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. reports news centered on its autoimmune-disease biopharmaceutical business, led by LUPKYNIS (voclosporin), an FDA-approved oral therapy for adult patients with active lupus nephritis. Recurring updates cover product sales, total revenue, license, collaboration and royalty revenue, and business progress tied to commercialization of LUPKYNIS.
Company news also includes pipeline development for aritinercept, a dual BAFF and APRIL inhibitor being developed for autoimmune diseases, as well as collaboration activity with Otsuka, financial guidance, share repurchase activity, executive appointments, board matters and shareholder governance commentary.
Aurinia Pharmaceuticals (NASDAQ: AUPH) announced that its senior management will participate in a fireside chat at the 2020 Jefferies Virtual London Healthcare Conference on November 19, 2020, at 11:25 a.m. ET. Interested parties can access the live audio webcast through the 'News/Events' section on Aurinia's corporate website. A replay will also be available. Aurinia Pharmaceuticals is focused on developing therapies for serious diseases with high unmet medical needs, currently seeking FDA approval for voclosporin to treat lupus nephritis.
Aurinia Pharmaceuticals reported its Q3 2020 financial results, showing a net loss of $34.1 million or $0.28 per share, compared to a loss of $19.0 million in Q3 2019. The company has $421 million in cash resources as of September 30, 2020, up from $306 million at the end of 2019. Its NDA for voclosporin received FDA Priority Review, with a PDUFA date set for January 22, 2021. R&D expenses fell to $4.8 million due to reduced clinical activities, while corporate expenses rose significantly to $31.1 million, reflecting preparations for the voclosporin launch.
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.