regulatory
confidence high
sentiment neutral
materiality 0.75
PTC Therapeutics provides regulatory timeline updates for sepiapterin, Upstaza, Translarna
PTC THERAPEUTICS, INC.
- Expects to submit NDA to FDA for sepiapterin (PKU) in Q4 2023.
- Expects to submit BLA to FDA for Upstaza (AADC deficiency) in Q3 2023.
- Expects CHMP opinion in Q3 2023 for Translarna (nmDMD) conversion to standard EU authorization.
- Preparing Type C FDA meetings for Translarna NDA resubmission and vatiquinone NDA for Friedreich ataxia.