更新于：2024-09-05
Lonapegsomatropin-tcgd
隆培促生长素
更新于：2024-09-05
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2021-08-25), |
最高研发阶段(中国)申请上市 |
特殊审评孤儿药 (美国)、孤儿药 (欧盟) |
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序列信息
Sequence Code 26401985
来源: *****
关联
16
项与 隆培促生长素 相关的临床试验COACH: A Phase 2, Open-Label, Single-Arm, 156-week Trial to Investigate the Efficacy, Safety and Tolerability of Combined Once Weekly Navepegritide and Lonapegsomatropin in Children with Achondroplasia - ASND0042
开始日期2024-07-26 |
A Phase 2, Open-Label, Single-Arm, 156-week Trial to Investigate the Efficacy, Safety and Tolerability of Combined Once Weekly Navepegritide and Lonapegsomatropin in Children With Achondroplasia
This proof-of-concept trial is being conducted to evaluate the efficacy, safety and tolerability of combination treatment with navepegritide and lonapegsomatropin administered as separate subcutaneous (SC) injections once weekly in children with achondroplasia (ACH) aged 2 to 11 years.
开始日期2024-07-26 |
A Prospective, Non-interventional (NIS), Long-term, Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin
The goal of this study is to further characterise the potential long-term safety risks of lonapegsomatropin in patients treated with lonapegsomatropin under real-world conditions in the post-marketing setting.
开始日期2023-03-20 |
100 项与 隆培促生长素 相关的临床结果
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100 项与 隆培促生长素 相关的转化医学
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100 项与 隆培促生长素 相关的专利（医药）
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37
项与 隆培促生长素 相关的文献（医药）2023-01-01·Hormone research in paediatrics
Weekly Growth Hormone (Lonapegsomatropin) Causes Severe Transient Hyperglycemia in a Child with Obesity
作者: Estrada, Doris Elizabeth ; Majidi, Shideh ; Dauber, Andrew ; Alkhatib, Einas H
Introduction: A 12-year-and-9-month-old non-Hispanic black male with a history of growth hormone deficiency, pituitary hypoplasia, prediabetes, obesity, hypertension, and hyperlipidemia was initiated on weekly growth hormone (lonapegsomatropin-tcgd) and then transiently developed symptomatic hyperglycemia to 500 mg/dL. We aimed to describe this medication’s effect. Case Presentation: He was born full term and appropriate for gestational age. He was referred to endocrinology at 3.5 years of age for short stature with a height SDS of −2.48. IGF-1 51.1 ng/mL and IGFBP-3 1.2 ng/mL were low. GH stimulation test noted baseline and peak GH of 0.1 ng/mL. MRI brain showed hypoplastic adenohypophysis, aplastic pituitary stalk, and ectopic neurohypophysis. There had been difficulty with adherence to daily GH over the following 9 years. BMI trajectory rose above 180% of the 95th percentile. By age 12, A1c was 6.6%. Metformin was started and increased to 1,000 mg twice daily. Subsequent A1c was 6.0%. Due to poor compliance with daily GH, at 12 years and 9 months, he was initiated on 22 mg (0.25 mg/kg/week) of weekly lonapegsomatropin-tcgd to improve compliance. The day after his first injection, he developed non-bloody, non-bilious emesis. He denied headaches and endorsed polyuria. Due to concern for increased intracranial pressure, he was sent to the emergency department; however, ophthalmologic exam was negative. Initial serum glucose was 500 mg/dL, then 336 mg/dL after 1-L normal saline. Hemoglobin A1c was 5.7%, urine glucose 3+ mg/dL, and urine ketones 2+ mg/dL. Venous pH of 7.379 and bicarbonate of 20.6 mmol/L ruled out diabetic ketoacidosis. Metformin was held during the hospitalization. Hyperglycemia rapidly improved with transient insulin administration. He received one dose of glargine 20 units. He was initiated on lispro carb ratio of 1:8 and correction factor 1:15 for target glucose 150 mg/dL. By day four, glucoses were below 100 mg/dL; lispro was discontinued, and he was discharged home. Weekly GH was discontinued with plans to resume daily GH therapy in several months. Conclusion: Lonapegsomatropin-tcgd offers the convenience of weekly rather than daily GH treatment; however, this patient developed a rapid increase in insulin resistance and hyperglycemia requiring insulin. The discrepancy between the glucose of 500 mg/dL and A1c of 5.7%, along with the rapid resolution of hyperglycemia, is further consistent with a medication side effect. Close glucose monitoring of patients initiated on weekly growth hormone is crucial, particularly in those with a history of prediabetes.
