Submit global regulatory filings for vanzacaftor triple, including an NDA to the FDA and MAAs to EMA and Health Canada
Delivered by the deadline
AI-confirmed · human review in progress Independent AI checks agreed on primary SEC or regulator evidence. Records are now being reviewed by hand, starting with those our customers order.
- Announced
- 5 Feb 2024
- Due
- 30 Jun 2024
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Vertex intends to submit global regulatory filings by mid-2024 for the vanza triple, including a New Drug Application (NDA) to the U.S. FDA using a priority review voucher and MAAs to the EMA and Health”
What we found
Evidence strength A What the grades mean
The FDA accepted the vanzacaftor triple NDA and EMA/MHRA validated the MAAs by August 2024; acceptance within the standard 60-day filing review implies submission by about early June 2024.
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A Vertex Pharmaceuticals 8-K filed 2024-08-01
“Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for the once-daily vanzacaftor triple in people with CF 6 years and older and assigned Priority Review” ✓ confirmed on the page
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A Vertex Pharmaceuticals 8-K filed 2024-08-01
“Vertex also received validation of its vanzacaftor triple Marketing Authorization Application (MAA) submissions from the European Medicines Agency (EMA)” ✓ confirmed on the page
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A Vertex Pharmaceuticals 10-Q filed 2024-08-02
“We received validation of our vanzacaftor triple marketing authorization application (“MAA”) submissions from the EMA in the E.U. and the Medicines and Healthcare products Regulatory Agency (“MHRA”) in the U.K.” ✓ confirmed on the page
Market reaction: the shares moved +2.3% against the S&P 500 over the three sessions around the disclosure (31 Jul 2024 to 5 Aug 2024). What this measures
Checked 10 Oct 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Regulatory other
- Indicative materiality
- Medium rules
- Action
- Submit
- Deliverable
- Global regulatory filings for vanzacaftor triple in CF
- Where
- United States, European Union, Canada
- Language
- Aspirational (“aims”, “intends”)
- In the company’s control
- High
- Specificity
- Medium
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- First checkAn AI model, Claude (Anthropic), read the company's later filings and recorded the outcome with a quoted passage.
- Second check: agreesA different AI model, Gemini (Google), re-read the evidence without being told the outcome and reached the same answer.
Confirmed. This outcome counts towards the company's Kept Score. How verification works
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Report an error in this entry Reference: KI-C-2024-VRTX-006533 · Corrections policy