Brief: Pharnext Says EMA Agrees With Its Pediatric Investigation Plan For PXT3003
10/07/2018 06:34
July 10 (Reuters) - PHARNEXT SA PHARN.PA :
* EUROPEAN MEDICINES AGENCY AGREES WITH PHARNEXT’S PEDIATRIC
INVESTIGATION PLAN FOR PXT3003
* THIS AGREEMENT PAVES WAY FOR SUBMISSION OF A MARKETING
AUTHORIZATION APPLICATION IN EUROPE
* PXT3003 IS BEING EVALUATED IN AN INTERNATIONAL PIVOTAL
PHASE 3
CLINICAL TRIAL IN ADULTS WITH CMT1A, WITH TOP-LINE RESULTS
EXPECTED BY OCTOBER 2018
* CLINICAL STUDY INVESTIGATING SAFETY AND EFFICACY OF
PXT3003 FOR
CMT1A IN CHILDREN WILL BE CONDUCTED IN EUROPE, CANADA AND UNITED
STATES
Source text for Eikon: ID:nBw7zvVyba
Further company coverage: PHARN.PA
(Gdynia Newsroom)
((gdynia.newsroom@thomsonreuters.com; +48 58 772 09 20;))
Recent news on Pharnext SCA
See all newsBrief: Pharnext Progresses On Charcot-Marie-Tooth Disease Study
Brief: Pharnext Reports Topline Results From Pivotal Phase III Clinical Trial Of PXT3003 In Charcot-Marie-Tooth Disease Type 1A
Brief: Pharnext Receives Offer Valuing Its Drug Candidate For Charcotmarie-Tooth Disease At Over Eur 500 Mln
Brief: Pharnext Appoints Dr Gilbert Wagener As Chief Medical Officer
Brief: Pharnext Reports Significant Progress In Search For Pharmaceutical Partners To Finance Its Development