2022-06-16·The Journal of clinical endocrinology and metabolism2区 · 医学
Safety and Efficacy of Lonapegsomatropin in Children With Growth Hormone Deficiency: enliGHten Trial 2-Year Results
2区 · 医学
Article
作者: Saenger, Paul ; Hofman, Paul L ; Mygind, Per Holse ; Song, Wenjie ; Aghajanova, Elena M ; Maniatis, Aristides K ; Chessler, Steven D ; Malievskiy, Oleg ; Nadgir, Ulhas M ; Mao, Meng ; Beckert, Michael ; Korpal-Szczyrska, Maria ; Chertock, Elena D ; Thornton, Paul S ; Shu, Aimee D ; Vlachopapadopoulou, Elpis ; Smith, Alden R ; Komirenko, Allison S ; Cappa, Marco ; Casella, Samuel J ; Chaychenko, Tetyana
Abstract:
Purpose:
The objectives of the ongoing, Phase 3, open-label extension trial enliGHten are to assess the long-term safety and efficacy of weekly administered long-acting growth hormone lonapegsomatropin in children with growth hormone deficiency.
Methods:
Eligible subjects completing a prior Phase 3 lonapegsomatropin parent trial (heiGHt or fliGHt) were invited to participate. All subjects were treated with lonapegsomatropin. Subjects in the United States switched to the TransCon hGH Auto-Injector when available. Endpoints were long-term safety, annualized height velocity, pharmacodynamics [insulin-like growth factor-1 SD score (SDS) values], and patient- and caregiver-reported assessments of convenience and tolerability.
Results:
Lonapegsomatropin treatment during enliGHten was associated with continued improvements in height SDS through week 104 in treatment-naïve subjects from the heiGHt trial (−2.89 to −1.37 for the lonapegsomatropin group; −3.0 to −1.52 for the daily somatropin group). Height SDS also continued to improve among switch subjects from the fliGHt trial (−1.42 at fliGHt baseline to −0.69 at week 78). After 104 weeks, the average bone age/chronological age ratio for each treatment group was 0.8 (0.1), showing only minimal advancement of bone age relative to chronological age with continued lonapegsomatropin treatment among heiGHt subjects. Fewer local tolerability reactions were reported with the TransCon hGH Auto-Injector compared with syringe/needle.
Conclusions:
Treatment with lonapegsomatropin continued to be safe and well-tolerated, with no new safety signals identified. Children treated with once-weekly lonapegsomatropin showed continued improvement of height SDS through the second year of therapy without excess advancement of bone age.
2022-04-19·The Journal of clinical endocrinology and metabolism2区 · 医学
Response to Letter to the Editor From Malozowski: “Weekly Lonapegsomatropin in Treatment-Naïve Children With Growth Hormone Deficiency: The Phase 3 heiGHt Trial”
2区 · 医学
Letter
