Aurinia Pharmace Stock Price, News & Analysis

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.

Aurinia Pharmaceuticals reported strong Q2 2024 financial results, with total net revenue of $57.2 million, up 38% year-over-year. Net product revenue reached $55.0 million, a 34% increase. The company generated $15.8 million in free cash flow and had $330.7 million in cash and investments as of June 30, 2024. Aurinia narrowed its 2024 net product revenue guidance to $210-$220 million. The company also announced plans to advance AUR200, a potential next-generation therapy for autoimmune diseases. LUPKYNIS showed strong growth with 2,336 patients on therapy, a 22% increase from the previous year. Aurinia expects Japanese regulatory approval for LUPKYNIS in the second half of 2024.

Aurinia Pharmaceuticals (NASDAQ: AUPH) has announced it will release its second quarter 2024 financial and operational results on Thursday, August 1, 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 review the results and provide a general business update. Interested participants can join via phone or audio webcast, with a replay available on Aurinia's website afterwards.