Roche and Ionis sefaxersen: the interim kidney endpoint and the long-term test

Last updated (page presentation): 10 Oct 2026, 07:39 UTC. Page presentation only; original policy, publication and source-review dates remain unchanged. Data checks and service status retain their own verification times.

One clinical update reaches two companies through a licensing relationship. ORION connects the partner disclosures to the same trial while keeping a surrogate endpoint distinct from the later kidney-function outcome.

ORION editorial research · Published 23 Sep 2026 · Source announcement 23 Sep 2026 · Evidence reviewed 2026-09-23

Company claims are attributed to the dated sources below. ORION’s editorial checklist is explained in Coverage & method.

01 / SOURCE RECORD

What is confirmed

Roche and Ionis each announced on 23 September that the ongoing IMAgINATION Phase 3 study met its prespecified interim primary endpoint: reduction in proteinuria versus placebo at week 37, measured by urine protein-to-creatinine ratio.
Roche said it licensed sefaxersen from Ionis. Ionis disclosed eligibility for regulatory and sales milestones and tiered royalties; the announcement does not establish that future payments have been earned.
The blinded study continues to evaluate change in kidney function by estimated glomerular filtration rate at week 105. An interim proteinuria result is not that later result.

Verify these points in the linked primary sources. Source language and numbers may be updated later; this page captures the dated release.

02 / INTERPRETATION

How we read the change

The event strengthens the case that sefaxersen affects the measured surrogate endpoint. The more consequential question is whether the later kidney-function evidence supports a durable clinical benefit.

What would change our view?

A supportive long-term kidney-function result would strengthen the clinical interpretation; a disconnect between proteinuria and eGFR would materially limit it.

03 / NEXT CHECK

Questions to revisit

What detailed effect size and safety data are presented at the medical meeting?
What does the week-105 eGFR analysis show after longer blinded follow-up?
Which regulatory actions, if any, follow from the interim evidence?

04 / EVIDENCE

Open the primary sources

Source review date: 2026-09-23. Open the complete issuer and registry materials at their original URLs.