a tandem transplantation with stem cell rescue. If the tumor has little improvement or worsens, patients receive chemoimmunotherapy on Extended Induction. During Extended Induction, dinutuximab is given with irinotecan, temozolomide. Patients with a good response to therapy move on to Consolidation therapy, when very high doses of chemotherapy are given at two separate points to kill any remaining cancer cells. Following, transplant, radiation therapy is given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of Induction. The final stage of therapy is Post-Consolidation. During Post-Consolidation, dinutuximab is given with isotretinoin, with the goal of maintaining the response achieved with the previous therapy. Adding dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy may be better at treating children with newly diagnosed high-risk neuroblastoma.

开始日期2024-04-19

申办/合作机构

National Cancer Institute

100 项与 Dinutuximab 相关的临床结果

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100 项与 Dinutuximab 相关的转化医学

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100 项与 Dinutuximab 相关的专利（医药）

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207

项与 Dinutuximab 相关的文献（医药）

2025-12-01·MOLECULAR BIOLOGY REPORTS

Advancements in neuroblastoma treatment: FDA-approved drugs and role of phytochemicals

Review

作者: Chandel, Shivani ; Kumar, Rajneesh ; Rajpoot, Satyapal ; Singh, Rajveer

Neuroblastoma (NB) is a solid Pediatric tumor that forms in immature nerve cells. Commonly affecting the adrenal glands, spinal cord, or neck. This cancer is prevalent in children under five years old and accounts for over 15% of cancer-related deaths in this age group. Low-risk tumors can be treated surgically, intermediate-risk tumors require surgery and chemotherapy, and radiation therapy for high-risk Advancements in treatment through FDA-approved drugs and plant-derived compounds. FDA-approved drugs like Entrectinib, Dinutuximab, Unitaxin, Doxorubicin, Hydrochloride, Lorlatinib, and Crizotinib are pivotal in treating neuroblastoma. These agents inhibit pathways such as TrkA/B/C, ROS, and ALK, and the GD2 antigen. In addition to these therapies, phytochemicals have emerged as promising anticancer agents. Compounds such as quercetin, rutin, chalcone, gedunine, lycorine, withaferin A, and resveratrol have anti-cancer properties in preclinical models, targeting tumor growth and apoptosis pathways. These are improving the prevention of tumor growth through cross-reactions. Additional plant extracts have exhibited activity against neuroblastoma. This review highlights the synergistic potential of FDA-approved drugs and plant-derived phytoconstituents in improving neuroblastoma treatment outcomes.

2025-11-01·APPLIED RADIATION AND ISOTOPES

Automated zirconium-89 and lutetium-177 antibody labeling and formulation using a Trasis MiniAIO module

Article

作者: van der Wildt, Berend ; Vlaswinkel, Carlijn A ; Koorn, Nathalie J ; Poot, Alex J ; Spoormans, Stijn A

INTRODUCTION:

Radiolabeled antibodies are used to select the right treatment for the right patient by determining antigen expression levels in vivo. In addition, antibodies labeled with therapeutic nuclides can be used for cancer treatment. To efficiently produce these labeled antibodies in constant high quality, automated procedures are desired. This research describes the labeling and formulation of zirconium-89 and lutetium-177 labeled Dinutuximab on the Trasis MiniAIO module, as proof-of-principle antibody to be used for GD2 imaging and therapy in neuroblastoma patients.

METHODS:

Dinutuximab was modified for labeling with a DFO- or DOTA-chelator using isothiocyanate chemistry. Radiolabeling with zirconium-89 and lutetium-177 and subsequent purification and formulation were performed using the Trasis MiniAIO and compared to manual synthesis procedures. Radiochemical purity was assessed by iTLC and HPLC. Immunoreactivity was evaluated using a radioligand binding assay on antigen coated wells.

RESULTS:

Radiolabeled products were obtained with good radiochemical yield of 76 ± 8 % for [⁸⁹Zr]Dinutuximab 70 ± 8 % for [¹⁷⁷Lu]Dinutuximab. Immunoreactivity was >50 % for zirconium-89 and lutetium-177 labeled constructs, which was similar to immunoreactivity of products obtained by manual synthesis. Manually obtained radiochemical yields were somewhat higher as a result of residual radioactivity in valves and tubings in automated synthesis runs, however losses were minimized through incorporation of several washing steps. Generally, yields were comparable with previously reported automation procedures and importantly, satisfactory for human application.

CONCLUSION:

We have developed a reproducible and high-yielding automated method for the synthesis and formulation of radiolabeled diagnostic and therapeutic antibodies on a Trasis MiniAIO module. This method should assist in obtaining labeled products with consistent quality while simultaneously reducing the workers radiation dose.

