COPENHAGEN - Ascendis Pharma A/S (NASDAQ:ASND) announced today that the UK's Medicines & Healthcare Products Regulatory Agency (MHRA) has authorized YORVIPATH (palopegteriparatide) for adult chronic hypoparathyroidism treatment in Great Britain and granted it orphan drug status.
The MHRA approval of YORVIPATH, a daily-administered prodrug of parathyroid hormone (PTH 1-34), is based on the same dossier that led to the European Commission's authorization in the European Union in November 2023. This orphan drug status ensures ten years of market exclusivity in Great Britain for the treatment of this condition.
Chronic hypoparathyroidism is characterized by insufficient levels of PTH, which regulates calcium and phosphate balance in the body. This endocrine disease can lead to serious complications such as neuromuscular irritability, renal issues, and cognitive impairment. The majority of cases are post-surgical, with other causes including autoimmune, genetic, and idiopathic factors.
Ascendis Pharma, with headquarters in Copenhagen, Denmark, is focused on applying its TransCon technology to develop new therapies. The company aims to meet the needs of adults with chronic hypoparathyroidism not just in Great Britain but also in the United States, Japan, and other countries where TransCon PTH is in development.
This announcement is based on a press release statement.
InvestingPro Insights
As Ascendis Pharma A/S (NASDAQ:ASND) secures another regulatory win with the MHRA approval of YORVIPATH, the company's financial metrics and market performance provide a broader context for investors. With a market capitalization of $8.27 billion and a notable revenue growth of 421.2% in the last twelve months as of Q1 2023, Ascendis is demonstrating significant progress. The company's gross profit margin stands impressively at 83.36%, highlighting its ability to manage production costs effectively despite not being profitable over the past year.
InvestingPro Tips for Ascendis Pharma indicate that while analysts have revised their earnings upwards for the upcoming period, they do not anticipate the company will be profitable this year. Nonetheless, Ascendis Pharma has experienced a large price uptick over the last six months with a 64.49% return, suggesting investor optimism following its recent developments.
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With a strong pipeline and expansion into new markets, Ascendis Pharma's strategic moves appear to align with their growth trajectory, as reflected in their recent revenue surge and market capitalization. Although the path to profitability remains a challenge, the company's liquid assets exceed short-term obligations, suggesting financial resilience in the near term. These financial insights, coupled with the company's latest regulatory success, paint a comprehensive picture for current and potential investors.
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