作者: Karpf, David B ; Giorgadze, Elene ; Christoffersen, Eva Dam ; Maniatis, Aristides K ; Thornton, Paul S ; Breinholt, Vibeke Miller ; Korpal-Szczyrska, Maria ; Song, Wenjie ; Hofman, Paul L ; Beckert, Michael ; Chertok, Elena ; Lin, Zhengning ; Aghajanova, Elena ; Shu, Aimee D
128
项与 隆培促生长素 相关的新闻（医药）2024-09-05
·药研网
9月5日，诺和诺德长效生长激素帕西生长素注射液的上市申请获得NMPA受理。
Somapacitan最初于2020年9月1日获FDA批准用于治疗成人生长激素缺乏症。2023年4月，FDA扩大了somapacitan的适应症，用于治疗2.5岁及以上儿童的生长激素缺乏症。
在一项评估somapacitan治疗青春期前儿童生长激素缺乏症的疗效与安全性的REAL4研究中，研究数据表明，接受每周一次somapacitan治疗的患者年化生长高度为11.2cm/年，与接受每日一次Norditropin治疗的患者年化生长高度为11.7cm/年相比没有显著差异，达到了非劣效的主要终点。此外，somapacitan耐受性良好，具有与Norditropin相似的安全性和耐受性。
目前，FDA累计批准3款长效生长激素，包括诺和诺德的Sogroya（帕西生长素）、Ascendis的Skytrofa（隆培促生长素）、辉瑞/OPKO的Ngenla（somatrogon）。
临床结果
2024-09-05
·医药笔记
▎Armstrong
2024年9月5日，诺和诺德长效生长激素帕西生长素注射液的上市申请获得NMPA受理。
FDA累计批准3款长效生长激素，包括诺和诺德的Sogroya（帕西生长素）、Ascendis的Skytrofa（隆培促生长素）、辉瑞/OPKO的Ngenla（somatrogon）。诺和诺德在全球生长激素市场份额为19%，2023年销售额为5.7亿美元。国产品种方面，仅长春高新的金赛增获批上市。
帕西生长素在三期临床中非劣效于短效生长激素。
总结
2023年，中国生长激素市场规模超过130亿元人民币，长春高新占据领导地位，其次为安科生物。长效生长激素上市时间较短，目前市场份额在30%左右，但处于快速增长阶段，预计未来长效生长激素将成为主流。
Armstrong技术全梳理系列
GPRC5D靶点全梳理；
CD40靶点全梳理；
CD47靶点全梳理；
补体靶向药物技术全梳理；
补体药物：眼科治疗的重要方向；
Claudin 6靶点全梳理；
Claudin 18.2靶点全梳理；
靶点冷暖，行业自知；
中国大分子新药研发格局；
被炮轰的“me too”；
佐剂百年史；
胰岛素百年传奇；
CUSBEA：风雨四十载；
中国新药研发的焦虑；
中国生物医药企业的研发竞争；
中国双抗竞争格局；
中国ADC竞争格局；
中国双抗技术全梳理；
中国ADC技术全梳理；
Ambrx技术全梳理；
Vir Biotech技术全梳理；
Immune-Onc技术全梳理；
亘喜生物技术全梳理；
康哲药业技术全梳理；
科济药业技术全梳理；
恺佧生物技术全梳理；
同宜医药技术全梳理；
百奥赛图技术全梳理；
腾盛博药技术全梳理；
创胜集团技术全梳理；
永泰生物技术全梳理；
中国抗体技术全梳理；
德琪医药技术全梳理；
德琪医药技术全梳理2.0；
和铂医药技术全梳理；
荣昌生物技术全梳理；
再鼎医药技术全梳理；
药明生物技术全梳理；
恒瑞医药技术全梳理；
豪森药业技术全梳理；
正大天晴技术全梳理；
吉凯基因技术全梳理；
基石药业技术全梳理；
百济神州技术全梳理；
百济神州技术全梳理第2版；
信达生物技术全梳理；
信达生物技术全梳理第2版；
中山康方技术全梳理；
复宏汉霖技术全梳理；
先声药业技术全梳理；
君实生物技术全梳理；
嘉和生物技术全梳理；
志道生物技术全梳理；
道尔生物技术全梳理；
尚健生物技术全梳理；
康宁杰瑞技术全梳理；
科望医药技术全梳理；
科望医药技术全梳理2.0；
岸迈生物技术全梳理；
礼进生物技术全梳理；
康桥资本技术全梳理；
余国良的抗体药布局；
荃信生物技术全梳理；
安源医药技术全梳理；
三生国健技术全梳理；
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乐普生物技术全梳理；
同润生物技术全梳理；
宜明昂科技术全梳理；
派格生物技术全梳理；
迈威生物技术全梳理；
Momenta技术全梳理；
NGM技术全梳理；
普米斯生物技术全梳理；
普米斯生物技术全梳理2.0；
三叶草生物技术全梳理；
贝达药业抗体药全梳理；
泽璟制药抗体药全梳理；
恒瑞医药抗体药全梳理；
齐鲁制药抗体药全梳理；
石药集团抗体药全梳理；
豪森药业抗体药全梳理；
华海药业抗体药全梳理；
科伦药业抗体药全梳理；
百奥泰技术全梳理；
凡恩世技术全梳理。
抗体药物偶联物临床3期医药出海引进/卖出申请上市
2024-09-03
YORVIPATH approved by U.S. Food & Drug Administration (FDA) as the first and only treatment of hypoparathyroidism in adults
TransCon CNP (navepegritide) pivotal ApproaCH Trial topline results expected in the coming weeks
SKYTROFA Q2 revenue of €26 million – 134% year-over-year volume growth offset by negative adjustment of €27 million, resetting market access for continued growth
Revising full year 2024 SKYTROFA revenue outlook to €220
-
€240 million
Conference call today at 4:30 pm ET
COPENHAGEN, Denmark, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced financial results for the second quarter ended June 30, 2024, and provided a business update.
