COPENHAGEN, Denmark — Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) notified the Company that information submitted on November 5, 2025, related to the post-marketing requirement, in response to the FDA’s ongoing review of the New Drug Application (NDA) for TransCon CNP (navepegritide) for children with achondroplasia, constituted a major amendment to the NDA. Accordingly, the FDA has extended the PDUFA target action date by three months to February 28, 2026.
“We have responded to all outstanding requests from the FDA, including the request for a revised protocol for the post-marketing study, which we received as the lone item for discussion at our late-cycle meeting,” said Jan Mikkelsen, President and Chief Executive Officer at Ascendis Pharma. “We are committed to working diligently with the FDA to finalize elements of the post-marketing requirement, with the goal of bringing this innovative therapy to patients in the U.S. as soon as possible.”
About Ascendis Pharma A/S
Ascendis Pharma is a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more.
Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, and TransCon are trademarks owned by the Ascendis Pharma group. © November 2025 Ascendis Pharma A/S.
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