The FDA extended its review of Ascendis Pharma’s TransCon CNP (a once‑weekly treatment for achondroplasia) by three months to allow additional evaluation of the company’s post‑marketing study protocol and other submitted information. Ascendis said the delay centers on clarifying the post‑approval requirements for the therapy. Regulatory extensions of PDUFA dates are common when agencies request supplementary information or additional safety data. For Ascendis, the extension postpones potential market entry timing and influences commercial planning, particularly given the small‑patient‑population dynamics and potential for priority review vouchers. Investors and prescribers will monitor the FDA’s questions and the company’s responses; the final decision and any labeling commitments will affect uptake and further regulatory negotiations globally.