Roche, Ionis RNA Drug Sefaxersen Hits Phase 3 Goal in IgA Nephropathy

Roche and Ionis Pharmaceuticals said on September 23, 2026, that their experimental IgA nephropathy drug sefaxersen met its primary endpoint in a Phase 3 trial at an interim analysis, showing statistically significant and clinically meaningful reductions in urinary protein, a key marker of kidney health. Full data will be presented at a future medical meeting and shared with regulators; participants will be followed for two years. If approved, the monthly self-injected antisense oligonucleotide would compete with Novartis' Fabhalta, a twice-daily pill, alongside recent accelerated approvals from Otsuka and Vera Therapeutics. Existing IgA nephropathy therapies are priced around $400,000 to $500,000 annually. Analysts view sefaxersen as underappreciated within Roche's pipeline, potentially lifting earnings alongside giredestrant and fenebrutinib. Ionis stands to receive up to $400 million in milestone payments plus sales royalties.