Aurinia Pharmaceuticals Inc. has submitted an IND application to the FDA for AUR-200, a potential next-generation therapy for B-cell-mediated autoimmune diseases.
Cyteir Therapeutics Inc. is leading a pack of companies that have taken a hard look at their future and don’t care for what they see. According to BioWorld data, at least 100 biopharma companies have announced restructurings and layoffs this year, resulting in more than 8,400 jobs lost. Other companies either packing it in, restructuring from within or considering new paths include Aurinia Pharmaceuticals Inc., Bellerophon Therapeutics Inc., Calithera Biosciences Inc. and Spexis AG.
Aurinia Pharmaceuticals Inc. has added two potential drugs to its pipeline targeting autoimmune and kidney-related diseases through an acquisition and a licensing deal. Victoria, British Columbia-based Aurinia is building on its first ever FDA approval at the beginning of the year, for Lupkynis (voclosporin) for treating active lupus nephritis in adults.
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.
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.
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.