The FDA extended its review of Ascendis Pharma’s TransCon CNP for achondroplasia by three months, citing the need to evaluate recently submitted information related to the treatment’s post‑marketing study protocol. The delay pushes the regulatory action date back while the agency examines assurances around long‑term safety monitoring and required confirmatory trials. TransCon CNP is Ascendis’ once‑weekly growth factor prodrug designed to treat children with achondroplasia. The extension signals additional regulatory scrutiny on pediatric surrogate endpoints and post‑approval commitments but does not constitute a rejection; Ascendis will have until the new deadline to address FDA queries.