The U.S. Food & Drug Administration (FDA) Approves Updated LUPKYNIS® (voclosporin) Label to include Long-Term Data from the AURORA Clinical Program
Aurinia Pharmaceuticals Inc - Common Shares (AUPH)
Last aurinia pharmaceuticals inc - common shares earnings: 3/5 04:02 pm
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Source: Business Wire
New data showing sustained complete renal response with LUPKYNIS through three yearsMonthly kidney function assessment no longer required after first year of treatmentSafety profile remains unchanged and is aligned with the safety findings in the AURORA clinical program ROCKVILLE, Md. & EDMONTON, Alberta--(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 t
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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