2025-09-01·PEDIATRIC BLOOD & CANCER

Pulmonary Toxicity Associated With Concurrent Lorlatinib and Anti‐GD2 Monoclonal Antibody Therapy in Patients With Neuroblastoma

Article

作者: Wei, Wei ; Modak, Shakeel ; Kramer, Kim ; Cardenas, Fiorella Iglesias ; Basu, Ellen ; Fader, Maggie Eidson ; Kushner, Brian H.

ABSTRACT:

Background:

The anaplastic lymphoma kinase (ALK) inhibitor lorlatinib demonstrated safety without pulmonary toxicity in early‐phase trials in patients with neuroblastoma. Lorlatinib is being tested with chemotherapy and immunotherapy in the Children's Oncology Group study ANBL1531. However, pulmonary toxicity was noted in patients receiving lorlatinib concurrently with anti‐disialoganglioside 2 (GD2) monoclonal antibody (mAb) dinutuximab on the trial.

Methods:

After IRB approval, we performed a retrospective review on patients with neuroblastoma treated with lorlatinib and anti‐GD2 mAbs from 9/2020 to 11/2024. Before 11/2023, lorlatinib was given concurrently with anti‐GD2 mAbs; after 11/2023, it was withheld during mAb immunotherapy.

Results:

Twenty‐nine patients received lorlatinib with naxitamab (n = 12), dinutuximab (n = 11), or both (n = 6). Eight, 8, and 13 patients received lorlatinib with chemoimmunotherapy, mAbs, and both, respectively. Twenty of the 29 patients were treated with a total of 160 cycles before 11/2023, and 4 developed ≥grade 3 pulmonary toxicity. Severe respiratory failure with hemodynamic instability and the need for mechanical ventilation and extracorporeal membrane oxygenation occurred in two patients. The other two patients experienced hypoxia, wheezing, or cough, both managed with supportive care. All four recovered to grade 2 pulmonary toxicities. Fifteen of the 29 patients were treated with 64 combined cycles after 11/2023, but none developed ≥grade 3 pulmonary toxicity.

Conclusions:

Concurrent use of lorlatinib with anti‐GD2 mAbs may be associated with severe pulmonary toxicities. Temporarily withholding lorlatinib during immunotherapy appeared to mitigate this risk.

项与 Dinutuximab 相关的新闻（医药）

2025-08-09

·生物制药进展杂评

核药小公司Y-mAbs，4亿美元卖身，技术平台的花样~

近日，全球特种制药公司SERB Pharmaceuticals宣布完成对抗癌药企Y-mAbs Therapeutics的全面收购，交易总价值达4.12亿美元。此次收购以全现金形式进行。 Y-mAbs 看名字就是跟抗体相关，主要做核药~目前有一个上市产品—— DANYELZA® （那昔妥单抗，naxitamab）是一款单抗产品，靶点为GD2，用于治疗神经母细胞瘤。 GD2靶点上市产品： GD2（二唾液酸神经节苷脂）是神经外胚层起源的肿瘤细胞表达的一种表面抗原，在多种癌症实体的细胞表面过表达，是癌症免疫治疗的合理靶点，达妥西单抗（dinutuximab）和那昔妥单抗（naxitamab）已获FDA批准用于治疗高危NB的维持治疗。达妥西单抗因表达系统不同又有两个产品Dinutuximab beta（CHO细胞表达）和Naxitamab（hu3F8）。 naxitamab和Dinutuximab beta在国内已经上市，没有看到全球销售数据，在国内2022和2021年上市，到2024年国内销售分别在1.4和 2.6以人民币左右， Naxitamab2024年全球销量大约在2.4亿美元。其他在研产品如下：进度最快还是GD2靶点的核药Radiopharmaceuticals Pipeline 主要技术平台——SADA PRIT Technology Platform，(SADA，Self-Assembly DisAssembly； PRIT ，Pre-Targeted Radioimmunotherapy) 分子结构是个四具体，如下：每个单体（~70kDa）各部分功能如下：进入体内发挥作用，有两步：第一步结合到肿瘤上，看示意图至少会有两个结合位点结合上去，这样就增加了靶向性，减少器官脱靶~ 没结合上的四聚体药物粉丝会分离成单体，然后代谢~ 第二步：就是核素分子发挥作用了~ 没有看到太具体的技术细节~ 但是理解下来，通过四聚体或者叫做四抗，提高结合能力，避免脱靶，这是主要的核心点。这点和双抗ADC有异曲同工之处~ 最后一下问题：GD2的在研产品中CART产品比较多大概有26个进入临床研究的产品，抗体药物只有8个。

