Welcome to our dedicated page for Ascendis Pharma news (Ticker: ASND), a resource for investors and traders seeking the latest updates and insights on Ascendis Pharma stock.
Ascendis Pharma A/S operates in the rare disease biotechnology sector, where news frequently centers on clinical trial results, regulatory decisions, and product commercialization milestones. The company's focus on pediatric and adult endocrine disorders means that FDA approvals, European Medicines Agency decisions, and clinical data readouts constitute particularly significant news events for investors tracking ASND.
Key news categories for Ascendis Pharma include regulatory milestones such as FDA acceptance of New Drug Applications, priority review designations, and marketing authorization decisions. Clinical trial results from pivotal studies testing the company's TransCon-based therapies provide critical insights into product viability and commercial potential. Quarterly financial reports reveal commercialization progress for approved products like SKYTROFA, including prescription trends and revenue growth in key markets.
Investors following Ascendis Pharma also monitor news about pipeline advancement, including initiation of clinical trials for new indications, enrollment progress in ongoing studies, and publication of clinical data in medical journals. Regulatory interactions, such as FDA Advisory Committee meetings or responses to Complete Response Letters, can significantly impact development timelines. Partnership announcements, manufacturing agreements, and expansion into new geographic markets represent additional news categories relevant to the company's growth strategy.
Conference presentations at major endocrinology and rare disease medical meetings often provide detailed clinical data and expert physician perspectives on Ascendis Pharma's therapies. Investor conferences and earnings calls offer management commentary on commercial execution, competitive dynamics, and strategic priorities. For a biotechnology company with multiple programs in different stages of development and commercialization, tracking this diverse news flow helps investors understand both near-term catalysts and long-term value drivers.
Ascendis Pharma has filed a Clinical Trial Notification (CTN) in Japan for the phase 3 PaTHway Japan Trial of TransCon PTH, a potential hormone replacement therapy for hypoparathyroidism. This trial aims to evaluate the safety and efficacy of TransCon PTH in adult patients, contributing to a global program for marketing authorization. The therapy addresses a significant unmet need for patients suffering from this rare endocrine disorder, affecting approximately 200,000 individuals in the U.S., Europe, Japan, and South Korea.
Ascendis Pharma (Nasdaq: ASND) reported preliminary 58-week results from the open-label extension of the PaTH Forward Trial for TransCon PTH, a treatment for hypoparathyroidism. The results show that 91% of the 58 participants were off standard care, maintaining normal urinary calcium levels and experiencing improved quality of life. TransCon PTH was well-tolerated, with no serious adverse events reported. Ascendis plans to conduct a phase 3 trial in Japan and expects topline results from a related study in Q4 2021.
Ascendis Pharma A/S (Nasdaq: ASND) announced the presentation of data for TransCon PTH at two medical conferences. The 48th annual meeting of the European Calcified Tissue Society is set for May 6-8, 2021, followed by the 23rd European Congress of Endocrinology from May 22-26, 2021. The results from the PaTH Forward Trial suggest that TransCon PTH may serve as a first-line hormone replacement therapy for hypoparathyroidism. Oral presentations at both conferences highlight the significance of these findings, which could impact treatment options in endocrinology.
Ascendis Pharma A/S (Nasdaq: ASND) announced its participation in the BofA Securities 2021 Virtual Health Care Conference on May 11, 2021. Company executives will present a business overview and update on its pipeline programs. The event will be held virtually at 4:15 p.m. Eastern Time. A live audio webcast will be accessible on the Company’s website and will be available for replay for 30 days post-event. Ascendis Pharma focuses on utilizing its TransCon technologies to develop therapies for unmet medical needs, currently featuring a pipeline in endocrinology and oncology.
Ascendis Pharma A/S (Nasdaq: ASND) has announced presentations featuring TransCon hGH (lonapegsomatropin) at two medical conferences: Pediatric Endocrinology Nursing Society (PENS) from April 21-23 and Pediatric Endocrine Society (PES) from April 30-May 3, 2021. The company will present two-year follow-up data on the efficacy and safety of lonapegsomatropin in children with growth hormone deficiency (GHD), alongside a model for estimating average IGF-1 levels. The presentations aim to support healthcare providers in managing patients post-regulatory approval.
Ascendis Pharma A/S (Nasdaq: ASND) announced participation in the J.P. Morgan 10th Annual Napa Valley Biotech Forum on March 30, 2021, at 4:00 p.m. ET. The forum will be virtual, allowing company executives to present a business overview and updates on their pipeline programs. The event underscores Ascendis' commitment to expanding its portfolio of rare disease and oncology product candidates using its innovative TransCon technologies. A live audio webcast will be available on the company’s website, with a replay accessible for 30 days post-event.
Ascendis Pharma A/S presented promising data on TransCon PTH at the Endocrine Society's annual meeting, highlighting its potential as a hormone replacement therapy for adults with hypoparathyroidism. In a six-month open-label extension of the Phase 2 PaTH Forward Trial, over 90% of 58 subjects achieved independence from conventional treatments, while maintaining normal serum calcium levels. Notably, patient-reported outcomes improved significantly. TransCon PTH remains well-tolerated without serious adverse events. Upcoming PaTHway Trial phase 3 data is expected in Q4 2021, aiming to further assess safety and efficacy.
Ascendis Pharma A/S (Nasdaq: ASND) announced its participation in the Oppenheimer 31st Annual Healthcare Conference on March 17, 2021, at 11:20 a.m. Eastern Time. The virtual event will feature company executives providing a business overview and updates on its pipeline programs. Ascendis Pharma develops innovative therapies using its TransCon technologies, focusing on endocrinology and oncology. The company continues to expand its product pipeline, which includes three endocrinology rare disease candidates and one oncology candidate in clinical development.
Ascendis Pharma A/S (ASND) announced financial results for 2020, showing a net loss of €419.0 million, or €8.28 per share, compared to €218.0 million in 2019. Revenue decreased to €7.0 million from €13.4 million. R&D expenses rose to €260.9 million, driven by personnel costs and facility expansion. Cash reserves improved to €834.1 million from €598.1 million. Key milestones include preparations for launching TransCon hGH in the U.S. in Q3 2021 and ongoing clinical trials for several product candidates, with important regulatory updates expected in 2021.
Ascendis Pharma A/S (Nasdaq: ASND) announced its participation in ENDO 2021, showcasing seven presentations on its innovative TransCon™ technologies. Key highlights include the first presentation of 6-month data from the phase 2 PaTH Forward trial for adult hypoparathyroidism, demonstrating the potential of TransCon PTH in reducing standard care treatments while maintaining normal serum calcium. Additionally, two-year follow-up data for TransCon hGH (lonapegsomatropin) shows durable results in children with growth hormone deficiency. The presentations will address significant advancements in endocrinology.
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