“The recent FDA approval of YORVIPATH demonstrates why our unrelenting focus on helping patients suffering from hypoparathyroidism and other serious diseases with considerable unmet need is so important for Ascendis,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. “Already, two out of our three Endocrine Rare Disease TransCon product candidates have been approved by the FDA and European Commission. Our first, SKYTROFA, has achieved U.S. market value leadership, and, we believe, now with broader market access, remains well positioned to reach blockbuster status in the U.S. alone. Looking forward, we are preparing for our second U.S. launch with YORVIPATH and are on track to report pivotal data in the coming weeks for our third TransCon product candidate, TransCon CNP.”
Select Highlights & Anticipated 2024 Milestones
TransCon hGH:
(lonapegsomatropin, marketed as SKYTROFA)
SKYTROFA revenue for the second quarter of 2024 totaled €26.2 million, a 27% year-over-year decrease compared to €35.9 million during the same period in 2023. 134% year-over-year volume growth was offset by the cost associated with broader market access for SKYTROFA which also resulted in a negative adjustment to prior period sales deductions of €27.1 million, where €19.5 million and €7.6 million were attributable to the three months ended March 31, 2024, and periods prior to January 1, 2024, respectively.
SKYTROFA revenue for the first half of 2024 totaled €91.2 million, a 35% year-over-year increase compared to €67.4 million during the same period of 2023. 159% year-over-year volume growth was offset by the cost associated with broader market access for SKYTROFA which also resulted in a negative adjustment to prior period sales deductions of €7.6 million, which were attributable to periods prior to January 1, 2024.
On track to submit a supplemental Biologics License Application to the FDA for adult growth hormone deficiency in the third quarter of 2024.
Topline results from Phase 2 New InsiGHTS Trial in Turner syndrome expected in the fourth quarter of 2024.
TransCon PTH:
(palopegteriparatide, marketed as YORVIPATH)
Received U.S. FDA approval for TransCon PTH, under the brand name YORVIPATH, for the treatment of hypoparathyroidism in adults.
Completing manufacturing of commercial product for the U.S. market and anticipate initial supply will be available in the first quarter of 2025. The Company is in dialogue with the FDA about commercialization of existing manufactured product, which if agreed, could be introduced in the U.S. in the fourth quarter of 2024.
Second quarter YORVIPATH revenue totaled €5.2 million, reflecting the first full quarter of commercial launch in Germany and Austria as well initial revenue in International Markets. Initial revenue in France expected starting in the fourth quarter of 2024.
TransCon CNP
(navepegritide)
Topline data from pivotal ApproaCH Trial expected in the coming weeks, and, if successful, plan to submit a New Drug Application to FDA for children with achondroplasia (age 2-11 years) in the first quarter of 2025.
Plan to complete enrollment in the combination TransCon hGH and TransCon CNP COACH trial of children with achondroplasia (ages 2-11 years) during the third quarter of 2024; topline Week 26 data expected in the second quarter of 2025.
Expect to initiate teACH, a Phase 2 trial in adolescents with achondroplasia, in the fourth quarter of 2024.
Oncology Programs
Presented new and updated results from the ongoing Phase 1/2 IL-Believe Trial of TransCon IL-2 β⁄γ in a poster presentation at ASCO 2024. As of the April 16, 2024, data cutoff, 40% of efficacy-evaluable patients (2 out of 5) in the initial cohort of patients with anti-PD-1 refractory melanoma treated with TransCon IL-2 β⁄γ in combination with TransCon TLR7/8 Agonist exhibited confirmed clinical responses with no new safety signals.
