Ascendis Pharma submits TransCon CNP for achondroplasia to EMA and FDA under review
Reuters
Oct 09, 2025
Ascendis Pharma submits TransCon CNP for achondroplasia to EMA and FDA under review
Ascendis Pharma A/S has submitted a Marketing Authorisation Application $(MAA)$ to the European Medicines Agency $(EMA)$ for TransCon CNP (navepegritide) as a treatment for children with achondroplasia. The application is supported by data from three randomized, double-blind, placebo-controlled clinical trials, as well as up to three years of open-label extension data, demonstrating that TransCon CNP was generally well tolerated. In the United States, TransCon CNP is also under priority review by the FDA, with a decision expected by November 30, 2025. No grant or funding from multiple organizations was mentioned.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Ascendis Pharma A/S published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9542451-en) on October 08, 2025, and is solely responsible for the information contained therein.
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