File for approval of ULTOMIRIS SC formulation and device combination in the U.S. and EU

No public evidence found either way

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: 29 Oct 2020
Due: 30 Sep 2021
Last checked: 21 Oct 2026

Deadline
Met
Late
Not met
Today

What the company said

“Alexion plans to file for approval in the U.S. and EU for the ULTOMIRIS SC formulation and device combination in PNH and aHUS in the third quarter of 2021.”

SourceAlexion Pharmaceuticals Form 8-K press release, 2020-10-29
FilingSEC filing index
Deadline as statedin the third quarter of 2021
Deadline used30 Sep 2021, the last day of the stated period
TypeRegulatory
Permanent referenceKI-C-2020-C899866-019404
Cite as https://keptindex.org/c/KI-C-2020-C899866-019404/ — this address never changes.

What we found

After 4 checks we found no clear public record either way, so this commitment is not counted as met or not met.

If you have a public source showing the outcome, please send it to us.

Commitment lineage

Every time the company restated this commitment. The original is never changed, and the outcome is always measured against version 1.

1 versions

Version 1 · original · stated 29 Oct 2020

Deadline 30 Sep 2021 (“in the third quarter of 2021”) · wording expected
Version 2 · stated 30 Apr 2021

Deadline 31 Mar 2022 (“in the first quarter of 2022”)

“and in the EU in the first quarter of 2022.”
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 other
Indicative materiality: Medium rules
Action: File
Deliverable: Approval filing for ULTOMIRIS SC formulation
Where: U.S. and EU
Language: Expected (“expects”, “plans”)
In the company’s control: Medium
Specificity: High
Conditional: Yes: Pending collection of 12-month safety and drug-device combination data
Depends on: Regulatory

How this entry was checked

Commitment recordedThe company's words were matched word for word against the filing.
First checkAn AI model 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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