并购抗体药物偶联物免疫疗法上市批准引进/卖出

2025-07-30

·Business Wire

United Therapeutics Corporation Reports Record Second Quarter 2025 Financial Results

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced record financial results for the quarter ended June 30, 2025, driven by continued double-digit year-over-year revenue growth in key products such as Tyvaso DPI, Nebulized Tyvaso, Orenitram, and Unituxin. Total revenues in the second quarter of 2025 grew 12 percent year-over-year to a record $798.6 million, compared to $714.9 million in the second quarter of 2024. “Our second quarter yet again produced record-setting results driven by the strength of our foundational commercial business,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. “We continue to believe there is no other biotech company like ours that provides this combination of sales growth and operating cash flow with near- to medium-term catalysts positioned for sustained long-term growth, starting with data from the TETON 2 study of nebulized treprostinil in idiopathic pulmonary fibrosis expected in September that could fundamentally improve options for patients with this progressive, deadly disease with few treatments available. “Equally, our strong financial position, confidence in these upcoming catalysts, and belief in our share price potential has led our Board of Directors to authorize up to $1 billion in share repurchases, affirming our commitment to a robust and balanced capital allocation philosophy.” Michael Benkowitz, President and Chief Operating Officer of United Therapeutics, added, “We’re proud of the continued record performance for Tyvaso DPI, a best-in-class treprostinil dry powder inhaler that allows the flexibility of one breath per cartridge, four times a day, with low inspiratory effort. Further, no other commercially available treprostinil dry powder inhaler has been clinically studied with published data at higher doses1,2 or prescribed by more physicians to more patients than Tyvaso DPI. “We expect continued double digit revenue growth for Tyvaso and total revenues well into the future through strong commercial execution of our existing product portfolio coupled with the potential for our late-stage pipeline in pulmonary fibrosis and pulmonary hypertension.” ________________________________ 1 Spikes, L. A., et al. (2024, October). Long-term outcomes and dosing in the BREEZE study optional extension phase. CHEST, 166(4, Suppl), A6061–A6063. https://doi.org/10.1016/j.chest.2024.06.3583 2 Burger, C.D., et al. Exploratory Efficacy Analysis of INSPIRE Open-Label Extension Study With Inhaled Treprostinil (YUTREPIA™). American Thoracic Society International Conference 2023. https://liquidia.com/static-files/d5275811-d1af-4ac5-80d4-9bb4b7262d74 Second Quarter 2025 Financial Results Key financial highlights include (dollars in millions, except per share data): Three Months Ended June 30, Dollar Change Percentage Change 2025 2024 Total revenues $ 798.6 $ 714.9 $ 83.7 12 % Net income $ 309.5 $ 278.1 $ 31.4 11 % Net income, per basic share $ 6.86 $ 6.26 $ 0.60 10 % Net income, per diluted share $ 6.41 $ 5.85 $ 0.56 10 % Revenues The table below presents the components of total revenues (dollars in millions): Three Months Ended June 30, Dollar Change Percentage Change 2025 2024 Net product sales: Tyvaso DPI®(1) $ 315.2 $ 258.3 $ 56.9 22 % Nebulized Tyvaso®(1) 154.4 139.9 14.5 10 % Total Tyvaso 469.6 398.2 71.4 18 % Remodulin®(2) 134.7 147.3 (12.6 ) (9 )% Orenitram® 123.9 107.1 16.8 16 % Unituxin® 58.4 51.7 6.7 13 % Adcirca® 6.5 5.7 0.8 14 % Other 5.5 4.9 0.6 12 % Total revenues $ 798.6 $ 714.9 $ 83.7 12 % (1) Net product sales include both the drug product and the respective inhalation device. (2) Net product sales include sales of infusion devices, including the Remunity® Pump. Total Tyvaso revenues grew by 18 percent to $469.6 million in the second quarter of 2025, compared to $398.2 million in the second quarter of 2024. The growth in Tyvaso DPI revenues resulted primarily from an increase in quantities sold of $54.6 million and, to a lesser extent, a price increase, partially offset by higher gross-to-net revenue deductions. The increase in Tyvaso DPI quantities sold was primarily due to continued growth in the number of patients following the product’s launch, including growth in utilization by patients with pulmonary hypertension associated with interstitial lung disease and, to a lesser extent, increased commercial utilization following the implementation of the Medicare Part D benefit redesign under the Inflation Reduction Act (IRA). The growth in Nebulized Tyvaso