Aurinia Pharmace Stock Price, News & Analysis

Aurinia Pharmaceuticals announced that the European Commission has granted marketing authorization for LUPKYNIS (voclosporin) to treat adults with active lupus nephritis, marking it as the first oral treatment approved in both the U.S. and Europe. This approval will trigger a $30 million milestone payment, expected to be recognized as revenue in Q3. The decision is based on positive results from pivotal Phase 3 studies. LUPKYNIS is also under review in Great Britain and Switzerland, with further milestone payments linked to its success.

Aurinia Pharmaceuticals reported a net revenue of $28.2 million for Q2 2022, significantly up from $6.6 million in Q2 2021. The company maintains its 2022 revenue guidance of $115-$135 million, mainly from its drug, LUPKYNIS® (voclosporin). The patient treatment count has risen to 1,274, with strong conversion rates and payor coverage. However, the net loss for the quarter was $35.5 million, an improvement from a $47 million loss in the prior year. Aurinia also reported $391.7 million in cash and investments as of June 30, 2022, ensuring adequate liquidity for upcoming operations.

Aurinia Pharmaceuticals (NASDAQ:AUPH) announced the grant of inducement stock options and restricted stock units (RSUs) to new executives and employees. The Compensation Committee approved 488,095 stock options and 290,343 RSUs for new executives Volker Knappertz and Scott Habig, alongside 123,100 stock options and 73,700 RSUs for ten new employees. The options have an exercise price of $8.18, the stock's closing price on July 29, 2022, and vest over three years. This aligns with Nasdaq Listing Rule 5635(c)(4) for inducement grants.

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.