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. (NASDAQ: AUPH) news covers the company’s progress as a biopharmaceutical issuer focused on therapies for autoimmune diseases with high unmet medical needs. Investors and followers of AUPH can use this page to review company‑issued updates, financial announcements and clinical data disclosures that shape the outlook for its products and pipeline.
News releases from Aurinia frequently highlight commercial performance and medical data for LUPKYNIS (voclosporin), which the company describes as the first FDA‑approved oral therapy for adult patients with active lupus nephritis. Regular quarterly earnings announcements detail trends in net product sales of LUPKYNIS, license, collaboration and royalty revenue, net income and cash flows. These updates are often accompanied by guidance ranges for total revenue and net product sales, as well as information on the company’s share repurchase plan.
In addition to financial results, Aurinia’s news flow includes clinical and scientific milestones. The company has reported post‑hoc analyses from the AURORA 1 trial, real‑world data from the ENLIGHT‑LN registry and new mechanistic findings on voclosporin, often presented at major rheumatology and nephrology meetings. Separate announcements describe progress with aritinercept (AUR200), a dual BAFF and APRIL inhibitor, including Phase 1 study results and plans for further clinical development in autoimmune diseases.
Visitors to this AUPH news page can review a stream of earnings releases, pipeline updates, medical conference presentations and regulatory‑related communications drawn from company press releases and SEC‑referenced materials. This provides a centralized view of how Aurinia communicates its commercial performance, clinical findings and strategic steps in autoimmune disease drug development.
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.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) has announced the dosing of the first participant in a Phase 1a single ascending dose (SAD) study of AUR200, a potential best-in-class therapy for autoimmune diseases. AUR200 targets both BAFF and APRIL, and is believed to be more potent with higher binding affinity compared to similar molecules. The study aims to assess safety, tolerability, pharmacokinetics, and biomarker changes in healthy volunteers, with data expected in the first half of 2025.
Aurinia plans to develop AUR200 for diseases with few market entrants, including one larger indication and one smaller indication meeting FDA criteria for orphan and rare diseases. The company will fund this development using available cash flow, without impacting post-restructuring operating expense targets.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference in New York City from September 9-11, 2024. The company's management team will engage in one-on-one meetings with investors and take part in a fireside chat and Q&A session on Tuesday, September 10, at 10:30 AM EST.
This event provides an opportunity for Aurinia to showcase its developments and interact with potential investors. However, it's worth noting that the fireside chat and Q&A session will not be webcast, limiting access to attendees present at the conference.
Aurinia Pharmaceuticals (NASDAQ: AUPH) shareholder Lucien Selce, owning 2.2% of shares, has called for the resignation of CEO Peter Greenleaf and two other directors following the 2024 Annual General Meeting results. Four of nine directors, including Greenleaf, failed to receive majority votes. Selce criticizes the company's excessive spending, lack of R&D investment, and ineffective strategy. He highlights concerns about LUPKYNIS sales, potential generic competition, and management's disregard for shareholder interests. Selce proposes immediate firm resignations, appointment of two shareholder representatives, board size reduction, and an Extraordinary General Meeting. He emphasizes the need for urgent action to rectify issues and warns against acquiring assets that could jeopardize financial stability.