Newron stock jumps on hopes for Xadago drug

Newron Pharmaceuticals SpA

26/07/2016 09:05

ZURICH, July 26 (Reuters) -    * Shares in Newron 
Pharmaceuticals  NWRN.S  rose around 15 percent on Tuesday on 
hopes for its Parkinson's disease treatment Xadago  
    * The Swiss-listed Italian group and partners Zambon and US 
WorldMeds announced the U.S. Food and Drug Administration (FDA) 
and its Controlled Substance Staff (CSS) no longer require 
Newron to perform any studies to clinically evaluate the 
potential abuse liability or dependence/withdrawal effects of 
Xadago.  
    * A complete response letter from the FDA in March did not 
require submission of any additional new data/studies/analyses 
for efficacy or safety in patients with Parkinson's disease, 
thus Newron will now expedite re-submission of the New Drug 
Application (NDA) to the FDA. 
    * CMO Ravi Anand said in a statement: "Newron and the FDA 
agreed on the contents of the NDA re-submission which Newron 
expects to complete by November of this year." 
 
 (Reporting by Zurich newsroom) 
 ((zurich.newsroom@thomsonreuters.com; +41 58 306 7336;)) 
 
Keywords: NEWRON DRUG/