Initiate Process Performance Qualification run
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
- 2 Jun 2025
- Due
- 30 Sep 2025
- Delivered
- July 2025
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“initiate PPQ run”
What we found
Evidence strength B What the grades mean
uniQure initiated PPQ campaign in July 2025, within the Q3 2025 deadline, and planned completion for Q4 2025.
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B uniQure Announces Second Quarter 2025 Financial Results and Highlights of Recent Company Progress
“Additionally, the Company initiated its PPQ campaign to support the planned BLA submission.”
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B uniQure Provides Regulatory Update on AMT-130 for Huntington's Disease
“- Q2 2025: submit updated SAP to the FDA - Q3 2025: initiate PPQ run and present topline Phase I/II data per the SAP - Q4 2025: hold pre-BLA meeting with the FDA”
Checked 8 Oct 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Product other
- Indicative materiality
- Low rules
- Action
- Initiate
- Deliverable
- Process Performance Qualification run
- In the company’s control
- High
- Specificity
- High
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-2025-QURE-001912 · Corrections policy