Ascendis Pharma and BioMarin Reach Global Settlement for Yuviwel

Shots: Ascendis Pharma has entered into a binding term sheet with BioMarin for a global settlement & license agreement covering Yuviwel (navepegritide) & related products, resolving ongoing litigation & disputes between the companies As per the deal, BioMarin will grant Ascendis a non-exclusive, worldwide, royalty-bearing license to research, develop, manufacture & commercialize navepegritide-related products without…

ByRidhi RastogiSeptember 1, 2026

Ascendis’ Yuviwel (Navepegritide) Receives the US FDA Accelerated Approval for Achondroplasia

Shots: FDA granted accelerated approval to Yuviwel (navepegritide, QW) to increase linear growth in children (≥2yrs.) with achondroplasia & open epiphyses; commercially available by Q2’26 Approval was based on extensive clinical data, incl. 3 PBO-controlled trials plus up to 3yrs. of OLE data, with the pivotal ApproaCH results published in JAMA Pediatrics Continued approval may…

ByRidhi RastogiMarch 2, 2026

Ascendis Pharma Reports the EMA’s MAA Submission for TransCon CNP to Treat Achondroplasia in Children

Shots: The EMA has received MAA for TransCon CNP (navepegritide) for the treatment of children with achondroplasia; NDA is under the US FDA’s priority review (PDUFA: Nov 30, 2025) MAA is supported by 3 trials assessing TransCon CNP vs PBO & up to 3yrs. of OLE data, incl. ApproaCH trial results in children with achondroplasia,…

ByRidhi RastogiOctober 9, 2025

Ascendis Pharma and BioMarin Reach Global Settlement for Yuviwel

Ascendis’ Yuviwel (Navepegritide) Receives the US FDA Accelerated Approval for Achondroplasia

Ascendis Pharma Reports the EMA’s MAA Submission for TransCon CNP to Treat Achondroplasia in Children

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