---
schema_version: "secwatch.filing_event.v1"
accession: "0001070081-23-000043"
form_type: "8-K"
ticker: "PTCT"
cik: "0001070081"
company_name: "PTC THERAPEUTICS, INC."
filed_at: "2023-07-19T23:59:59+00:00"
generated_at: "2026-06-13T06:13:09.618762+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# PTC Therapeutics provides regulatory timeline updates for sepiapterin, Upstaza, Translarna

## Summary
- 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.

## SEC filing metadata
- accession: 0001070081-23-000043
- form_type: 8-K
- ticker: PTCT
- cik: 0001070081
- company_name: PTC THERAPEUTICS, INC.
- filed_at: 2023-07-19T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1070081/000107008123000043/0001070081-23-000043-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1070081/000107008123000043/tmb-20230719x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001070081-23-000043
- JSON: https://secwatch.observer/filing/0001070081-23-000043.json
- Plain text: https://secwatch.observer/filing/0001070081-23-000043.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.