PTC Therapeutics Says CHMP Has Issued Negative Opinion On Renewal Of Conditional Marketing Authorization Of Translarna (Ataluren) For The Treatment Of nmDMD; Opinion Follows Return Of Previously Issued Negative Opinion By European Commission For Re-review
Portfolio Pulse from Benzinga Newsdesk
PTC Therapeutics announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion on the renewal of the conditional marketing authorization for Translarna (Ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). This follows a previous negative opinion by the European Commission, which was returned for re-review.
June 28, 2024 | 10:06 am
News sentiment analysis
Sort by:
Descending
NEGATIVE IMPACT
PTC Therapeutics received a negative opinion from CHMP on the renewal of the conditional marketing authorization for Translarna, a treatment for nmDMD. This follows a previous negative opinion by the European Commission.
The negative opinion from CHMP on the renewal of Translarna's conditional marketing authorization is a significant regulatory setback for PTC Therapeutics. This could negatively impact the company's stock price in the short term due to potential delays or inability to market the drug in Europe.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100