Sefaxersen Cuts Proteinuria 43% in Phase III IgA Nephropathy Trial
RHHBY sits 50% above its 52-week low of $40.07.
Summary
Genentech's investigational sefaxersen hit its Phase III primary endpoint in IgA nephropathy, cutting 24-hour urine protein-to-creatinine ratio by 43.1% versus placebo at 37 weeks (P<0.0001) in the 459-patient IMAgINATION study. Patients with baseline hematuria were more likely to have it resolve by Week 37 on sefaxersen, and the safety profile matched Phase II with no new signals. Proteinuria reduction is the accepted surrogate for preserving kidney function, so this is the efficacy bar the drug needed to clear; sefaxersen is a once-monthly self-injected antisense inhibitor of complement factor B, licensed from Ionis. The remaining risk is confirmatory: the study stays blinded to measure eGFR change at week 105, and that kidney-function readout is what regulators will weigh alongside this endpoint. Comes after a strong stretch of Roche news flow — Q3 revenue beat on October 22 and recent US and EU label wins — so the stock is already trading near its 52-week high.
At the time of this announcement, RHHBY was trading at $60.19 on OTC in the Life Sciences sector, with a market capitalization of approximately $380.8B. The 52-week trading range was $40.07 to $61.49. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: BusinessWire.