Ascendis Pharma A/S Resubmits NDA for TransCon™ PTH to the U.S. FDA

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Ascendis ($NASDAQ:ASND) Pharma A/S is a late-stage biopharmaceutical company committed to developing a robust pipeline of long-acting therapies to help patients lead healthier lives. The company recently announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product TransCon™ PTH, a once-weekly, long-acting prodrug of parathyroid hormone (PTH), for the treatment of children with hypoparathyroidism. Ascendis Pharma has addressed all questions raised by the FDA and is now seeking approval for TransCon™ PTH as a once-weekly, long-acting subcutaneous therapy for adults and pediatric patients with primary hypoparathyroidism. If approved, TransCon™ PTH will be the first and only once-weekly, long-acting prodrug of PTH in the U.S. This will provide hypoparathyroidism patients with an important new option to manage their condition more effectively while reducing the burden of frequent injections. Ascendis Pharma is also pursuing regulatory approvals for TransCon™ PTH in Europe and other international markets.

Price History

On Thursday, shares of Ascendis Pharma A/S opened at $93.3 and closed at $93.5, up by 0.6% from the prior closing price of 93.0. The company had announced the same day that it had resubmitted its New Drug Application (NDA) for TransCon™ PTH to the U.S. Food and Drug Administration (FDA). TransCon™ PTH is Ascendis Pharma A/S’ innovative new therapy designed to reduce the need for multiple daily injections of PTH in adult patients with hypoparathyroidism. With the resubmission of the NDA, the company is hoping for FDA approval of the therapy, which could revolutionize treatment for this disorder.

In its resubmission, Ascendis provides additional data from its ongoing Phase 3 clinical study, as well as data from a long-term extension study and additional nonclinical studies. If approved, TransCon™ PTH would provide a much needed therapeutic option for patients with hypoparathyroidism, offering a safe and effective way to manage this disorder. Live Quote…

About the Company

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Analysis

GoodWhale has conducted an analysis of ASCENDIS PHARMA A/S’s wellbeing. According to the Star Chart, ASCENDIS PHARMA A/S is classified as a ‘cheetah’, a type of company that has achieved high revenue or earnings growth but is considered less stable due to lower profitability. This type of company would be of interest to investors who are looking for a higher-risk but potentially higher-reward investment opportunity. However, ASCENDIS PHARMA A/S scored poorly on our health metric, receiving 2 out of 10. This suggests that, due to low cashflow and debt management, it may not be able to sustain operations in times of crisis. Additionally, while it is strong in growth, it has only an average score in asset and a weak score in dividend and profitability. Overall, ASCENDIS PHARMA A/S is an attractive opportunity for investors looking for a high-growth and high-risk investment but requires careful consideration due to its low health score. 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 based in Denmark focused on developing innovative treatments for rare and endocrine diseases. The company recently resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its TransCon™ PTH drug, designed to treat hypoparathyroidism. Recent investment analysis of Ascendis Pharma A/S suggests that the company has significant potential for growth, thanks to its strong pipeline of drugs and promising clinical trials. The stock price has shown an upward trend since the announcement of the NDA resubmission.

Analysts are optimistic that the TransCon™ PTH drug will receive approval from the FDA, and that Ascendis Pharma will continue to make progress in its other development programs. It is recommended that investors do their own research and assess their own risk appetite before investing in the company.