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Orphazyme A/S

Report topline data from pivotal arimoclomol studies in ALS and IBM

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
2 Mar 2021
Due
30 Jun 2021
Delivered
May 2021
  • Deadline
  • Met
  • Late
  • Not met
  • Today

What the company said

“Topline data read-outs from pivotal studies of arimoclomol in ALS and IBM in H1 2021”

What we found

Evidence strength A What the grades mean

Topline results for both pivotal trials were announced within H1 2021: the IBM trial in March 2021 and the ALS trial in May 2021. Both results were negative.

  • A
    Orphazyme A/S 6-K filed 2021-08-31 Regulatory filing · published 31 Aug 2021 · retrieved 27 Oct 2026 · kept permanently by the SEC
    “Topline data were presented at the virtual European Network to Cure ALS (ENCALS) meeting in May 2021” ✓ confirmed on the page
  • A
    Orphazyme A/S 6-K filed 2021-08-31 Regulatory filing · published 31 Aug 2021 · retrieved 27 Oct 2026 · kept permanently by the SEC
    “In May 2021, Orphazyme announced that the Phase 3 ORARIALS-01 pivotal trial of arimoclomol in ALS did not meet its primary and secondary endpoints.” ✓ confirmed on the page
  • A
    Orphazyme A/S 20-F filed 2022-06-28 Regulatory filing · published 28 Jun 2022 · retrieved 27 Oct 2026 · kept permanently by the SEC
    “In March 2021, we announced that our Phase 2/3 trial in IBM did not meet its primary and secondary endpoints, and in May 2021 we announced that our Phase 3 trial in ALS did not meet its primary and secondary endpoints.” ✓ confirmed on the page

Checked 27 Oct 2026.

Commitment DNA

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

Event type
Clinical readout late
Indicative materiality
High rules
Action
Report
Deliverable
Topline data from pivotal arimoclomol studies in ALS and IBM
In the company’s control
Medium
Specificity
Medium

How this entry was checked

  1. Commitment recordedThe company's words were matched word for word against the filing.
  2. First checkAn AI model, Claude (Anthropic), read the company's later filings and recorded the outcome with a quoted passage.

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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