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
News sentiment analysis
Sort by:
Descending
NEUTRAL IMPACT
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.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100