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. (AUPH) is a biopharmaceutical innovator developing therapies for autoimmune diseases with high unmet needs, including lupus nephritis. This page aggregates all company announcements, clinical trial updates, and regulatory developments.
Investors and healthcare professionals will find real-time access to earnings reports, partnership disclosures, and research milestones. Key coverage areas: FDA submissions, therapy commercialization progress, and scientific collaboration updates related to LUPKYNIS and pipeline candidates.
Bookmark this resource for verified information directly from corporate communications and curated third-party analysis. Check regularly for developments impacting Aurinia's position in autoimmune treatment markets.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) announced that the U.S. Patent Trial and Appeal Board (PTAB) has decided to institute an Inter Partes review of Patent No. 10,286,036, related to the dosing protocol of LUPKYNIS® for lupus nephritis. CEO Peter Greenleaf expressed disappointment but affirmed the Company's commitment to defend the patent. This patent provides protection until 2037. Aurinia also filed for a patent term extension for its existing composition patent, potentially extending its term to October 2027. A patentability determination is expected by July 26, 2023.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) will release its second-quarter 2022 financial and operational results on August 4, 2022, before market opening. A conference call and webcast will take place at 8:30 am ET to discuss these results and provide a business update. Interested parties can join through a toll-free number or via the company's website. Aurinia, headquartered in Victoria, British Columbia, is focused on therapies for serious diseases, notably its FDA-approved oral treatment, LUPKYNIS® (voclosporin), for lupus nephritis.
Aurinia Pharmaceuticals has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for its drug voclosporin (LUPKYNIS) to treat adults with active lupus nephritis. This recommendation is based on data from the Phase 3 AURORA 1 and AURORA 2 studies, which showed voclosporin was safe for up to three years. A decision from the European Commission is anticipated in two months. LUPKYNIS is already approved in the U.S. as the first oral treatment for this condition.
Aurinia Pharmaceuticals (NASDAQ: AUPH) announced the appointment of three key executives to strengthen its leadership team. Volker Knappertz, MD, will serve as Executive Vice President of Research and Development, enhancing the R&D function. Scott Habig takes on the role of Chief Commercial Officer to drive further success for LUPKYNIS®, the company’s first FDA-approved product. DeDe Sheel joins as Vice President of Investor Relations, focusing on improving investor engagement. Former CCO Max Colao is leaving Aurinia for personal reasons, marking a significant shift in the company's executive landscape.
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) announced the grant of inducement stock options and restricted stock units (RSUs) to 11 new employees. The stock options total 93,200 shares, with an exercise price of $11.38, vesting over three years. An additional 54,300 RSUs were also granted, vesting in three equal annual installments starting June 6, 2023. These grants adhere to Nasdaq Listing Rule 5635(c)(4) and aim to attract talent to support the company’s mission in treating autoimmune diseases.
Aurinia Pharmaceuticals (NASDAQ:AUPH) presented data at EULAR 2022 showing the efficacy of LUPKYNIS (voclosporin) in treating lupus nephritis (LN). The pooled analysis from the AURA-LV and AURORA 1 studies indicated that patients treated with voclosporin substantially met the European Alliance of Associations for Rheumatology's proteinuria treatment targets. At 12 months, 52.6% achieved UPCR ≤0.7 mg/mg compared to 33.1% in the control group. Dr. Anders noted this could lead to better long-term kidney health outcomes. LUPKYNIS was well tolerated with no unexpected safety signals.
Aurinia Pharmaceuticals presented significant findings on LUPKYNIS (voclosporin) at the 59th European Renal Association Congress in May 2022, demonstrating its long-term safety and efficacy for treating lupus nephritis (LN).
In the AURORA 2 study, LUPKYNIS showed a clinically relevant preservation of kidney function over three years, with no new safety signals. The study found comparable serious adverse event rates between voclosporin and control, indicating its well-tolerated profile. Additionally, early treatment responses were observed across various biopsy classes, reinforcing voclosporin's role in managing LN effectively.
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) has announced that data on LUPKYNIS™ (voclosporin) will be presented at the 59th European Renal Association (ERA) Congress and the European Congress of Rheumatology (EULAR) 2022. The events will showcase the results of the ongoing AURORA 2 continuation study, focusing on the long-term safety of LUPKYNIS for lupus nephritis. LUPKYNIS is notable as the first FDA-approved oral treatment for active lupus nephritis, with a dual mechanism of action aimed at stabilizing kidney function.
Aurinia Pharmaceuticals (NASDAQ: AUPH) reported net revenues of $21.6 million for Q1 2022, significantly up from $914,000 in Q1 2021, driven by strong demand for LUPKYNIS following its FDA approval in January 2021. The company maintains its revenue guidance of $115-$135 million for 2022, reflecting a growth of over 150-200% compared to 2021. Despite a net loss of $37.6 million for the quarter, improvements in patient start forms and an upcoming EMA review for LUPKYNIS are promising milestones. Aurinia's cash reserves stood at $418.8 million as of March 31, 2022.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) announced a change to the dial-in numbers for its first-quarter financial and operational results conference call on May 10, 2022. The updated numbers are (866) 682-6100 / (862) 298-0702 for U.S. and Canada participants. Additionally, an audio webcast will be accessible via the 'Investors' section on Aurinia's website, with a replay available following the event. Aurinia is known for its FDA-approved oral therapy for treating active lupus nephritis, focusing on serious diseases with high unmet medical needs.