The U.S. Food and Drug Administration extended the review clock for Ascendis Pharma’s once‑weekly therapy for achondroplasia, citing questions around the design of the treatment’s post‑marketing study. Ascendis disclosed the three‑month delay in company filings and said it is working with the agency to address requirements tied to long‑term safety monitoring. The postponement affects commercial timelines and highlights regulators’ increasing scrutiny of post‑approval evidence commitments for pediatric and rare‑disease therapies. Ascendis will need to finalize the post‑marketing study protocol to secure a new target action date and to clarify obligations tied to any potential approval.