Ascendis submits NDA for TransCon CNP for achondroplasia

Seeking Alpha News (Mon, 31-Mar 5:51 PM)

  • Ascendis (ASND) has submitted a New Drug Application to the U.S. FDA seeking approval of TransCon CNP (navepegritide) for achondroplasia in children. 
  • The application is supported by data from three randomized, double-blind, placebo-controlled trials and up to three years of open-label extension data.
  • The company is slated to submit a Marketing Authorisation Application to the European Medicines Agency in Q3.
  • TransCon CNP is a prodrug of C-type natriuretic peptide given weekly. 
  • If approved, TransCon CNP would compete against BioMarin Pharmaceutical's (NASDAQ:BMRN) Voxzogo (vosoritide).