ROCKVILLE, Md. & EDMONTON, Alberta - Aurinia Pharmaceuticals Inc. (NASDAQ: NASDAQ:AUPH), a biopharmaceutical company, announced today that its drug voclosporin, in combination with mycophenolate mofetil (MMF), has been approved by the Japanese Ministry of Health, Labour, and Welfare for the treatment of lupus nephritis (LN), a severe autoimmune disease affecting the kidneys.
This regulatory milestone follows the new drug application submitted in November 2023 by Aurinia's partner, Otsuka Pharmaceutical Co., Ltd., and is supported by data from the AURORA Clinical Program. The program consists of a 12-month Phase 3 study and a two-year extension study, which evaluated the efficacy and safety of voclosporin combined with MMF and low-dose glucocorticoids.
Peter Greenleaf, President and CEO of Aurinia, expressed enthusiasm for the approval, highlighting the high incidence of lupus nephritis among Japanese patients and the significant unmet medical need this approval addresses.
Under a December 2020 agreement, Aurinia partnered with Otsuka for the development and commercialization of voclosporin in various regions, including Japan. Aurinia will receive a $10 million payment for the Japanese approval and low double-digit royalties on net sales post-launch. The company will also provide the product to Otsuka under a commercial supply agreement.
Voclosporin, marketed as LUPKYNIS, was approved by the U.S. Food and Drug Administration (FDA) in January 2021 for the treatment of adult patients with active LN. The medication is a second-generation calcineurin inhibitor that acts as an immunosuppressant and promotes stability in the kidney's podocytes.
Lupus nephritis is a manifestation of systemic lupus erythematosus (SLE), affecting approximately 120,000 individuals in the U.S. Medical guidelines recommend routine LN screenings for all SLE patients due to the severe consequences of delayed diagnosis.
The safety information for LUPKYNIS includes warnings about the increased risk of malignancies and serious infections, nephrotoxicity, hypertension, neurotoxicity, hyperkalemia, and QTc prolongation. It is contraindicated in patients taking strong CYP3A4 inhibitors and those with severe hypersensitivity to the drug or its components.
This article is based on a press release statement from Aurinia Pharmaceuticals Inc.
In other recent news, Aurinia Pharmaceuticals has undergone significant changes in its Board of Directors, retaining Peter Greenleaf and appointing Kevin Tang, while accepting the resignations of Daniel G. Billen, R. Hector MacKay-Dunn, and Brinda Balakrishnan. These changes come in response to shareholder concerns and aim to better align with shareholder interests. In addition, the company has initiated a Phase 1a single ascending dose study for AUR200, a new treatment candidate for autoimmune diseases, as per the third-quarter guidance. H.C. Wainwright has reiterated a Buy rating on the company's shares, acknowledging this significant advancement in Aurinia's clinical pipeline.
In other developments, shareholder Lucien Selce, who holds approximately 2.2% of Aurinia's shares, has called for further changes to the board and an Extraordinary General Meeting. His demands are due to concerns about the company's financial management and the inconsistent strategy regarding the development of AUR200. Meanwhile, Aurinia reported improved outcomes in lupus nephritis therapy during the European Alliance of Associations for Rheumatology (EULAR) 2024, showing that a treatment regimen including LUPKYNIS was more effective than traditional high-dose glucocorticoid therapies. These are the recent developments in Aurinia Pharmaceuticals.
InvestingPro Insights
Following the recent approval of Aurinia Pharmaceuticals Inc.'s (NASDAQ: AUPH) drug voclosporin in Japan, the company's financial health and stock performance come into focus for investors. Aurinia's proactive approach to capital management is evident through its aggressive share repurchase strategy, as noted in one of the InvestingPro Tips. This could signal confidence from management in the company's future prospects.
Moreover, Aurinia's financial position appears robust, with the company holding more cash than debt on its balance sheet, a reassuring sign for investors concerned about financial stability. This is further supported by the fact that the company's liquid assets exceed its short-term obligations, as highlighted by another InvestingPro Tip. These insights suggest that Aurinia is well-positioned to manage its financial obligations in the near term.
From a performance standpoint, Aurinia has demonstrated strong returns over the last three months, with a price total return of 23.32%. This momentum is also reflected in a significant six-month price total return of 40.44%. However, it's worth noting that the company has not been profitable over the last twelve months, which is a critical consideration for potential investors.
InvestingPro Data indicates a market capitalization of approximately $998.08 million USD, with a negative P/E ratio, reflecting the company's current lack of profitability. Despite these challenges, analysts predict that Aurinia will turn profitable this year, which could be a pivotal moment for the company.
For those looking to delve deeper into Aurinia's prospects, including additional InvestingPro Tips related to the company's performance and valuation metrics, they can explore further on the InvestingPro platform, where a total of 9 tips are available for Aurinia Pharmaceuticals Inc. at https://www.investing.com/pro/AUPH.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.