secwatch.observer — SEC 8-K summary
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Issuer:     PTC THERAPEUTICS, INC. (PTCT)
CIK:        0001070081
Form:       8-K
Filed at:   2023-07-19T23:59:59+00:00
Accession:  0001070081-23-000043
Event type: regulatory
Sentiment:  neutral
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

PTC Therapeutics provides regulatory timeline updates for sepiapterin, Upstaza, Translarna
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1070081/000107008123000043/0001070081-23-000043-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1070081/000107008123000043/tmb-20230719x8k.htm
  HTML page:      https://secwatch.observer/filing/0001070081-23-000043

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer