YORVIPATH approved by U.S. Food & Drug Administration (FDA) as the first and only treatment of hypoparathyroidism in adultsTransCon CNP (navepegritide) pivotal ApproaCH Trial topline results expected in the coming weeksSKYTROFA Q2 revenue of €26 million – 134% year-over-year volume growth offset by negative adjustment of €27 million, resetting market access for continued growthRevising full year 2024 SKYTROFA revenue outlook to €220 - €240 millionConference call today at 4:30 pm ET COPENHAGEN, Denmark, Sept ...

COPENHAGEN, Denmark, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it will report second quarter 2024 financial results and provide a business update on Tuesday, September 3, 2024, after the close of the U.S. financial markets. Ascendis Pharma will also host a conference call and live webcast on September 3, 2024, at 4:30 p.m. Eastern Time (ET) to discuss its second quarter 2024 financial results. Those who would like to participate may access the live webcast here, or ...

Shares of Ascendis Pharma A/S (ASND) were up 8.7% on Aug 13 after the company announced that the FDA had approved Yorvipath (palopegteriparatide) for the treatment of adults with hypoparathyroidism.Yorvipath (developed as TransCon PTH) is a hormone replacement therapy for treating adults with hypoparathyroidism, a rare condition in which the body produces abnormally low levels of parathyroid hormone (PTH). Low production of this hormone causes deficiencies of calcium and phosphorus compounds in the blood, r ...

Ascendis Pharma A/S (ASND) shares rallied 8.7% in the last trading session to close at $139.66. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 6.3% loss over the past four weeks.Earlier this week, the FDA approved the company’s hormone replacement therapy, Yorvipath (palopegteriparatide; developed as TransCon PTH) for the treatment of adults with hypoparathyroidism. This might have driven the share price ral ...

da-kuk Ascendis Pharma A/S (ASND), based in Copenhagen, Denmark, is a biopharmaceutical company that utilizes its proprietary TransCon technology platform to develop advanced therapeutics for endocrinology, rare diseases, and oncology. This TransCon system aims to deliver best-in-class therapies with controlled drug release, optimized effects, and less toxicity. The company’s FDA-approved product, Skytrofa, is indicated for pediatric growth hormone deficiency [GHD] and is proof of the efficacy of TransC ...

文章核心观点 - 公司的TransCon CNP(navepegritide)在1年治疗中显示了与安慰剂相比在健康状况和身体功能方面的显著改善[1][2] - 这些改善不仅仅可以解释为线性生长的变化,支持TransCon CNP可能具有超越线性生长的直接治疗效果[1][2] - TransCon CNP作为针对achondroplasia(侏儒症)健康和生活质量并发症的首个获得统计学显著改善的候选药物,有潜力满足这一需求[3] 公司概况 - 公司正在利用其创新的TransCon技术平台建立一家领先的、全面整合的生物制药公司,致力于为患者的生活带来积极影响[6] - 公司以"患者、科学和热情"为核心价值观,利用TransCon技术创造新的潜在最佳疗法[6] - 公司总部位于丹麦哥本哈根,在欧洲和美国也有其他设施[6] 临床试验情况 - ACcomplisH是一项2期、多中心、随机、双盲、安慰剂对照、剂量递增试验,评估了每周一次的TransCon CNP与安慰剂在2-10岁achondroplasia患儿中的疗效和安全性[3] - 在100μg/kg/周的剂量组,患者在日常生活功能和情感健康等方面显示出统计学显著改善,5岁及以上患者的身体功能综合评分也有显著提高[4] - 整个试验人群在100μg/kg/周剂量下52周的生长结果与随机期间该剂量组一致[4] - 未观察到新的安全信号,也未报告与研究药物相关的严重不良事件[4] - 大多数治疗期不良事件为1-2级,注射部位反应发生率较低[5]

COPENHAGEN, Denmark, June 04, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced that company executives will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference on Tuesday, June 11, 2024, at 8:00 a.m. ET in Miami, Florida. A live webcast of the fireside chat will be available via the Investors & News section of the Ascendis Pharma website at investors.ascendispharma.com. A webcast replay will also be available on this website shortly after co ...

-  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 -  45% of efficacy-evaluable patients (5 out of 11) whose disease progressed on check-point inhibitors exhibited confirmed clinical responses when treated with TransCon IL-2 β/γ as monotherapy or in combination treatment COPENHAGEN, Denmark, June 03, ...

-  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 -  45% of efficacy-evaluable patients (5 out of 11) whose disease progressed on check-point inhibitors exhibited confirmed clinical responses when treated with TransCon IL-2 β/γ as monotherapy or in combination treatment COPENHAGEN, Denmark, June 03, ...

COPENHAGEN, Denmark, May 30, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced that it will host informational booths, events, and presentations showcasing use of its innovative TransCon technology in the areas of growth hormone deficiency (GHD), hypoparathyroidism, achondroplasia, and Turner syndrome during ENDO 2024, the annual meeting of the Endocrine Society being held June 1-4, 2024, in Boston. "In addition to physician and caregiver presentations in pediatric GHD, we look forw ...