PTCT - European Authority Gives Thumbs Down To PTC Therapeutics' Duchenne Therapy; Analyst Says It Can Overturn The Challenge | Benzinga
Friday morning, the Committee for Medicinal Products for Human Use of the European Medicines Agency gave a negative opinion on the conversion of the conditional marketing authorization to full marketing authorization of PTC Therapeutics Inc's (NASDAQ: PTCT) Translarna (ataluren) for nonsense mutation Duchenne muscular dystrophy.
The negative opinion also applies to the renewal of the existing conditional authorization.
PTC plans to submit a request for re-examination. Translarna will remain on the market and available until the re-examination process is completed.
Following the re-examination process, the opinion would be expected to occur in January 2024, with the European Commission ratifying the opinion within the following 67 days.
Translarna received conditional marketing authorization ...