Initial results from the Phase 2 dose expansion cohort of the IL-Believe Trial of TransCon IL-2 β⁄γ in combination with chemotherapy in platinum-resistant ovarian cancer (PROC) will be presented later this month at the European Society for Medical Oncology (ESMO) 2024 Congress in Barcelona, Spain.
Financial Update and Outlook Based on Current Plans
As of June 30, 2024, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling €259 million, compared to €399 million as of December 31, 2023.
Full year 2024 SKYTROFA revenue expected to be €220 million to €240 million.
Expect total operating expenses (SG&A and R&D) to be approximately €600 million for 2024.
Pending launch timing of YORVIPATH in the U.S., expect to be operating cash flow breakeven on a quarterly basis in 2024 or 2025
Subsequent to the quarter end, entered into a $150 million capped synthetic royalty funding agreement with Royalty Pharma relating to net sales of YORVIPATH in the United States. More information on this funding can be found in a separate press release issued today and available
here
on the Investors & News section of the Ascendis Pharma website.
Second Quarter 2024 Financial Results
Total revenue for the second quarter of 2024 was €36.0 million, compared to €47.4 million during the same period for 2023. Results in the quarter were primarily impacted by a negative adjustment to prior periods’ estimates and assumptions for sales deductions of €27.1 million, where €19.5 million and €7.6 million were attributable to the three months ended March 31, 2024, and periods prior to January 1, 2024, respectively. This was partially offset by increased demand for SKYTROFA in the U.S. and revenue contribution from YORVIPATH. In addition, non-product revenue was €4.6 million in the second quarter of 2024, compared to €11.5 million during the same period for 2023.
Total Revenue
(In EUR'000s)
Three Months Ended
June 30,
Six Months Ended
June 30,
2024
2023
2024
2023
Revenue from external customers
Commercial sale of products
31,389
35,895
97,888
67,446
Licenses
869
589
25,639
1,203
Other
3,740
10,909
8,365
12,333
Total revenue from external customers
35,998
47,393
131,892
80,982
Research and development (R&D) costs for the second quarter of 2024 were €83.5 million, compared to €105.0 million during the same period in 2023. The decline was largely tied to lower external development costs for TransCon TLR 7/8 Agonist and lower costs for TransCon PTH, as well as lower employee costs as a result of the Eyconis spin-off.
Selling, general, and administrative (SG&A) expenses for the second quarter of 2024 were €74.3 million, compared to €70.3 million during the same period in 2023. The increase was primarily due to higher employee costs, including the impact from commercial expansion.
Total operating expenses for the second quarter of 2024 were €157.8 million compared to €175.3 million during the same period in 2023.
Net finance income for the second quarter of 2024 was €29.4 million compared to a net finance income of €26.4 million during the same period in 2023.
For the second quarter of 2024, Ascendis Pharma reported a net loss of €109.4 million, or €1.91 per share (basic and diluted) compared to a net loss of €121.4 million, or €2.16 per share (basic and diluted) for the same period in 2023.
As of June 30, 2024, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling €258.7 million compared to €399.4 million as of December 31, 2023. As of June 30, 2024, Ascendis Pharma had 58,231,484 ordinary shares outstanding, including 881,730 ordinary shares represented by ADSs held by the company.
Conference Call and Webcast Information
Ascendis Pharma will host a conference call and webcast today at 4:30 pm Eastern Time (ET) to discuss its second quarter 2024 financial results.
Those who would like to participate may access the live webcast
here
, or register in advance for the teleconference
here
. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at A replay of the webcast will be available on this section of the Ascendis Pharma website shortly after conclusion of the event for 30 days.
