Welcome to our dedicated page for Aurinia Pharmaceuticals news (Ticker: AUPH), a resource for investors and traders seeking the latest updates and insights on Aurinia Pharmaceuticals stock.
Aurinia Pharmaceuticals Inc (symbol: AUPH) is a cutting-edge biopharmaceutical company headquartered at 5120-75 street, Edmonton, Canada. Specializing in the treatment of serious diseases with high unmet medical need, Aurinia is committed to providing innovative therapeutic solutions to patients worldwide. The company's flagship product, LUPKYNIS (voclosporin), is an investigational drug designed for the treatment of lupus nephritis (LN), a severe renal complication of lupus. This groundbreaking treatment underscores Aurinia's focus on developing life-changing medications.
In recent years, Aurinia Pharmaceuticals has made significant strides in its research and development efforts, particularly in the United States, where it derives the majority of its revenue. The company has forged strategic partnerships with leading healthcare organizations and continues to explore new avenues for growth and innovation.
Financially, Aurinia has demonstrated strong performance, with consistent revenue growth driven by its robust pipeline of investigational drugs. The company's commitment to advancing its clinical programs and securing regulatory approvals positions it well for sustained success in the biopharmaceutical industry.
With a dedicated team of experts and a clear vision for the future, Aurinia Pharmaceuticals is poised to make a lasting impact on global healthcare. Investors and stakeholders can stay updated on the latest developments, financial results, and strategic initiatives through the company's regular news updates and investor relations communications.
Aurinia Pharmaceuticals (NASDAQ: AUPH) welcomes the American College of Rheumatology's (ACR) 2024 guidelines for lupus nephritis (LN) treatment. The new guidelines recommend LUPKYNIS as first-line therapy in a triple immunosuppressive treatment regimen. Key highlights include steroid tapering to <5 mg/day by six months and achieving proteinuria target of <0.5g/g UPCR by 12 months. The AURORA 1 clinical study showed patients were 81% more likely to achieve complete renal response at 52 weeks with LUPKYNIS combination therapy versus standard treatment. Notably, >80% of patients reached steroid doses of <2.5mg/day by 16 weeks.
Aurinia Pharmaceuticals (NASDAQ: AUPH) presented four posters at ACR 2024, highlighting new data about lupus nephritis (LN) detection and LUPKYNIS® treatment. A key study using the American Rheumatology Network database revealed that 62% of 8,631 SLE patients showed signs suggesting LN, yet many weren't receiving proper kidney screenings. The analysis of Phase 3 AURORA 1 and 2 studies demonstrated significantly higher rates of sustained complete renal response in LUPKYNIS patients compared to placebo. The data emphasizes the need for enhanced LN screening and validates LUPKYNIS's long-term efficacy in treating active LN in adults.
Aurinia Pharmaceuticals (NASDAQ: AUPH) announced its participation in the upcoming Jefferies Healthcare Conference in London, scheduled for November 19-21, 2024. The company's management team will engage in one-on-one meetings with investors and participate in a fireside chat and Q&A session on Wednesday, November 20, at 12:00 PM GMT/7:00 AM EST. The session will not be webcasted.
Aurinia Pharmaceuticals (NASDAQ: AUPH) has appointed Craig Johnson to its Board of Directors to support its next phase of growth. Johnson brings over 30 years of experience in senior financial management and governance roles in the biotechnology industry. He has previously served as director at multiple biotech companies including Ardea Biosciences, Adamis Pharmaceuticals, and Mirati Therapeutics, and currently serves as director at Heron Therapeutics. The company also announced the retirement of Dr. Robert T. Foster from the Board.
Aurinia Pharmaceuticals reported strong Q3 2024 results with total net revenue of $67.8 million (24% YoY growth) and net product revenue of $55.5 million (36% YoY growth). The company generated $17.0 million in operating cash flow and maintained $348.7 million in cash and investments. Aurinia announced a strategic restructuring, reducing workforce by 45%, expecting $40 million in annual operating expense savings with a one-time charge of $15-19 million in Q4. The company reaffirmed its 2024 net product revenue guidance of $210-220 million and reported 2,422 patients on LUPKYNIS therapy, representing 25% YoY market penetration growth.
Aurinia Pharmaceuticals (NASDAQ: AUPH) has announced it will release its third quarter 2024 financial and operational results on November 7, 2024, before markets open. The company's management team will host a conference call and webcast at 8:30 am ET on the same day to discuss the results and provide a business update. Interested parties can join via webcast or by dialing (800) 715-9871 / +1 (646) 307-1963 with Conference ID: 6251719.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) announced the acceptance of six abstracts at the American Society of Nephrology (ASN) Kidney Week 2024. The data reinforces the clinical importance of LUPKYNIS® (voclosporin) for treating adults with active lupus nephritis (LN). Key highlights include:
1. New real-world baseline data from ENLIGHT-LN, a U.S.-based registry of LN patients treated with LUPKYNIS, providing insights into its effectiveness and usage patterns.
2. Two studies exploring LUPKYNIS's effects on podocytes in LN and idiopathic nephrotic syndrome, showing enhanced podocyte cytoskeletal stability at lower concentrations compared to older treatments.
3. LUPKYNIS demonstrated significant improvements in proteinuria, hypercoagulability, lipid profiles, and cell viability in a preclinical model of idiopathic nephrotic syndrome.
These findings highlight LUPKYNIS's role in preserving kidney function and differentiate it from first-generation calcineurin inhibitors.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) announced that the Japanese Ministry of Health, Labour, and Welfare has approved voclosporin in combination with mycophenolate mofetil (MMF) to treat lupus nephritis (LN). This approval is based on data from the AURORA Clinical Program, which included a 12-month Phase 3 study and a two-year extension study.
The company's collaboration partner, Otsuka Pharmaceutical Co., , filed the new drug application in November 2023. As part of their agreement, Aurinia is eligible to receive a $10 million payment upon approval in Japan, along with low double-digit royalties on net sales. Aurinia will supply the product to Otsuka on a cost-plus basis.
Voclosporin, marketed as LUPKYNIS in the U.S., was previously approved by the FDA in January 2021 for treating adult patients with active LN.
Aurinia Pharmaceuticals (NASDAQ: AUPH) announced its participation in the 2024 Cantor Fitzgerald Global Healthcare Conference in New York City from September 17-19, 2024. The company's management team will:
- Host one-on-one meetings with investors
- Participate in a fireside chat and Q&A session on Tuesday, September 17th, at 3:05 PM EDT
A live webcast of the session will be available on the Investor section of Aurinia's website. This conference provides an opportunity for Aurinia to engage with investors and showcase its developments in the healthcare sector.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) has restructured its Board of Directors to align with shareholder interests. Key changes include:
1. Peter Greenleaf, President and CEO, remains a Director despite receiving less than majority support at the 2024 Annual General Meeting.
2. Kevin Tang, President of Tang Capital Management, , appointed as a new Director.
3. The Board accepted conditional resignations of three directors who received less than majority support: Daniel G. Billen, R. Hector MacKay-Dunn, and Brinda Balakrishnan.
4. The restructured Board now consists of seven members, focusing on commercial execution, free cash flow generation, and pipeline advancement.
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