Submit IND and initiate Phase I/II clinical study of AMT-260
Not delivered by the deadline
AI-assessed · human review in progress Found and assessed by AI from the cited sources. Shown with its evidence; it is not counted in any Kept Score until confirmed.
- Announced
- 27 Feb 2023
- Due
- 31 Dec 2023
- Checked
- 1 Oct 2026
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“The Company expects to submit an investigational new drug application and initiate a Phase I/II clinical study of AMT-260 in the second half of 2023”
What we found
Evidence strength A What the grades mean
While the company submitted the IND in 2023, it did not initiate the Phase I/II clinical study of AMT-260 until after the second half of 2023, with initiation expected in 2024.
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A uniQure N.V. 8-K filed 2024-02-28
“Initiation of Phase I/II clinical trials in mesial temporal lobe epilepsy (mTLE) and Fabry disease, in addition to SOD1-ALS, are expected in the first half of 2024” ✓ confirmed on the page
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A uniQure N.V. 10-K filed 2024-02-28
“On September 5, 2023 we announced that the FDA had cleared the IND application for AMT-260.” ✓ 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 DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Regulatory filing
- Indicative materiality
- Medium rules
- Action
- Submit
- Deliverable
- AMT-260 IND and Phase I/II study
- Language
- Expected (“expects”, “plans”)
- 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: disagreesClaude (Anthropic) re-read the evidence blind and read it as “Partly met”.
- Tie-breakA stronger model read the evidence and both earlier answers, without knowing which was recorded, and agrees with the second check.
Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. How verification works
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Report an error in this entry Reference: KI-C-2023-QURE-001826 · Corrections policy