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PTC Therapeutics (PTCT) pipeline and stated timing

Pipeline at a glance

ProgramEventStageStated timingFiling
vatiquinone submission—in December 202410-Q ·
ST-920NDA/BLA submission—in 20268-K ·

Source: ORION, orionbiotechai.com/company/PTCT, data as of Oct 18, 2026
https://www.orionbiotechai.com/company/PTCT

Nearest upcoming stated timing: ST-920 · NDA/BLA submission · in Q4 2026

SEC sources last checked .

Programs and stated timing

○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.

vatiquinone

Friedreich ataxia

Matched

NDA/BLA submissionin December 2024

Stage: —

Public float: $3,350,589,128 · as of · SEC filing

The Company plans to submit an NDA for vatiquinone for the treatment of FA in the United States in December 2024.

10-Q · Filed · Last checked

Source details

Accession 0001070081-24-000023

Resolution filing: · SEC filing

How this date was described over time

Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of .

Program / eventStated period and SEC wordingDisclosure in stated period
ST-920Submissionin Q4 2026
“A rolling BLA submission to FDA for accelerated approval of ST-920 is expected to be completed in Q4 2026.”

Filed · EX-99.1

Still within period

As of Oct 19, 2026

ST-920Submissionin the fourth quarter of 2026
“a rolling biologics license application (“BLA”) submission to the U.S. Food and Drug Administration for accelerated approval of ST-920 is expected to be completed in the fourth quarter of 2026.”

Filed · 8-K

Not compared

ORION has no confirmed start and end dates for this wording, so it is not compared with filings.

ST-920Submissionin Q4 2026
“A rolling BLA submission to FDA for accelerated approval of ST-920 is expected to be completed in Q4 2026.”

Filed · EX-99.1

Still within period

As of Oct 19, 2026

ST-920Submissionin the fourth quarter of 2026
“A rolling biologics license application (“BLA”) submission to FDA for accelerated approval of ST-920 is expected to be completed in the fourth quarter of 2026.”

Filed · 8-K

Not compared

ORION has no confirmed start and end dates for this wording, so it is not compared with filings.

vatiquinoneSubmissionin December 2024
“The Company plans to submit an NDA for vatiquinone for the treatment of FA in the United States in December 2024.”

Filed · 10-Q

Not compared

The stated period has ended. ORION has no record of a complete search of SEC filings from that period.

vatiquinoneSubmissionin December 2024
“We plan to submit an NDA for vatiquinone for the treatment of FA in the United States in December 2024.”

Filed · 10-Q

Not compared

The stated period has ended. ORION has no record of a complete search of SEC filings from that period.

vatiquinoneSubmissionin December 2024
“PTC plans to submit an NDA for vatiquinone for the treatment of Friedreich ataxia in December 2024.”

Filed · EX-99.1

Not compared

The stated period has ended. ORION has no record of a complete search of SEC filings from that period.

“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.

Retained company announcements

Historical summaries and source dates are retained separately from the SEC timing quotes above. Earlier publications were collected retrospectively.

Historical catalog checked .

No historical announcement trail is retained for this company in this catalog.

Selected registry record

Sepiapterin · NCT06302348

Condition in the selected registry record
Phenylketonuria
Phase in the selected registry record
Phase 3
Identity checked

Original ClinicalTrials.gov record · Open the selected study

Retained company–study identity sources

Scope of retained company and registry evidence

These are selected linked records and dated source metadata, not a live registry recheck or the company’s full pipeline. Company announcements and the selected registry study are separate evidence sets. No stage or event timing is borrowed between them.

Coverage and identity checks

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Reading these records

First stated window
The timing wording in the earliest company statement located within the sources checked, quoted as written (for example “2H 2026”). An earlier statement may exist outside those sources.
Disclosure date
The date of the filing or company release that disclosed the readout. “None found” means no such disclosure was located in the sources checked. SEC filings were searched through the “SEC filings searched through” date shown.
1H, 2H, 1Q–4Q
First or second half, or first to fourth quarter, of the year named, as the company wrote it. Equivalent notations are compared together; the original wording stays visible.
SEC original
The filing as published on the SEC EDGAR system. “Company original” is the release on the company's own investor site.
Status
One of seven labels set by founder review of the original filings. Definitions: Methodology.

See PTCT in the calendar · Review labels and methodology

A New Drug Application (NDA) or Biologics License Application (BLA) asks the FDA to approve a drug or biologic for sale.Q1–Q4 (also written 1Q–4Q) are quarters of the year: Q1 is January–March, Q2 April–June, Q3 July–September and Q4 October–December, unless the company uses a different fiscal year.