revenues resulted primarily from an increase in quantities sold and, to a lesser extent, a price increase. The growth in Orenitram revenues resulted primarily from an increase in quantities sold of $10.6 million and, to a lesser extent, a price increase, partially offset by higher gross-to-net revenue deductions. The increase in quantities sold was driven, at least in part, by increased commercial utilization following the implementation of the Medicare Part D benefit redesign under the IRA. The table below presents the breakdown of total revenues between the United States and rest-of-world (ROW) (in millions): Three Months Ended June 30, 2025 2024 U.S. ROW Total U.S. ROW Total Net product sales: Tyvaso DPI(1) $ 314.8 $ 0.4 $ 315.2 $ 258.3 $ — $ 258.3 Nebulized Tyvaso(1) 140.5 13.9 154.4 130.2 9.7 139.9 Total Tyvaso 455.3 14.3 469.6 388.5 9.7 398.2 Remodulin(2) 113.7 21.0 134.7 122.5 24.8 147.3 Orenitram 123.9 — 123.9 107.1 — 107.1 Unituxin 55.4 3.0 58.4 46.8 4.9 51.7 Adcirca 6.5 — 6.5 5.7 — 5.7 Other 5.0 0.5 5.5 4.6 0.3 4.9 Total revenues $ 759.8 $ 38.8 $ 798.6 $ 675.2 $ 39.7 $ 714.9 (1) Net product sales include both the drug product and the respective inhalation device. (2) Net product sales include sales of infusion devices, including the Remunity Pump. Expenses Cost of sales. The table below summarizes cost of sales by major category (dollars in millions): Three Months Ended June 30, Dollar Change Percentage Change 2025 2024 Category: Cost of sales $ 86.6 $ 75.9 $ 10.7 14 % Share-based compensation expense(1) 1.0 1.9 (0.9 ) (47 )% Total cost of sales $ 87.6 $ 77.8 $ 9.8 13 % (1) See Share-based compensation below. Cost of sales, excluding share-based compensation. Cost of sales for the three months ended June 30, 2025 increased as compared to the same period in 2024, primarily due to an increase in: (1) royalty expense resulting from a growth in revenues; and (2) reserve expense resulting from increased production. Research and development. The table below summarizes the nature of research and development expense by major expense category (dollars in millions): Three Months Ended June 30, Dollar Change Percentage Change 2025 2024 Category: External research and development(1) $ 62.4 $ 49.4 $ 13.0 26 % Internal research and development(2) 55.9 44.5 11.4 26 % Share-based compensation expense(3) 8.1 8.6 (0.5 ) (6 )% Other(4) 7.6 37.1 (29.5 ) (80 )% Total research and development expense $ 134.0 $ 139.6 $ (5.6 ) (4 )% (1) External research and development primarily includes fees paid to third parties (such as clinical trial sites, contract research organizations, and contract laboratories) for preclinical and clinical studies and payments to third-party contract manufacturers before FDA approval of the relevant product. (2) Internal research and development primarily includes salary-related expenses for research and development functions, internal costs to manufacture product candidates before FDA approval, and internal facilities-related expenses, including depreciation, related to research and development activities. (3) See Share-based compensation below. (4) Other primarily includes upfront fees and milestone payments to third parties under license agreements related to development-stage products and adjustments to the fair value of our contingent consideration obligations. Research and development, excluding share-based compensation. Research and development expense for the three months ended June 30, 2025 decreased as compared to the same period in 2024, primarily due to $36.0 million in upfront non-refundable license payments for drug delivery device technologies in 2024, partially offset by: (1) increased expenditures in 2025 related to manufactured organ and organ alternative projects; and (2) a $5.0 million milestone payment made in 2025 for drug delivery device technologies. Selling, general, and administrative. The table below summarizes selling, general, and administrative expense by major category (dollars in millions): Three Months Ended June 30, Dollar Change Percentage Change 2025 2024 Category: General and administrative(1) $ 131.1 $ 113.0 $ 18.1 16 % Impairment of property, plant, and equipment (PP&E) 21.7 — 21.7 NM(2) Sales and marketing 31.0 25.4 5.6 22 % Share-based compensation expense(3) 28.7 39.2 (10.5 ) (27 )% Total selling, general, and administrative expense $ 212.5 $ 177.6 $ 34.9 20 % (1) Excluding impairment of PP&E. See Impairment of PP&E section below. (2) Calculation is not meaningful. (3) See Share-based compensation below. General and administrative, excluding impairment of PP&E and share-based