other material
confidence high
sentiment positive
materiality 0.80
Ionis and Roche report positive Phase 3 interim data for sefaxersen in IgAN
IONIS PHARMACEUTICALS INC
- Phase 3 IMAgINATION met primary endpoint: sefaxersen reduced proteinuria (UPCR) vs placebo at 37 weeks, statistically significant and clinically meaningful.
- Safety consistent with prior data, no new signals; study continues blinded to week 105 eGFR assessment.
- 459 patients enrolled, randomized 1:1; sefaxersen is once-monthly subcutaneous self-administered injection.
- Interim data to be presented at medical meeting and shared with health authorities to expedite potential approval.
- Ionis eligible for regulatory/sales milestones and tiered royalties on net sales from Roche license.