The U.S. Food & Drug Administration (FDA) Approves Updated LUPKYNIS® (voclosporin) Label to include Long-Term Data from the AURORA Clinical Program [Yahoo! Finance]
Aurinia Pharmaceuticals Inc - Common Shares (AUPH)
Last aurinia pharmaceuticals inc - common shares earnings: 3/5 04:02 pm
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Source: Yahoo! Finance
Safety profile remains unchanged and is aligned with the safety findings in the AURORA clinical program ROCKVILLE, Md. & EDMONTON, Alberta, April 30, 2024 BUSINESS WIRE )--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that the FDA has approved a label update for LUPKYNIS. The updated label no longer includes language indicating that the safety and efficacy of LUPKYNIS has not been established beyond one year. The label now includes three-year data from the AURORA 2 double-blind, placebo-controlled extension study, which assessed the long-term safety and tolerability of LUPKYNIS in combination with mycophenolate mofetil (MMF) and low-dose glucocorticoids, compared with MMF and low-dose glucocorticoids alone, in adults with active lupus nephritis (LN) who completed the Phase 3 AURORA 1 clinical trial. A post hoc analysis of data from the extension study now included in the label showed that, among the 179 patients receiving LUPKYNIS and 178 pa
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AUPH
News
- Analysis Showing LUPKYNIS® is a Cost-Effective Treatment for Lupus Nephritis Presented at National Kidney Foundation's Spring Clinical Meeting 2024 [Yahoo! Finance]Yahoo! Finance
- Analysis Showing LUPKYNIS® is a Cost-Effective Treatment for Lupus Nephritis Presented at National Kidney Foundation’s Spring Clinical Meeting 2024Business Wire
- Aurinia Presents Data Reinforcing LUPKYNIS® Safety and Efficacy for People with Lupus Nephritis at Congress of Clinical Rheumatology East 2024 [Yahoo! Finance]Yahoo! Finance
- Aurinia Presents Data Reinforcing LUPKYNIS® Safety and Efficacy for People with Lupus Nephritis at Congress of Clinical Rheumatology East 2024Business Wire
- Aurinia Pharmaceuticals Shareholder Urges Board of Directors to Take Action to Enhance Shareholder Value [Yahoo! Finance]Yahoo! Finance
AUPH
Earnings
- 5/2/24 - Beat
AUPH
Sec Filings
- 5/3/24 - Form ARS
- 5/3/24 - Form DEFA14A
- 5/3/24 - Form DEF
- AUPH's page on the SEC website