COPENHAGEN - Ascendis Pharma A/S (NASDAQ:ASND), a biopharmaceutical company, has received notice from the U.S. Food and Drug Administration (FDA) that the review period for its New Drug Application (NDA) for TransCon PTH has been extended. The Prescription Drug User Fee Act (PDUFA) goal date is now set for August 14, 2024, a three-month extension to allow the FDA additional time to evaluate a major amendment to the NDA.
TransCon PTH (palopegteriparatide) is designed to treat adults with hypoparathyroidism, a condition where the parathyroid glands fail to produce sufficient amounts of the parathyroid hormone, leading to low calcium levels and muscle spasms. The extension follows the submission of additional information by Ascendis Pharma in response to the FDA's requests during its ongoing review process.
Jan Mikkelsen, President and CEO of Ascendis Pharma, stated that the company has addressed all the FDA's requests to date and will continue to collaborate with the agency as it completes its review of the NDA. Mikkelsen also emphasized the company's commitment to making TransCon PTH available to U.S. adults with hypoparathyroidism, who currently have limited treatment options.
Patients in the United States who are participating in Ascendis Pharma's clinical trials and Expanded Access Program (EAP) for TransCon PTH will continue to receive their medication, and the EAP remains open for enrollment to eligible patients.
Ascendis Pharma is headquartered in Copenhagen, Denmark, with additional facilities in Europe and the United States. The company is focused on applying its proprietary TransCon technology to develop new therapies with potential best-in-class efficacy.
InvestingPro Insights
As Ascendis Pharma A/S (NASDAQ:ASND) navigates the regulatory process with its New Drug Application for TransCon PTH, investors and stakeholders are closely monitoring the company's financial health and market performance. According to InvestingPro data, Ascendis boasts a substantial market capitalization of $7.54 billion, highlighting its significant presence in the biopharmaceutical industry. Despite analysts not expecting the company to be profitable this year, Ascendis has demonstrated impressive revenue growth, with a 421.2% increase in the last twelve months as of Q1 2023, and an even more striking quarterly revenue growth of 501.42% in Q1 2023. This robust growth is a testament to the company's potential and the market's anticipation of its future performance.
In terms of financial stability, an InvestingPro Tip reveals that Ascendis operates with a moderate level of debt and its liquid assets exceed short-term obligations, suggesting a strong position to manage its financial commitments. However, it's important to note that the company is trading at a high revenue valuation multiple, which could indicate that the market has already priced in some of its future growth prospects. Investors should also be aware that Ascendis does not pay a dividend, directing its focus instead on reinvestment and growth.
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Ascendis Pharma's journey towards making TransCon PTH available to patients in need is not only a matter of regulatory approval but also of maintaining a strong financial foundation to support its innovative treatments. With the InvestingPro platform, interested parties can stay informed on the latest financial data and expert analysis to better understand the investment landscape surrounding this dynamic biopharmaceutical company.
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