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Ionis announces positive interim data from partner Roche’s Phase 3 IMAgINATION study in IgA nephropathy (IgAN)

Key Takeaway: Ionis Pharmaceuticals and Roche reported positive interim results from the Phase 3 IMAgINATION study of sefaxersen in adults with IgA nephropathy. The investigational treatment achieved significant improvements in proteinuria reduction compared to placebo at 37 weeks. This marks a successful milestone for the ongoing clinical trial.

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POSITIVE FACTORS

  • Positive interim results from the Phase 3 study.
  • Sefaxersen showed statistically significant improvements.
  • The study met its primary endpoint successfully.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+3%
120-day peak, hindsight
Typical move
3.7%
average across 15 past catalysts
Lead asset
ISIS 416858
Phase 2 · End-stage Renal Disease (ESRD)

Full Press Release Details

CARLSBAD, Calif.--(BUSINESS WIRE)--Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) and partner Roche today announced positive prespecified interim results from the ongoing Phase 3 IMAgINATION study evaluating investigational sefaxersen in adults with primary IgA nephropathy (IgAN). The study met its primary endpoint with sefaxersen achieving statistically significant and clinically meaningful improvements in proteinuria reduction, compared to placebo at 37 weeks, as measured by 24-hour urine protein

Frequently Asked Questions

What is the IMAgINATION study?

The IMAgINATION study is a Phase 3 clinical trial evaluating sefaxersen for IgA nephropathy.

What were the results of the interim analysis?

The interim analysis showed significant improvements in proteinuria reduction with sefaxersen.

Who are the partners in this study?

Ionis Pharmaceuticals and Roche are the partners conducting the IMAgINATION study.

What is the primary endpoint of the study?

The primary endpoint was met with statistically significant proteinuria reduction compared to placebo.

Last updated: Sep 23, 2026