Welcome to our dedicated page for Aurinia Pharmace news (Ticker: AUPH), a resource for investors and traders seeking the latest updates and insights on Aurinia Pharmace stock.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) news covers the company’s progress as a biopharmaceutical issuer focused on therapies for autoimmune diseases with high unmet medical needs. Investors and followers of AUPH can use this page to review company‑issued updates, financial announcements and clinical data disclosures that shape the outlook for its products and pipeline.
News releases from Aurinia frequently highlight commercial performance and medical data for LUPKYNIS (voclosporin), which the company describes as the first FDA‑approved oral therapy for adult patients with active lupus nephritis. Regular quarterly earnings announcements detail trends in net product sales of LUPKYNIS, license, collaboration and royalty revenue, net income and cash flows. These updates are often accompanied by guidance ranges for total revenue and net product sales, as well as information on the company’s share repurchase plan.
In addition to financial results, Aurinia’s news flow includes clinical and scientific milestones. The company has reported post‑hoc analyses from the AURORA 1 trial, real‑world data from the ENLIGHT‑LN registry and new mechanistic findings on voclosporin, often presented at major rheumatology and nephrology meetings. Separate announcements describe progress with aritinercept (AUR200), a dual BAFF and APRIL inhibitor, including Phase 1 study results and plans for further clinical development in autoimmune diseases.
Visitors to this AUPH news page can review a stream of earnings releases, pipeline updates, medical conference presentations and regulatory‑related communications drawn from company press releases and SEC‑referenced materials. This provides a centralized view of how Aurinia communicates its commercial performance, clinical findings and strategic steps in autoimmune disease drug development.
Aurinia Pharmaceuticals (AUPH) announced the suspension of its Phase 2/3 AUDREY™ clinical trial for voclosporin ophthalmic solution (VOS) aimed at treating dry eye syndrome. The trial failed to meet its primary endpoint, showing no significant improvement compared to the vehicle. A total of 508 participants were enrolled, with results indicating minimal efficacy across various dosages. Despite this setback, Aurinia remains focused on advancing voclosporin for lupus nephritis, which has a different formulation and a PDUFA date approaching. Further analysis of trial data is ongoing.
Aurinia Pharmaceuticals (NASDAQ:AUPH) has initiated the VOCOVID study, an open-label trial to evaluate the antiviral effects of voclosporin in kidney transplant recipients with COVID-19. Conducted at Leiden University Medical Center, the trial compares voclosporin to tacrolimus in terms of viral load reduction over 56 days. Preclinical data suggest voclosporin may inhibit SARS-CoV-2 at a lower concentration than tacrolimus. The study targets 20 participants, assessing safety and viral clearance markers, as it prepares for potential FDA approval of voclosporin for lupus nephritis treatment.
Aurinia Pharmaceuticals (Nasdaq:AUPH) presented promising integrated efficacy and pharmacokinetic data for voclosporin in lupus nephritis from its AURA-LV and AURORA trials at ASN Kidney Week 2020. The study involved 534 patients, revealing that voclosporin combined with mycophenolate mofetil and low-dose steroids achieved superior renal response rates of 43.7% compared to 23.3% for the control group. The FDA has accepted the NDA for voclosporin, with a PDUFA target date of January 22, 2021, suggesting potential market entry for this treatment.
Aurinia Pharmaceuticals has launched a groundbreaking lupus nephritis awareness campaign called Time Is Nephrons. This initiative targets healthcare professionals to promote early diagnosis and screening, aiming to improve kidney function outcomes for patients. Chief Medical Officer Neil Solomons emphasized the urgency in addressing subtle symptoms to prevent severe kidney damage. The company continues to push for FDA approval of voclosporin for lupus nephritis, highlighting its commitment to addressing high unmet medical needs in this area.
Aurinia Pharmaceuticals (NASDAQ:AUPH) announced the granting of non-qualified stock options to nine new employees, allowing them to purchase a total of 96,000 common shares at an exercise price of $14.73 per share, the market's closing price on September 30, 2020. One-third of the options will vest in October 2021, with the remainder vesting in monthly increments thereafter. The options have a ten-year term and adhere to Nasdaq and TSX regulations. Aurinia is focused on developing therapies for serious diseases, including lupus nephritis and dry eye syndrome.
Aurinia Pharmaceuticals (NASDAQ: AUPH) announced the completion of the last patient visit in the Phase 2/3 AUDREY™ clinical study for voclosporin ophthalmic solution (VOS), targeting dry eye syndrome (DES). The study enrolled 509 subjects and compared VOS with a vehicle over 12 weeks. Promising efficacy results were previously noted against Restasis®. Top-line results are expected in Q4 2020, highlighting VOS's potential as a leading calcineurin inhibitor in ophthalmic treatments.