FDA Approves Ascendis Pharma A/S Resubmission of TransCon PTH Market Application

☀️Trending News

Ascendis ($NASDAQ:ASND) Pharma A/S is a global biopharmaceutical company developing innovative and transformative therapies to improve the lives of patients. Recently, the U.S. Food and Drug Administration (FDA) accepted their resubmitted application for the TransCon PTH product to enter the market. The TransCon PTH product is a long-acting, once-weekly injection that provides sustained levels of human parathyroid hormone (hPTH) and is designed to reduce the dose frequency compared to existing daily injections. It is the first and only weekly long-acting treatment for hypoparathyroidism and has the potential to improve patient convenience and compliance. The FDA had previously declined to approve Ascendis’ application, citing concerns about product chemistry, manufacturing, and controls (CMC).

Ascendis addressed the FDA’s concerns with additional data, including preclinical studies and data from human clinical trials. The FDA accepted the company’s resubmission, giving them the go-ahead to market the product. The approval of this drug could have a significant impact on the lives of those living with hypoparathyroidism, providing them with a much more manageable treatment option.

Market Price

Monday marked a significant day for Ascendis Pharma A/S, following the US Food and Drug Administration’s (FDA) approval of the company’s resubmission of the TransCon PTH Market Application. This approval has been highly anticipated by the market, resulting in the stock opening at $107.8 on Monday and closing at $108.6, representing a 0.8% increase from its last closing price of $107.7. This approval represents an important milestone for Ascendis Pharma A/S as TransCon PTH is its first-in-class therapy and could potentially revolutionize how hypoparathyroidism is treated. The drug’s approval in the US is a major step towards the commercialization of the therapy and will open up new opportunities for the company, both domestically and internationally. Live Quote…

About the Company

Income Snapshot

Below shows the total revenue, net income and net margin for ASND. More…

Cash Flow Snapshot

Below shows the cash from operations, investing and financing for ASND. More…

Balance Sheet Snapshot

Below shows the total assets, liabilities and book value per share for ASND. More…

Key Ratios Snapshot

Some of the financial key ratios for ASND are shown below. More…

Analysis

At GoodWhale, our analysis of ASCENDIS PHARMA A/S’s fundamentals shows that it is classified as a ‘cheetah’ company. This type of company is said to have achieved high revenue or earnings growth, but is considered less stable due to lower profitability. We believe this type of company may be attractive to value and growth investors since they are able to capitalize on the growth opportunities while minimizing risk. When looking at the Star Chart, we found that ASCENDIS PHARMA A/S is strong in growth, medium in asset and weak in dividend, profitability. Furthermore, the company has a low health score of 2/10 with regard to its cashflows and debt, which suggests that it is less likely to pay off debt and fund future operations. As such, investors should be aware of the risks associated with investing in this company. More…

Peers

Ascendis Pharma A/S, Hard to Treat Diseases Inc, Shanghai Bio-heart Biological Technology Co Ltd, and China Regenerative Medicine International Ltd are all companies that focus on developing treatments for hard-to-treat diseases. While each company has its own unique approach, they all share the common goal of helping patients with difficult-to-treat conditions.

– Hard to Treat Diseases Inc ($OTCPK:HTDS)

Shanghai Bio-heart Biological Technology Co Ltd is a Chinese company that focuses on the research and development of cardiovascular therapeutics. The company’s market cap as of 2022 is 11.97 billion, and its ROE is -18.92%. Shanghai Bio-heart Biological Technology Co Ltd’s products include treatments for heart failure, myocardial infarction, and arrhythmia.

– Shanghai Bio-heart Biological Technology Co Ltd ($SEHK:02185)

China Regenerative Medicine International Ltd. is a Hong Kong-based investment holding company principally engaged in the provision of medical services. The Company operates its business through three segments. The In-patient Services segment is engaged in the provision of medical services to in-patients. The Out-patient Services segment is engaged in the provision of medical services to out-patients. The Others segment is engaged in the provision of other services. The Company operates a hospital, which is located in Shenzhen, the People’s Republic of China (PRC).

Summary

Ascendis Pharma A/S is a biopharmaceutical company focused on the development of hormone therapies and prodrugs. Recently, the U.S. Food and Drug Administration (FDA) accepted the company’s resubmission of its New Drug Application (NDA) for TransCon PTH, an injectable long-acting prodrug of parathyroid hormone. This is a major milestone for the company, as the drug could be a potential treatment for adults with hypoparathyroidism. Investors should take note of the potential for Ascendis on the market, as TransCon PTH could offer a more convenient form of delivery and improved efficacy compared to existing treatments.

Additionally, the company has several pipeline products in development, with the potential to expand its portfolio of hormone therapies. With its recent NDA acceptance, Ascendis is well-positioned to unlock new growth opportunities, making it an attractive investment opportunity.