ROCKVILLE, Md. & EDMONTON, Alberta - Aurinia Pharmaceuticals Inc. (NASDAQ: NASDAQ:AUPH) has announced the acceptance of six abstracts for presentation at the upcoming American Society of Nephrology Kidney Week 2024, taking place from October 23-27 in San Diego, CA. The presentations will focus on the clinical utility of LUPKYNIS (voclosporin), a treatment for adults with active lupus nephritis (LN), highlighting its role in addressing the needs of disproportionately affected populations and its impact on kidney health.
The company's ENLIGHT-LN registry, a U.S.-based observational study, has provided new baseline data from 123 patients with biopsy-confirmed LN who have initiated LUPKYNIS treatment within the past year. This data set includes a significant representation of Black and Hispanic/Latino patients, aligning with the demographic makeup of the larger LN patient population in the U.S.
In addition to the registry data, two new studies have been released. One study compares the effects of LUPKYNIS on podocyte cell biology and biomechanics to older treatments such as cyclosporine A and tacrolimus, suggesting that LUPKYNIS may enhance podocyte cytoskeletal stability at lower concentrations. Another preclinical study indicates that LUPKYNIS could significantly improve proteinuria and other indicators of kidney health in a model of idiopathic nephrotic syndrome, compared to cyclosporine A.
These findings aim to differentiate LUPKYNIS from first-generation calcineurin inhibitors and underscore its importance in preserving kidney function in LN patients.
Lupus nephritis is a severe manifestation of systemic lupus erythematosus, affecting approximately 120,000 people in the U.S., with a higher prevalence among women and people of color. Despite medical guidelines recommending routine LN screenings, research indicates that many SLE patients are not screened, and a majority of those diagnosed with LN remain untreated.
LUPKYNIS is a second-generation calcineurin inhibitor with a dual mechanism of action, approved by the FDA for the treatment of adult patients with active LN in combination with a background immunosuppressive therapy regimen. It is part of the AURORA Clinical Program, which includes three years of LN treatment and follow-up.
Aurinia Pharmaceuticals is dedicated to delivering therapies for autoimmune diseases with high unmet medical needs. The company emphasizes the critical need for routine LN screening and transformative therapies to improve patient outcomes.
This report is based on a press release statement from Aurinia Pharmaceuticals Inc.
In other recent news, Aurinia Pharmaceuticals' lupus nephritis treatment, voclosporin, received approval from the Japanese Ministry of Health, Labour, and Welfare. The approval is based on data from the AURORA Clinical Program, and Aurinia will receive a $10 million payment for the Japanese approval from its partner, Otsuka Pharmaceutical Co., Ltd. Simultaneously, the company has seen changes in its Board of Directors, with Peter Greenleaf retained and Kevin Tang appointed.
The company has also initiated a Phase 1a single ascending dose study for AUR200, a new treatment candidate for autoimmune diseases. This advancement in Aurinia's clinical pipeline was acknowledged by H.C. Wainwright, which reiterated a Buy rating on the company's shares.
However, shareholder Lucien Selce, who holds about 2.2% of Aurinia's shares, has called for further changes to the board due to concerns about the company's financial management and the inconsistent strategy regarding the development of AUR200. These are the recent developments in Aurinia Pharmaceuticals.
InvestingPro Insights
Aurinia Pharmaceuticals Inc.'s (NASDAQ: AUPH) recent announcements regarding LUPKYNIS and its clinical utility are complemented by some intriguing financial insights from InvestingPro. The company's market cap stands at $998.08 million, reflecting investor interest in its potential growth in the lupus nephritis treatment market.
InvestingPro data shows that Aurinia's revenue growth has been robust, with a 29.35% increase over the last twelve months as of Q2 2024. This aligns well with the company's focus on LUPKYNIS and its expanding clinical applications. The quarterly revenue growth is even more impressive at 37.83%, indicating accelerating market adoption of their flagship product.
An InvestingPro Tip highlights that analysts predict the company will be profitable this year. This projection is particularly significant given the company's current investment in research and clinical studies, as evidenced by the multiple abstracts accepted for presentation at the upcoming American Society of Nephrology Kidney Week 2024.
Another relevant InvestingPro Tip notes that Aurinia holds more cash than debt on its balance sheet. This strong financial position is crucial for a biopharmaceutical company investing heavily in research and development, especially as it seeks to differentiate LUPKYNIS from first-generation treatments and expand its applications.
For investors interested in a deeper analysis, InvestingPro offers additional tips and metrics that could provide further insight into Aurinia's financial health and growth prospects. The InvestingPro product includes 7 more tips that could be valuable for understanding the company's potential in the competitive pharmaceutical landscape.
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