Australia's Neuren Pharma soars as FDA accepts new drug application for review

Hanall Biopharma

13/09/2022 02:35

** Shares of biopharma co Neuren Pharmaceuticals  NEU.AX 
rise as much as 11.6% to A$6.950, their highest since June 22,
2007
    ** Co says U.S. Food and Drug Administration (FDA) has
granted a priority review to the New Drug Application (NDA) of
trofinetide for the treatment of Rett syndrome  urn:newsml:reuters.com:*:nASX6wXBQG
    ** Says the NDA was submitted by co's U.S. partner Acadia
Pharmaceuticals  ACAD.O  
    ** Says if the NDA is approved, co expects to earn revenue
over 2022 and 2023 for Rett syndrome in U.S. alone of A$118 mln
($81.30 mln) plus double-digit percentage royalties on net sales
    ** Adds the expected revenue includes a milestone payment
$10 mln in 2022 following acceptance of NDA for review by FDA
    ** Shares mark their biggest intraday pct gain since July 25
    ** As of last close, stock up 65.3% this year


($1 = 1.4514 Australian dollars)

 (Reporting by Himanshi Akhand in Bengaluru)
 ((Himanshi.Akhand@thomsonreuters.com;))