FDA Pushes Review Date For Ascendis Pharma's Hormone Disorder Candidate By Three Months
Portfolio Pulse from Vandana Singh
The FDA has extended the review date for Ascendis Pharma's (NASDAQ: ASND) TransCon PTH for hypoparathyroidism by three months to August 14, 2024. This extension is due to a major amendment in the New Drug Application. Despite the delay, patients in clinical trials and the Expanded Access Program will continue to receive the medication.
May 15, 2024 | 3:57 pm
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The FDA has extended the review date for Ascendis Pharma's TransCon PTH by three months due to a major amendment in the NDA. This delay may cause short-term uncertainty but ongoing patient access in clinical trials and EAP is maintained.
The extension of the review date introduces short-term uncertainty regarding the approval timeline, which could affect investor sentiment. However, the continued access for patients in clinical trials and the EAP mitigates some of the potential negative impact.
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