BUZZ-PTC Therapeutics falls as muscular disorder drug fails to get EU regulator's backing

Reuters · 09/15/2023 13:13
BUZZ-PTC Therapeutics falls as muscular disorder drug fails to get EU regulator's backing

** Shares of drugmaker PTC Therapeutics Inc PTCT.O fall 29.13% to $26.50 premarket

** PTCT says the EU regulator's Committee for Medicinal Products for Human Use has given a opinion on conversion of Translarna drug authorization to full use from existing conditional authorization

** Drug ataluren, under the brand Translarna, is used the treatment of a rare muscle-wasting disease, duchenne muscular dystrophy, with a type of genetic mutation

** The committee also doesn't recommends renewal of the drug's conditional authorization, which was last renewed in 2017 in Europe

** Recommendation follows full re-evaluation of the benefits and risks of the medicine, including results of a study that failed to confirm its effectiveness - European Medicines Agency

** Co plans to submit a request for re-examination

** The U.S. FDA has earlier declined to approve the drug

** Up to last close, stock down 2% YTD



(Reporting by Sriparna Roy in Bengaluru)

((Sriparna.Roy@thomsonreuters.com;))