Ascendis Announces Extension of FDA Review Period for TransCon CNP (navepegritide) for Children with Achondroplasia

Core Viewpoint - Ascendis Pharma A/S announced that the FDA has extended the PDUFA target action date for TransCon CNP by three months to February 28, 2026, due to a major amendment related to post-marketing requirements [1]. Group 1: FDA Interaction - The company has responded to all outstanding FDA requests, including a revised protocol for the post-marketing study, and is committed to working diligently with the FDA to finalize these elements [2]. - The extension of the PDUFA date indicates ongoing regulatory review and the need for additional information from the company [1]. Group 2: Company Overview - Ascendis Pharma is a global biopharmaceutical company focused on innovative therapies using its TransCon technology platform to address unmet medical needs [3]. - The company is headquartered in Copenhagen, Denmark, with additional facilities in Europe and the United States [3].