compensation. General and administrative expense for the three months ended June 30, 2025 increased as compared to the same period in 2024, primarily due to: (1) personnel expense due to growth in headcount; and (2) legal expenses related to litigation matters. Impairment of PP&E. During the three months ended June 30, 2025, we recorded a $21.7 million impairment charge to write down the carrying value of certain PP&E. Share-based compensation. The table below summarizes share-based compensation expense by major category (dollars in millions): Three Months Ended June 30, Dollar Change Percentage Change 2025 2024 Category: Stock options $ 11.1 $ 8.1 $ 3.0 37 % Restricted stock units 26.0 19.2 6.8 35 % Share tracking awards plan (STAP) — 21.9 (21.9 ) (100 )% Employee stock purchase plan 0.7 0.5 0.2 40 % Total share-based compensation expense $ 37.8 $ 49.7 $ (11.9 ) (24 )% The decrease in share-based compensation expense for the three months ended June 30, 2025, as compared to the same period in 2024, was primarily due to a decrease in STAP expense, as all remaining STAP awards were exercised during the first quarter of 2025. Income tax expense. Income tax expense for the three months ended June 30, 2025 and 2024 was $98.9 million and $77.2 million, respectively. Our effective income tax rate (ETR) for the three months ended June 30, 2025 and 2024 was 24 percent and 22 percent, respectively. Our ETR for the three months ended June 30, 2025 increased compared to our ETR for the three months ended June 30, 2024, primarily due to a decrease in excess tax benefits from share-based compensation. Webcast We will host a webcast to discuss our second quarter 2025 financial results on Wednesday, July 30, 2025, at 9:00 a.m. Eastern Time. The webcast can be accessed live via our website at https://ir.unither.com/events-and-presentations. An investor presentation is available now, and after the webcast a replay of the webcast will also be available, at the same location on our website. United Therapeutics: Enabling Inspiration At United Therapeutics, our vision and mission are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun; we do good. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. You can learn more about what it means to be a PBC here: unither.com/pbc. Forward-Looking Statements Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements related to our share repurchase program, the anticipated timing and outcome of the TETON 2 and TETON 1 clinical trials of Nebulized Tyvaso in idiopathic pulmonary fibrosis, including potential for these studies to improve options for patients with this disease; the anticipated readout of the ADVANCE OUTCOMES clinical trial of ralinepag; our near- to medium-term catalysts positioned for sustained long-term growth; our expectation of continued double digit revenue growth for Tyvaso and total revenues well into the future through strong commercial execution of our existing product portfolio coupled with the potential for our late-stage pipeline in pulmonary fibrosis and pulmonary hypertension; and our goals of innovating for the unmet medical needs of our patients and to benefit our other stakeholders, furthering our public benefit purpose of developing novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of July 30, 2025, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events, or any other reason. ORENITRAM, REMODULIN, REMUNITY, TYVASO, TYVASO DPI, and UNITUXIN are registered trademarks of United Therapeutics Corporation and/or its subsidiaries. ADCIRCA is a registered trademark of Eli Lilly and Company. UNITED THERAPEUTICS CORPORATION CONSOLIDATED STATEMENTS OF OPERATIONS (In millions, except per share data) Three Months Ended June 30, 2025 2024 (Unaudited) Total revenues $ 798.6 $ 714.9 Operating expenses: Cost of sales 87.6 77.8 Research and development 134.0 139.6 Selling, general, and administrative 212.5 177.6 Total operating expenses 434.1 395.0 Operating income 364.5 319.9 Interest income 51.3 46.2 Interest expense (7.3 ) (11.6 ) Other (expense) income, net (0.1 ) 0.8 Total other income, net 43.9 35.4 Income before income taxes 408.4 355.3 Income tax expense (98.9 ) (77.2 ) Net income $ 309.5 $ 278.1 Net income per common share: Basic $ 6.86 $ 6.26 Diluted $ 6.41 $ 5.85 Weighted average number of common shares outstanding: Basic 45.1 44.4 Diluted 48.3 47.5 SELECTED CONSOLIDATED BALANCE SHEET DATA (Unaudited, in millions) June 30, 2025 Cash, cash equivalents, and marketable investments $ 4,966.4 Total assets 7,908.0 Total liabilities 734.4 Total stockholders’ equity 7,173.6 Category: Earnings

