Animedix

Yuviwel (navepegritide / TransCon CNP) PDUFA Date (Ascendis Pharma)

FDA PDUFA decision date for Yuviwel (navepegritide / TransCon CNP) is February 28, 2026. Developed by Ascendis Pharma. Indication: Achondroplasia (pediatric). Current status: Approved.

Indication

Achondroplasia (pediatric)

Regulatory details

  • Company: Ascendis Pharma
  • Therapeutic area: Rare Disease / Bone
  • Application type: NDA
  • Review type: Priority
  • PDUFA date: 2026-02-28
  • Outcome: Approved