PTC Therapeutics Provides Key Regulatory Updates

March 19, 2024

https://www.prnewswire.com/news-releases/ptc-therapeutics-provides-key-regulatory-updates-302092241.html

– BLA submitted to FDA for Upstaza™ for the treatment of AADC deficiency –

– NDA to be submitted mid-year for Translarna™ based on FDA feedback –

SOUTH PLAINFIELD, N.J., March 19, 2024 /PRNewswire/ — PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced the submission of a BLA to the U.S. FDA for Upstaza™ (eladocagene exuparvovec), a gene therapy for the treatment of aromatic L-amino acid decarboxylase (AADC) deficiency. In addition, based on recent feedback from the FDA, PTC plans to re-submit an NDA for Translarna™ (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). PTC expects to make the NDA resubmission by mid-year.

Read more at prnewswire.com

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