About Ascendis Pharma A/S
Ascendis Pharma is applying its innovative TransCon technology platform to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of Patients, Science, and Passion, Ascendis uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Europe and the United States. Please visit
ascendispharma.com
to learn more.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) the timing of topline results from the ApproaCH Trial, (ii) Ascendis’ expectations regarding full year 2024 SKYTROFA revenue, (iii) Ascendis’ expectations regarding SKYTROFA’s potential to reach blockbuster status, (iv) Ascendis’ plan to submit a supplemental Biologics License Application for SKYTROFA for adult growth hormone deficiency in the third quarter of 2024, (v) the timing of topline results from the Phase 2 trial of TransCon hGH in Turner syndrome, (vi) Ascendis’ plan to submit a New Drug Application for TransCon CNP for children with achondroplasia, (vii) Ascendis’ expectations regarding completing manufacturing of YORVIPATH commercial product for the U.S. market and the timing of initial supply, (viii) dialogue with FDA regarding commercialization of existing YORVIPATH manufactured product and, if agreed, the potential timing of introduction, (ix) Ascendis’ expectations regarding initial revenue in France from YORVIPATH, (x) Ascendis’ plan to complete enrollment in the COACH Trial, (xi) the timing of topline Week 26 data from the COACH Trial, (xii) the timing of initiating the teACH Phase 2 trial in adolescents, (xiii) Ascendis’ plan to present initial results from the Phase 2 dose expansion cohort of the IL-Believe Trial, (xiv) Ascendis’ expectations regarding its total operating expenses for 2024, (xv) Ascendis’ expectation to be operating cash flow breakeven on a quarterly basis in 2024 or 2025, (xvi) Ascendis’ ability to apply its TransCon technology platform to build a leading, fully integrated biopharma company, and (xvii) Ascendis’ use of its TransCon technologies to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on third party manufacturers, distributors and service providers for Ascendis’ products and product candidates; unforeseen safety or efficacy results in Ascendis’ development programs or on-market products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis’ development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis’ business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; the impact of international economic, political, legal, compliance, social and business factors. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 7, 2024 and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.
Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, TransCon, SKYTROFA
®
, and YORVIPATH
®
are trademarks owned by the Ascendis Pharma group. © September 2024 Ascendis Pharma A/S.
Investor Contacts:
Media Contact:
Tim Lee
Melinda Baker
Ascendis Pharma
Ascendis Pharma
