Kezar Life Sciences Inc. shares (NASDAQ:KZR) rose 37%, or $3.18, to close Nov. 16 at $11.59 on interim results from the phase II part of the study called Mission, testing KZR-616, a first-in-class selective immunoproteasome inhibitor, in patients with active, proliferative lupus nephritis (LN).
Aurinia Pharmaceuticals Inc. got its first drug approval with the FDA’s nod to Lupkynis (voclosporin) for treating active lupus nephritis in adults. It’s the first FDA-approved oral therapy for the indication and the second approval in little more than a month for those patients, following the agency’s Dec. 17 approval of Glaxosmithkline plc’s Benlysta (belimumab), for treating active LN.
New updates from a dynamic late-phase systemic lupus erythematosus pipeline shared at this week's American College of Rheumatology annual meeting and beyond showed a robust field of potential new treatments nearing the finish line.
Aurinia Pharmaceuticals Inc. is suspending further development of voclosporin ophthalmic solution (VOS) for dry eye syndrome after a dose-ranging trial of the candidate failed to meet its primary endpoint of improving a measure of the condition after four weeks of treatment.
Shares of Equillium Inc. (NASDAQ:EQ) closed at $4.75, up 69 cents, or 17%, after trading as high as $5.25 as Wall Street hailed the FDA’s granting of fast track status to itolizumab – the first clinical-stage anti-CD6 therapy – for the treatment of lupus nephritis (LN).
In the summer of 2016, when Victoria, British Columbia-based Aurinia Pharmaceuticals Inc. offered phase IIb results with its calcineurin inhibitor voclosporin in lupus nephritis (LN), Wall Street ignored the otherwise-positive results and zeroed in on the trial’s death rate: 13 casualties across three arms of the 265-subject Aura-LV study.
