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Orchard Therapeutics plc

Launch Libmeldy in the EU

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
11 Jan 2021
Due
30 Jun 2021
Checked
24 Oct 2026
  • Deadline
  • Met
  • Late
  • Not met
  • Today

What the company said

“Launch Libmeldy for the treatment of eligible patients with early-onset MLD in the EU in the first half of 2021.”

What we found

Evidence strength A What the grades mean

While Libmeldy was approved in December 2020, the company indicated in August and November 2021 that it had not yet begun generating revenue or commercial sales in the EU by the deadline.

  • A
    Orchard Therapeutics plc 10-Q filed 2021-08-04 Regulatory filing · published 4 Aug 2021 · retrieved 24 Oct 2026 · kept permanently by the SEC · fingerprint 49c465efaa0c
    “Libmeldy received approval from the European Commission in December 2020 and, if we are able to identify patients and secure reimbursement for our treatment, we may begin to generate revenue from the sale of Libmeldy in Europe in 2021.” ✓ confirmed on the page
  • A
    Orchard Therapeutics plc 10-Q filed 2021-11-04 Regulatory filing · published 4 Nov 2021 · retrieved 24 Oct 2026 · kept permanently by the SEC · fingerprint 68d8a86b5f1c
    “Libmeldy received approval from the European Commission in December 2020 and, if we are able to identify patients and secure reimbursement for our treatment, we may begin to generate revenue from the sale of Libmeldy in Europe in 2021 or early 2022.” ✓ confirmed on the page

Checked 24 Oct 2026.

Commitment DNA

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

Event type
Commercial launch
Indicative materiality
Medium rules
Action
Launch
Deliverable
Libmeldy launch
Where
EU
In the company’s control
High
Specificity
High

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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