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. (AUPH) is a biopharmaceutical innovator developing therapies for autoimmune diseases with high unmet needs, including lupus nephritis. This page aggregates all company announcements, clinical trial updates, and regulatory developments.
Investors and healthcare professionals will find real-time access to earnings reports, partnership disclosures, and research milestones. Key coverage areas: FDA submissions, therapy commercialization progress, and scientific collaboration updates related to LUPKYNIS and pipeline candidates.
Bookmark this resource for verified information directly from corporate communications and curated third-party analysis. Check regularly for developments impacting Aurinia's position in autoimmune treatment markets.
Aurinia Pharmaceuticals has received FDA approval for LUPKYNIS (voclosporin), the first oral therapy for treating adult patients with active lupus nephritis (LN). This innovative treatment significantly improves renal response rates and accelerates decreases in urine protein levels compared to standard therapies. Clinical trials indicated that LUPKYNIS is more than twice as effective at achieving complete renal response. Aurinia has initiated the Aurinia Alliance program to support patients. This approval is a significant advancement for the lupus community, addressing a critical unmet need.
Aurinia Pharmaceuticals (NASDAQ: AUPH) announced that its management will participate in upcoming virtual investor conferences. Key events include an on-demand fireside chat at the H.C. Wainwright Virtual BioConnect 2021 Conference starting January 11, 2021, at 6:00 a.m. EST, and a panel discussion led by Dr. Scott Gottlieb at 12:00 p.m. EST on the same day. Additionally, a fireside chat at the J.P. Morgan 39th Annual Healthcare Conference is scheduled for January 14, 2021, at 4:30 p.m. EST. Interested parties can access the webcasts on Aurinia's corporate website.
Aurinia Pharmaceuticals (NASDAQ: AUPH) has announced a collaboration with Otsuka Pharmaceutical Co., Ltd. for the development of oral voclosporin, aimed at treating Lupus Nephritis (LN) in multiple regions including the EU and Japan. Aurinia will receive an upfront payment of $50 million, with potential milestone payments of up to $50 million and tiered royalties on net sales ranging from 10% to 20%. Otsuka plans to file for marketing authorization in the EU in Q2 2021. This agreement underscores Aurinia's goal to expand access to voclosporin globally for LN patients.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) announced its participation in the Piper Sandler 32nd Annual Virtual Healthcare Conference. Presentations will be accessible to registered attendees until December 3. Interested parties can listen to the audio webcast by registering through the 'Investors' section of Aurinia's website. A replay will be available for 30 days. Aurinia focuses on developing therapies for serious diseases with high unmet medical needs, including seeking FDA approval for voclosporin for lupus nephritis treatment.
Aurinia Pharmaceuticals (NASDAQ:AUPH) announced the grant of a non-qualified stock option for 298,924 common shares to newly appointed Executive Vice President, Stephen Robertson. The options, with an exercise price of $13.40 per share, will vest in phases beginning November 2021. This grant complies with Nasdaq Listing Rule 5635(c)(4) and the TSX regulations. Aurinia is focused on developing therapies for high unmet medical needs, particularly voclosporin for lupus nephritis.
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.