财报

2025-07-30

·ir.unither.com

United Therapeutics Corporation Reports Record Second Quarter 2025 Financial Results

________________________________ 1 Spikes, L. A., et al. (2024, October). Long-term outcomes and dosing in the BREEZE study optional extension phase. CHEST, 166(4, Suppl), A6061–A6063. https://doi.org/10.1016/j.chest.2024.06.3583 2 Burger, C.D., et al. Exploratory Efficacy Analysis of INSPIRE Open-Label Extension Study With Inhaled Treprostinil (YUTREPIA™). American Thoracic Society International Conference 2023. https://liquidia.com/static-files/d5275811-d1af-4ac5-80d4-9bb4b7262d74 Three Months EndedJune 30, DollarChange PercentageChange 2025 2024 Total revenues $ 798.6 $ 714.9 $ 83.7 12 % Net income $ 309.5 $ 278.1 $ 31.4 11 % Net income, per basic share $ 6.86 $ 6.26 $ 0.60 10 % Net income, per diluted share $ 6.41 $ 5.85 $ 0.56 10 % Three Months EndedJune 30, Dollar Change PercentageChange 2025 2024 Net product sales: Tyvaso DPI®(1) $ 315.2 $ 258.3 $ 56.9 22 % Nebulized Tyvaso®(1) 154.4 139.9 14.5 10 % Total Tyvaso 469.6 398.2 71.4 18 % Remodulin®(2) 134.7 147.3 (12.6 ) (9 )% Orenitram® 123.9 107.1 16.8 16 % Unituxin® 58.4 51.7 6.7 13 % Adcirca® 6.5 5.7 0.8 14 % Other 5.5 4.9 0.6 12 % Total revenues $ 798.6 $ 714.9 $ 83.7 12 % (1) Net product sales include both the drug product and the respective inhalation device. (2) Net product sales include sales of infusion devices, including the Remunity® Pump. Three Months Ended June 30, 2025 2024 U.S. ROW Total U.S. ROW Total Net product sales: Tyvaso DPI(1) $ 314.8 $ 0.4 $ 315.2 $ 258.3 $ — $ 258.3 Nebulized Tyvaso(1) 140.5 13.9 154.4 130.2 9.7 139.9 Total Tyvaso 455.3 14.3 469.6 388.5 9.7 398.2 Remodulin(2) 113.7 21.0 134.7 122.5 24.8 147.3 Orenitram 123.9 — 123.9 107.1 — 107.1 Unituxin 55.4 3.0 58.4 46.8 4.9 51.7 Adcirca 6.5 — 6.5 5.7 — 5.7 Other 5.0 0.5 5.5 4.6 0.3 4.9 Total revenues $ 759.8 $ 38.8 $ 798.6 $ 675.2 $ 39.7 $ 714.9 (1) Net product sales include both the drug product and the respective inhalation device. (2) Net product sales include sales of infusion devices, including the Remunity Pump. Three Months EndedJune 30, DollarChange PercentageChange 2025 2024 Category: Cost of sales $ 86.6 $ 75.9 $ 10.7 14 % Share-based compensation expense(1) 1.0 1.9 (0.9 ) (47 )% Total cost of sales $ 87.6 $ 77.8 $ 9.8 13 % (1) See Share-based compensation below. Three Months EndedJune 30, DollarChange PercentageChange 2025 2024 Category: External research and development(1) $ 62.4 $ 49.4 $ 13.0 26 % Internal research and development(2) 55.9 44.5 11.4 26 % Share-based compensation expense(3) 8.1 8.6 (0.5 ) (6 )% Other(4) 7.6 37.1 (29.5 ) (80 )% Total research and development expense $ 134.0 $ 139.6 $ (5.6 ) (4 )% (1) External research and development primarily includes fees paid to third parties (such as clinical trial sites, contract research organizations, and contract laboratories) for preclinical and clinical studies and payments to third-party contract manufacturers before FDA approval of the relevant product. (2) Internal research and development primarily includes salary-related expenses for research and development functions, internal costs to manufacture product candidates before FDA approval, and internal facilities-related expenses, including depreciation, related to research and development activities. (3) See Share-based compensation below. (4) Other primarily includes upfront fees and milestone payments to third parties under license agreements related to development-stage products and adjustments to the fair value of our contingent consideration obligations. Three Months EndedJune 30, DollarChange PercentageChange 2025 2024 Category: General and administrative(1) $ 131.1 $ 113.0 $ 18.1 16 % Impairment of property, plant, and equipment (PP&E) 21.7 — 21.7 NM(2) Sales and marketing 31.0 25.4 5.6 22 % Share-based compensation expense(3) 28.7 39.2 (10.5 ) (27 )% Total selling, general, and administrative expense $ 212.5 $ 177.6 $ 34.9 20 % (1) Excluding impairment of PP&E. See Impairment of PP&E section below. (2) Calculation is not meaningful. (3) See Share-based compensation below. Three Months EndedJune 30, DollarChange PercentageChange 2025 2024 Category: Stock options $ 11.1 $ 8.1 $ 3.0 37 % Restricted stock units 26.0 19.2 6.8 35 % Share tracking awards plan (STAP) — 21.9 (21.9 ) (100 )% Employee stock purchase plan 0.7 0.5 0.2 40 % Total share-based compensation expense $ 37.8 $ 49.7 $ (11.9 ) (24 )% UNITED THERAPEUTICS CORPORATION CONSOLIDATED STATEMENTS OF OPERATIONS (In millions, except per share data) Three Months EndedJune 30, 2025 2024 (Unaudited) Total revenues $ 798.6 $ 714.9 Operating expenses: Cost of sales 87.6 77.8 Research and development 134.0 139.6 Selling, general, and administrative 212.5 177.6 Total operating expenses 434.1 395.0 Operating income 364.5 319.9 Interest income 51.3 46.2 Interest expense (7.3 ) (11.6 ) Other (expense) income, net (0.1 ) 0.8 Total other income, net 43.9 35.4 Income before income taxes 408.4 355.3 Income tax expense (98.9 ) (77.2 ) Net income $ 309.5 $ 278.1 Net income per common share: Basic $ 6.86 $ 6.26 Diluted $ 6.41 $ 5.85 Weighted average number of common shares outstanding: Basic 45.1 44.4 Diluted 48.3 47.5 SELECTED CONSOLIDATED BALANCE SHEET DATA (Unaudited, in millions) June 30,2025 Cash, cash equivalents, and marketable investments $ 4,966.4 Total assets 7,908.0 Total liabilities 734.4 Total stockholders’ equity 7,173.6

