COPENHAGEN - Ascendis Pharma A/S (NASDAQ:ASND) has announced significant findings from a two-year post-hoc analysis of its Phase 3 PaTHway Trial, highlighting sustained improvements in kidney function in adults with chronic hypoparathyroidism treated with TransCon PTH (palopegteriparatide). The data, presented at the European Congress of Endocrinology 2024, showed that TransCon PTH led to a mean increase in estimated glomerular filtration rate (eGFR) of 8.9 mL/min/1.73m2 after one year, maintained at 9.0 mL/min/1.73m2 at the two-year mark, with both results being statistically significant (p
The PaTHway Trial was a randomized, double-blind, placebo-controlled study involving 82 adults. Participants were initially co-administered with conventional therapy, which includes active vitamin D and oral calcium, and were later allowed to enter a 156-week open-label extension period. The analysis demonstrated that TransCon PTH treatment was generally well-tolerated with no new safety signals.
TransCon PTH is a prodrug of parathyroid hormone (PTH 1-34), administered daily and designed to maintain PTH levels within a normal range over a 24-hour period. The therapy has been granted marketing authorization in Europe and Great Britain under the name YORVIPATH® and is awaiting a decision by the Food & Drug Administration (FDA) in the United States, expected by May 14, 2024.
Dr. Aimee Shu, Senior Vice President of Clinical Development, Endocrine Medical Sciences at Ascendis Pharma, emphasized the potential of TransCon PTH to address issues like soft-tissue calcifications and decreased kidney function that are associated with standard treatments.
Hypoparathyroidism is an endocrine disorder characterized by insufficient levels of PTH, leading to complications such as renal issues, neuromuscular irritability, and cognitive impairment. The majority of cases are post-surgical, with autoimmune and idiopathic causes also recognized.
The findings from the PaTHway Trial suggest that TransCon PTH could offer a significant therapeutic benefit for patients with chronic hypoparathyroidism, potentially improving long-term kidney health. These results are based on a press release statement from Ascendis Pharma.
InvestingPro Insights
Ascendis Pharma A/S (NASDAQ:ASND) has recently made headlines with promising clinical trial results for TransCon PTH, which may revolutionize the treatment of chronic hypoparathyroidism. As investors digest the news, it's essential to consider the company's financial health and market performance to understand its potential fully.
According to real-time data from InvestingPro, Ascendis Pharma has a market capitalization of $7.62 billion, reflecting the market's valuation of the company in light of its recent developments and future prospects. Moreover, the company's revenue has experienced a staggering growth of 421.2% over the last twelve months as of Q4 2023, indicating a robust expansion in its financial performance.
InvestingPro Tips for Ascendis Pharma point to several critical insights. Notably, two analysts have revised their earnings upwards for the upcoming period, signaling confidence in the company's future financial results. Additionally, Ascendis Pharma's liquid assets exceed its short-term obligations, suggesting a strong liquidity position that could support ongoing research and development activities, including those related to TransCon PTH.
While analysts do not anticipate the company will be profitable this year, the InvestingPro platform offers additional insights into Ascendis Pharma's financials and market performance. With over eight additional InvestingPro Tips available, investors can gain a deeper understanding of the company's position. For those interested in exploring these tips and more, a special offer is available: use the coupon code PRONEWS24 to receive an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
Ascendis Pharma's journey in bringing TransCon PTH to market is not just a scientific endeavor but also a financial one. The InvestingPro Insights provide a glimpse into the company's economic landscape, complementing the clinical picture for a holistic view of its potential impact on patient care and investor returns.
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