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Orphazyme A/S

Report top-line results from the Phase 3 amyotrophic lateral sclerosis (ALS) trial

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

“Top-line results H1 2021 Inclusion Body Myositis Top-line results H1 2021”

What we found

Evidence strength A What the grades mean

Filings state top-line results from the ALS pivotal trial were announced in May 2021, within H1 2021, and the trial missed its primary and secondary endpoints.

  • 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
    “Announced top-line results from both the Phase 2/3 trial of arimoclomol in Inclusion Body Myositis and the Phase 3 trial of arimoclomol in Amyotrophic Lateral Sclerosis; neither trial met its primary endpoint” ✓ 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 May 2021, it was announced, the ORARIALS-01 pivotal trial of arimoclomol in amyotrophic lateral sclerosis (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
Top-line results from ALS trial
In the company’s control
Medium
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, 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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