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ROCKVILLE, Md. & EDMONTON, Alberta - Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) reported positive results from its Phase 1 single-ascending-dose study of aritinercept, a dual inhibitor of B cell-activating factor and a proliferation-inducing ligand, according to a company press release.
The study evaluated six different doses of aritinercept administered by subcutaneous injection in 61 healthy subjects. Results showed the drug was well tolerated across all dose levels with no treatment-related serious adverse events or discontinuations due to treatment-related issues.
The most common adverse events included injection site reactions (24% for aritinercept vs. 13% for placebo), headache (11% vs. 7%), upper respiratory tract infection (7% vs. 0%), and back pain (4% vs. 0%). All injection site reactions were classified as Grade 1.
Single doses of aritinercept demonstrated significant reductions in immunoglobulins, with mean decreases from baseline to Day 28 of up to 48% for immunoglobulin A, 55% for immunoglobulin M, and 20% for immunoglobulin G.
"Based on today’s positive results, which indicate robust and long-lasting pharmacodynamic effects supportive of once-monthly dosing, we plan to initiate clinical studies of aritinercept in at least two autoimmune diseases in the second half of this year," said Dr. Greg Keenan, Chief Medical Officer of Aurinia, in the press release. The company’s strong financial position, with more cash than debt on its balance sheet and a current ratio of 5.93, provides solid backing for these expansion plans. InvestingPro analysis suggests the stock is currently undervalued, with 10 additional exclusive insights available to subscribers.
Aurinia, which introduced LUPKYNIS for lupus nephritis in January 2021, is developing aritinercept as a potential treatment for various autoimmune diseases where B cells produce disease-causing autoantibodies. The company has demonstrated strong commercial execution, with revenue growing 29.2% in the last twelve months to $247.3 million. Detailed analysis of Aurinia’s growth potential and comprehensive financial metrics are available in the InvestingPro Research Report, part of the platform’s coverage of over 1,400 US equities.
In other recent news, Aurinia Pharmaceuticals reported first-quarter net product sales of $60.0 million for their drug Lupkynis, slightly exceeding estimates from Leerink Partners and the consensus. The company has maintained its yearly guidance for 2025, projecting total net product sales between $240-250 million, reflecting a 13% year-over-year increase at the midpoint. Leerink Partners reiterated their Outperform rating on Aurinia, with a steady price target of $10.00, highlighting the promising 4% quarterly growth in Lupkynis sales despite typical early-year challenges. The firm projects sales of $245.2 million for the year, aligning closely with the consensus estimate of $246.3 million.
Aurinia’s financial position remains strong, ending the first quarter with a net income of $23.3 million and $312.9 million in cash, cash equivalents, restricted cash, and investments. The company also repurchased 5.8 million shares for $47.4 million during the quarter. Additionally, Aurinia is anticipating Phase 1 single ascending dose data for AUR200, a treatment designed to inhibit APRIL and BAFF, later this quarter. Leerink noted the recent update to the American College of Rheumatology’s lupus nephritis treatment guidelines, which may benefit Aurinia as they focus on educating rheumatologists about Lupkynis. The firm’s financial model for Aurinia is currently under review, but their positive outlook remains unchanged.
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