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uniQure N.V.

Submit a BLA for AMT-130 to the FDA

Not 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
24 Sep 2025
Due
31 Mar 2026
Checked
1 Oct 2026
  • Deadline
  • Met
  • Late
  • Not met
  • Today

What the company said

“uniQure plans to submit a BLA in the first quarter of 2026”
  • SourceuniQure N.V. Form 8-K press release, 2025-09-24
  • FilingSEC filing index
  • Deadline as statedin the first quarter of 2026
  • Deadline used31 Mar 2026, the last day of the stated period
  • TypeRegulatory
  • Permanent referenceKI-C-2025-QURE-001923
    Cite as https://keptindex.org/c/KI-C-2025-QURE-001923/ — this address never changes.

What we found

Evidence strength A What the grades mean

The company did not submit the BLA in the first quarter of 2026 as planned; subsequent filings indicate the submission was delayed to the third quarter of 2026.

  • A
    uniQure N.V. 8-K filed 2026-06-17 Regulatory filing · published 17 Jun 2026 · retrieved 1 Oct 2026 · kept permanently by the SEC · fingerprint 6a84b4b72cb5
    “Company intends to submit the BLA in third quarter of 2026” ✓ confirmed on the page
  • A
    uniQure N.V. 10-Q filed 2026-07-29 Regulatory filing · published 29 Jul 2026 · retrieved 1 Oct 2026 · kept permanently by the SEC · fingerprint 130470672037
    “we expect to submit a BLA in the third quarter of 2026.” ✓ confirmed on the page

Market reaction: the shares moved +65.0% against the S&P 500 over the three sessions around the disclosure (16 Jun 2026 to 22 Jun 2026). What this measures

Checked 1 Oct 2026.

Commitment lineage

Every time the company restated this commitment. The original is never changed, and the outcome is always measured against version 1.

  • 1 versions
  1. Version 1 · original · stated 24 Sep 2025

    Deadline 31 Mar 2026 (“in the first quarter of 2026”) · wording expected

  2. Version 2 · stated 29 Jul 2026

    Deadline 30 Sep 2026 (“third quarter of 2026”) · wording expected

    “the Company expects to submit a BLA in the third quarter of 2026”

    Source for this version

Commitment DNA

The structured record of this commitment. Fields the company did not state are left blank rather than guessed.

Event type
Regulatory submission
Indicative materiality
High rules
Action
Submit
Deliverable
BLA for AMT-130
Where
U.S.
Language
Expected (“expects”, “plans”)
In the company’s control
High
Specificity
High
Conditional
Yes: pending approval
Depends on
Regulatory

How this entry was checked

  1. Commitment recordedThe company's words were matched word for word against the filing.
  2. First checkAn AI model, Gemini (Google), read the company's later filings and recorded the outcome with a quoted passage.
  3. Second check: agreesA different AI model, Claude (Anthropic), re-read the evidence without being told the outcome and reached the same answer.
  4. Third check on a negative finding: agreesBecause a negative finding could harm a company if wrong, a stronger model re-read the evidence fully blind 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-001923 · Corrections policy

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