+1 (650) 374-6343
+1 (650) 709-8875
tle@ascendispharma.com
media@ascendispharma.com
ir@ascendispharma.com
Patti Bank
ICR Westwicke
+1 (415) 513-1284
patti.bank@westwicke.com
FINANCIAL TABLES FOLLOW
Ascendis Pharma A/S
Consolidated Statements of Profit or Loss and Comprehensive Income / (Loss)
(In EUR'000s, except share and per share data)
Three Months Ended
June 30,
Six Months Ended
June 30,
2024
2023
2024
2023
Consolidated Statement of Profit or Loss
Revenue
35,998
47,393
131,892
80,982
Cost of sales
11,465
12,929
19,034
17,551
Gross profit
24,533
34,464
112,858
63,431
Research and development costs
83,478
105,021
154,165
211,134
Selling, general and administrative expenses
74,312
70,281
141,095
136,820
Operating profit/(loss)
(133,257
)
(140,838
)
(182,402
)
(284,523
)
Share of profit/(loss) of associate
(5,322
)
(7,451
)
(11,118
)
(8,677
)
Finance income
49,052
35,761
14,395
80,374
Finance expenses
19,624
9,334
58,553
18,652
Profit/(loss) before tax
(109,151
)
(121,862
)
(237,678
)
(231,478
)
Income taxes/(expenses)
(229
)
429
(2,737
)
(868
)
Net profit/(loss) for the period
(109,380
)
(121,433
)
(240,415
)
(232,346
)
Attributable to owners of the Company
(109,380
)
(121,433
)
(240,415
)
(232,346
)
Basic and diluted earnings/(loss) per share
€
(1.91
)
€
(2.16
)
€
(4.21
)
€
(4.14
)
Number of shares used for calculation (basic and diluted)
57,345,613
56,218,257
57,114,435
56,155,441
(EUR’000)
Consolidated Statement of Comprehensive Income or (Loss)
Net profit/(loss) for the period
(109,380
)
(121,433
)
(240,415
)
(232,346
)
Items that may be reclassified subsequently to profit or loss:
Exchange differences on translating foreign operations
15
(1,016
)
78
(1,803
)
Other comprehensive income/(loss) for the period, net of tax
15
(1,016
)
78
(1,803
)
Total comprehensive income/(loss) for the period, net of tax
(109,365
)
(122,449
)
(240,337
)
(234,149
)
Attributable to owners of the Company
(109,365
)
(122,449
)
(240,337
)
(234,149
)
Ascendis Pharma A/S
Consolidated Statements of Financial Position
(In EUR'000s)
June 30, 2024
December 31, 2023
Assets
Non-current assets
Intangible assets
4,186
4,419
Property, plant and equipment
104,041
110,634
Investment in associates
20,564
5,686
Other receivables
2,186
2,127
130,977
122,866
Current assets
Inventories
251,199
208,931
Trade receivables
49,163
35,874
Income tax receivables
1,841
802
Other receivables
29,679
19,097
Prepayments
36,743
38,578
Marketable securities
—
7,275
Cash and cash equivalents
258,696
392,164
627,321
702,721
Total assets
758,298
825,587
Equity and liabilities
Equity
Share capital
7,819
7,749
Distributable equity
(328,952
)
(153,446
)
Total equity
(321,133
)
(145,697
)
Non-current liabilities
Borrowings
219,052
222,996
Contract liabilities
5,000
5,949
Deferred tax liabilities
7,644
5,830
231,696
234,775
Current liabilities
Convertible notes, matures in April 2028
Borrowings
432,190
407,095
Derivative liabilities
159,059
143,296
