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Ascendis Q3 product revenue rises 89% to €366M as CHMP backs TransCon CNP

Ascendis Pharma A/S (ASND) · Thu 12 Nov 2026

Ascendis Pharma reported strong third-quarter growth led by YORVIPATH and said the CHMP and COMP have issued positive opinions for TransCon CNP in paediatric achondroplasia.

Ascendis Pharma reported third-quarter 2026 product revenue of €366 million on 12 November, an increase of 89%. YORVIPATH was the main driver, contributing €291 million. SKYTROFA and the newly launched YUVIWEL also contributed to the total.

The company posted an operating profit of €125 million for the quarter.

On the regulatory side, the CHMP adopted a positive opinion for TransCon CNP in paediatric achondroplasia. The COMP also issued a positive opinion supporting retention of the product's orphan designation. Ascendis expects a final European Commission decision in the fourth quarter of 2026, with a launch in Germany planned for the first quarter of 2027.

Ascendis also pointed to infant Week 52 data for the programme. It expects pivotal topline data in the third quarter of 2027.

In the EU, a positive CHMP opinion is a recommendation that the Commission usually follows when it issues the legally binding marketing authorisation decision. The COMP's opinion on orphan status is assessed separately from the CHMP's benefit-risk review.

What it means for your team

  • Regulatory teams should track the expected Q4 2026 European Commission decision on TransCon CNP, which would turn the CHMP opinion into an authorisation.
  • Retention of orphan designation, backed by the COMP, is relevant to the product's positioning in paediatric achondroplasia.
  • Market-access teams should note the planned German launch in Q1 2027, which sets the timing for national pricing and reimbursement work.
  • Further pivotal topline data are expected in Q3 2027, which may inform later evidence discussions.

Company's press release (SEC filing): Ascendis Pharma A/S ↗

Article written by VigiEye from the official source (Ascendis Pharma A/S). Claims are the company's own. AI-assisted; check the source before acting.

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