Ionis Pharmaceuticals: Roche reports 43.1% proteinuria reduction

What happened

• On Oct 23, 2026 Ionis issued a press release reporting that its partner Roche announced late-breaking oral presentation data from the ongoing Phase 3 IMAgINATION study in adults with primary IgA nephropathy receiving optimized standard of care. Roche reported that investigational sefaxersen achieved a 43.1% reduction in proteinuria (95% confidence interval [CI]: 32.5 - 52.0, P<0.0001) relative to placebo at 37 weeks, as measured by 24-hour urine protein-to-creatinine ratio (UPCR).

Key details

• Data announced at American Society of Nephrology Kidney Week 2026 included greater hematuria resolution at Week 37 among patients with baseline hematuria.
• The filing says the treatment effect was consistent across all prespecified subgroups and that sefaxersen was well tolerated with a safety profile consistent with the previously reported Phase 2 study.
• The IMAgINATION study will continue as a blinded study to evaluate change in kidney function over 2 years, measured by estimated glomerular filtration rate at week 105.
• Ionis says Roche licensed sefaxersen from Ionis; Ionis received an upfront payment, a license fee and development milestone payments and is eligible for regulatory and sales milestone payments and tiered royalties on net sales.

Why it may matter

• The filing reports Item 7.01 (Regulation FD disclosure) and Item 8.01 (other events), which cover public disclosure of clinical trial results and related program updates. This filing does not show why the insider traded or why the company acted.