591,249
550,391
Other current liabilities
Borrowings
21,397
14,174
Contract liabilities
1,293
1,184
Trade payables and accrued expenses
99,527
94,566
Other liabilities
26,411
41,176
Income tax payables
1,090
2,299
Provisions
106,768
32,719
256,486
186,118
847,735
736,509
Total liabilities
1,079,431
971,284
Total equity and liabilities
758,298
825,587
临床2期上市批准临床结果财报
100 项与 隆培促生长素 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 生长激素缺乏症 | 美国 | 2021-08-25 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 垂体性侏儒症 | 临床3期 | 中国 | 2019-12-30 | |
| 激素缺乏症 | 临床3期 | 加拿大 | 2017-11-13 | |
| 软骨发育不全 | 临床2期 | 丹麦 | 2024-07-26 | |
| 软骨发育不全 | 临床2期 | 爱尔兰 | 2024-07-26 | |
| 软骨发育不全 | 临床2期 | 英国 | 2024-07-26 | |
| 特纳综合症 | 临床2期 | 美国 | - |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床3期 | 298 | 積獵選顧願願窪糧鏇選(遞範範積窪襯構膚簾壓) = 糧顧願築鹽憲鹽積構顧 憲構蓋獵選顧鹽繭膚網 (衊壓積築繭廠窪餘壓夢, 襯鑰壓遞獵範繭積觸願 ~ 構憲齋積繭遞糧齋願鹹) 更多 | - | 2024-05-08 | |||
临床3期 | 259 | 鏇憲壓範鏇醖積範餘艱(鏇範鹹夢製鑰鹽製遞鏇) = 遞艱醖遞範製製鏇憲網 壓壓範齋鹹齋窪蓋鏇蓋 (窪糧鑰製積齋醖獵窪鹽 ) 更多 | 积极 | 2023-12-19 | |||
Placebo | 鏇憲壓範鏇醖積範餘艱(鏇範鹹夢製鑰鹽製遞鏇) = 觸觸齋鑰鹽淵網觸選廠 壓壓範齋鹹齋窪蓋鏇蓋 (窪糧鑰製積齋醖獵窪鹽 ) 更多 | ||||||
N/A | 81 | 範艱選鏇顧醖餘網醖築(網繭願齋壓選鹽獵蓋齋) = The most commonly reported adverse events over the course of the trial were categorized as infections, injury, and respiratory/thoracic/medical disorders. The majority of adverse events were mild in severity and unrelated to treatment. No adverse events led to discontinuation of the study treatment. 遞醖淵構繭願鹽網蓋積 (衊夢餘醖製顧壓鏇繭鑰 ) | 积极 | 2023-09-23 | |||
(at the beginning of the open-label extension trial) | |||||||
临床3期 | 298 | 網夢壓觸糧夢窪廠蓋糧(鏇選夢願糧簾網築選願) = 獵齋製願簾餘壓鑰網餘 鹹淵製顧襯壓繭齋醖鹽 (壓鏇壓簾願構膚鬱鏇齋, 6) | - | 2023-09-21 | |||
临床3期 | 150 | (Longpei growth promoting hormone group) | 壓築糧鹹範願鏇構觸膚(鹽淵襯獵醖膚遞鏇廠鬱) = 築淵淵鏇鏇鬱壓願餘艱 鑰餘壓餘蓋齋積製範襯 (憲廠觸壓蓋觸積願餘鏇 ) | 积极 | 2022-11-17 | ||
(growth hormone daily preparation group) | 壓築糧鹹範願鏇構觸膚(鹽淵襯獵醖膚遞鏇廠鬱) = 艱鑰範鹽網選鏇簾蓋憲 鑰餘壓餘蓋齋積製範襯 (憲廠觸壓蓋觸積願餘鏇 ) | ||||||
临床3期 | 146 | 憲選壓選製醖淵觸窪鹽(憲鬱選夢鑰鬱襯獵艱窪) = 獵衊鹽夢廠夢餘製製觸 願觸遞蓋壓淵餘網蓋鹹 (夢網築積獵範簾夢鹹製, 餘遞選艱願簾蓋製憲蓋 ~ 鏇糧糧觸築壓鑰鏇觸簾) 更多 | - | 2022-01-04 | |||
临床2期 | 53 | 衊鑰膚範衊壓蓋構遞顧(糧獵蓋願鏇積遞獵衊築) = 憲選艱鬱構積廠淵顧鏇 壓廠艱壓構餘遞淵鑰構 (糧網蓋蓋鹹淵簾築醖餘 ) | 积极 | 2017-05-01 | |||
Genotropin | 衊鑰膚範衊壓蓋構遞顧(糧獵蓋願鏇積遞獵衊築) = 簾襯獵顧窪淵鹹醖蓋製 壓廠艱壓構餘遞淵鑰構 (糧網蓋蓋鹹淵簾築醖餘 ) | ||||||
临床2期 | 37 | (ACP-001, 0.02 mg hGH/kg/wk) | 蓋憲觸網壓壓遞鏇製廠(窪遞廠築範顧窪鹽簾範) = 齋願鹹膚鏇糧鹽蓋築鹽 夢壓觸簾淵憲願壓選壓 (糧艱網觸憲餘襯窪鬱鑰, 顧餘鹹醖繭艱願餘衊鏇 ~ 膚鬱製鹹鏇鬱齋淵範蓋) 更多 | - | 2017-03-09 | ||
(ACP-001, 0.04 mg hGH/kg/wk) | 蓋憲觸網壓壓遞鏇製廠(窪遞廠築範顧窪鹽簾範) = 鹽鹹鹽膚鬱醖構構壓獵 夢壓觸簾淵憲願壓選壓 (糧艱網觸憲餘襯窪鬱鑰, 壓鏇壓鏇餘獵鹽蓋遞蓋 ~ 簾鹹膚觸積鏇鬱製鹽膚) 更多 | ||||||
临床2期 | 53 | (ACP-001, Dose-level 1) | 蓋艱窪簾淵簾鏇膚襯衊(鏇窪鬱襯襯淵憲簾艱鏇) = 艱醖獵壓遞鹹廠齋醖夢 鬱襯蓋壓顧獵襯製鏇製 (膚糧繭糧膚膚積鑰艱獵, 願鑰鹹鏇糧鏇遞顧襯鏇 ~ 選膚鏇網鑰衊觸製遞鹹) 更多 | - | 2017-01-19 | ||
(ACP-001, Dose-level 2) | 蓋艱窪簾淵簾鏇膚襯衊(鏇窪鬱襯襯淵憲簾艱鏇) = 製鏇願憲鬱繭網醖鬱獵 鬱襯蓋壓顧獵襯製鏇製 (膚糧繭糧膚膚積鑰艱獵, 鏇鑰醖觸簾繭獵壓壓夢 ~ 遞衊鑰鑰淵衊範範餘襯) 更多 | ||||||
临床2期 | - | 53 | TransCon hGH 0.14 mg/kg per week | 壓醖簾觸鏇範鹹衊夢餘(憲鏇餘構獵衊遞膚鑰壓) = 夢鹽繭餘觸廠製顧窪鬱 餘鹽鬱積選網製鹹窪鏇 (繭齋範獵醖獵觸餘願襯 ) | 积极 | 2016-09-10 |
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