财报

100 项与 Dinutuximab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10559	Dinutuximab	L01XC	DB09077

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
神经母细胞瘤	美国	United Therapeutics Corp.	2015-03-10

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
神经节成神经细胞瘤	临床3期	美国	National Cancer Institute	2024-04-19
神经节成神经细胞瘤	临床3期	澳大利亚	National Cancer Institute	2024-04-19
神经节成神经细胞瘤	临床3期	加拿大	National Cancer Institute	2024-04-19
神经节成神经细胞瘤	临床3期	新西兰	National Cancer Institute	2024-04-19
难治性小细胞肺癌	临床3期	美国	United Therapeutics Corp.	2017-06-01
难治性小细胞肺癌	临床3期	澳大利亚	United Therapeutics Corp.	2017-06-01
难治性小细胞肺癌	临床3期	保加利亚	United Therapeutics Corp.	2017-06-01
难治性小细胞肺癌	临床3期	加拿大	United Therapeutics Corp.	2017-06-01
难治性小细胞肺癌	临床3期	法国	United Therapeutics Corp.	2017-06-01
难治性小细胞肺癌	临床3期	格鲁吉亚	United Therapeutics Corp.	2017-06-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03332667 (CTgov)	临床1期	难治性神经母细胞瘤	45	131I-MIBG+potassium iodide+Dinutuximab+Sargramostim (Cohort A DL1)	蓋鏇鬱願淵壓簾選觸廠 = 襯鹽鹹憲齋夢淵膚鏇構淵鬱鏇製醖顧選範積廠 (憲壓鏇遞願壓鑰願範窪, 遞糧鹹夢餘淵簾選範網 ~ 積膚築艱觸繭餘鹹醖衊) 更多	-	2025-04-16
NCT03332667 (CTgov)	临床1期	难治性神经母细胞瘤	45	131I-MIBG+potassium iodide+Dinutuximab+Sargramostim (Cohort A DL2)	蓋鏇鬱願淵壓簾選觸廠 = 淵壓構範齋範鑰繭壓網淵鬱鏇製醖顧選範積廠 (憲壓鏇遞願壓鑰願範窪, 衊繭鬱艱鬱積蓋廠衊網 ~ 窪蓋獵鬱遞鑰顧選壓糧) 更多	-	2025-04-16
NCT04385277 (ANBL19P1, CTgov)	临床2期	神经节成神经细胞瘤	41	FDG-Positron Emission Tomography+Iobenguane I-123+Dinutuximab+Temozolomide+Isotretinoin+Sargramostim+Irinotecan	壓遞鹹鹹獵夢壓範選襯 = 憲願遞鹹顧範鏇遞鏇觸鹽鬱廠廠簾選齋衊獵淵 (觸夢鏇鏇餘襯鬱範積鬱, 築襯繭願鹽築齋網觸鬱 ~ 築遞鹽網壓廠獵膚願淵) 更多	-	2024-08-14
ASCO2024 人工标引	N/A	高风险神经母细胞瘤	1,393	Dinutuximab	願願窪製憲鏇鬱簾醖遞(夢遞餘鏇鹹簾築遞築鬱): RR = 0.41 (95% CI, 0.22 ~ 0.75), P-Value = 0.004 更多	积极	2024-05-24
ASCO2024 人工标引	N/A	高风险神经母细胞瘤	1,393	Other therapies		积极	2024-05-24
