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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