Submit investigational new drug application for Fabry disease

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: 27 Feb 2023
Due: 31 Dec 2023
Delivered: 29 Nov 2023

Deadline
Met
Late
Not met
Today

What the company said

“readying for the submission of an investigational new drug application in Fabry disease in 2023”

SourceuniQure N.V. Form 8-K press release, 2023-02-27
FilingSEC filing index
Deadline as statedin 2023
Deadline used31 Dec 2023, the last day of the stated period
TypeRegulatory
Permanent referenceKI-C-2023-QURE-001822
Cite as https://keptindex.org/c/KI-C-2023-QURE-001822/ — this address never changes.

What we found

Evidence strength A What the grades mean

The company announced in November 2023 that the FDA had cleared its investigational new drug application for AMT-191, which is its gene therapy candidate for Fabry disease.

A
uniQure N.V. 10-K filed 2024-02-28 Regulatory filing · published 28 Feb 2024 · retrieved 1 Oct 2026 · kept permanently by the SEC
“On November 29, 2023 we announced that the FDA had cleared the IND application for AMT-191” ✓ confirmed on the page

Market reaction: the shares moved -18.4% against the S&P 500 over the three sessions around the disclosure (27 Feb 2024 to 1 Mar 2024). 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.

2 versions

Version 1 · original · stated 27 Feb 2023

Deadline 31 Dec 2023 (“in 2023”)
Version 2 · stated 9 May 2023

Deadline 31 Dec 2023 (“second half of 2023”) · wording expected

“The Company expects to submit an investigational new drug (IND) application and initiate a Phase I/II clinical study of AMT-260 in the second half of 2023.”
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: Fabry disease IND application
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, Gemini (Google), read the company's later filings and recorded the outcome with a quoted passage.
Second check: agreesA different AI model, Claude (Anthropic), 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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