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Ascendis' New Drug Application for Investigational Drug to Treat Genetic Disorder Accepted by FDA for Priority Review
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Ascendis' New Drug Application for Investigational Drug to Treat Genetic Disorder Accepted by FDA for Priority Review
Jun 2, 2025 7:58 AM

10:34 AM EDT, 06/02/2025 (MT Newswires) -- Ascendis Pharma ( ASND ) said Monday its new drug application for the TransCon CNP candidate to treat children with achondroplasia, a genetic condition, was accepted by the US Food and Drug Administration for priority review.

The FDA set a prescription drug user fee act date of November 30 to close the review process, according to a statement.

The US regulator is not currently planning to conduct an advisory committee meeting to discuss the application, the company said.

Shares were up 5.4% in recent trading.

Price: 171.52, Change: +8.68, Percent Change: +5.33

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