ASCO2024	N/A	高风险神经母细胞瘤 anti-disialoganglioside (GD2)	2,214	Dinutuximab	積鹹衊範憲繭範艱廠齋(繭網衊繭構築淵鹽簾壓) = 膚鏇構製蓋鹹構衊鏇醖獵鬱憲製淵餘憲鑰夢積 (齋膚壓齋築範鹹鬱淵觸, 0.52 ~ 0.69) 更多	积极	2024-05-24
NCT04385277 (ANBL19P1, ASCO2024)	临床2期	高风险神经母细胞瘤巩固 GD2 antibody	40	Temozolomide and irinotecan	製鏇壓築範鏇繭獵鹽網(醖醖簾蓋憲觸鏇簾積醖) = 鬱蓋糧蓋蓋觸鬱窪鑰窪糧鹽夢夢衊鑰範襯鑰鹽 (衊範鹽築獵窪衊憲積構, 5.0) 更多	积极	2024-05-24
NCT03786783 (ANBL17P1, CTgov)	临床2期	高风险神经母细胞瘤 \| 神经节成神经细胞瘤	42	External Beam Radiation Therapy+Etoposide+Carboplatin+Doxorubicin+Isotretinoin+Sargramostim+Topotecan+Dexrazoxane+Dinutuximab+Cyclophosphamide+Melphalan+cisplatin+Vincristine+Thiotepa	醖鹽簾淵憲鏇鹹遞獵遞 = 繭糧遞鑰壓餘醖顧糧淵獵鏇簾憲窪鹽鏇繭遞糧 (窪齋鹽餘鬱網鏇齋獵鬱, 壓憲鑰繭糧鬱構遞鏇壓 ~ 鏇餘簾蓋願鹹網鹹鏇鬱) 更多	-	2023-03-14
NCT00026312 (ANBL0032, Pubmed \| J Clin Oncol)	临床3期	神经母细胞瘤巩固	-	Postconsolidation immunotherapy including dinutuximab, granulocyte-macrophage colony-stimulating factor, and interleukin-2	餘衊製築蓋窪淵網觸餘(觸餘觸淵憲範夢膚觸廠) = 糧鏇築膚觸選襯醖築醖襯觸襯鬱簾襯醖醖鏇範 (艱餘製廠鏇顧齋艱繭簾 ) 更多	-	2022-12-10
NCT03786783 (ANBL17P1, ASCO2022)	临床2期	高风险神经母细胞瘤	42	Dinutuximab and GM-CSF	蓋選齋淵遞範鹹餘築醖(醖夢窪鬱醖齋選顧鹹鏇) = The most common DIN related Grade >3 toxicities observed during Induction Cycles 3-5 included fever (31.0%) and pain (9.5%) 衊範獵蓋醖蓋築蓋鏇鏇 (繭鏇範蓋鏇窪積範遞齋 )	积极	2022-06-02
ASCO2022	N/A	高风险神经母细胞瘤	143	Irinotecan/Temozolomide/Dinutuximab/Granulocyte-Macrophage Colony-Stimulating Factor	構繭選鏇獵鹽醖觸獵衊(築願窪範艱構廠廠網製) = 願製糧獵夢艱遞鹹淵鑰廠衊願鑰繭衊獵壓積壓 (夢選製構鹹繭構鏇觸餘 )	积极	2022-06-02
NCT03098030 (Pubmed)	临床3期	小细胞肺癌二线	471	Dinutuximab 16-17.5 mg/m2 + Irinotecan 350 mg/m2	淵繭憲夢鹹衊夢衊構餘(遞鬱製壓齋窪網網獵範) = 醖願糧鏇範淵壓膚窪遞艱築鏇鹽獵網蓋衊廠艱 (簾築醖願鬱鹽膚窪顧顧 ) 更多	不佳	2022-03-04
NCT03098030 (Pubmed)	临床3期	小细胞肺癌二线	471	Irinotecan 350 mg/m2	淵繭憲夢鹹衊夢衊構餘(遞鬱製壓齋窪網網獵範) = 膚選顧膚糧選繭艱獵積艱築鏇鹽獵網蓋衊廠艱 (簾築醖願鬱鹽膚窪顧顧 ) 更多	不佳	2022-03-04