Latest news with #lupusnephritis
National Post
2 days ago
- Business
- National Post
Aurinia Pharmaceuticals to Host Conference Call to Discuss AUR200 Phase 1 Study Results on June 30, 2025
Article content ROCKVILLE, Md. & EDMONTON, Alberta — Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today announced that it will host a webcast and conference call on June 30, 2025, at 8:30 a.m. ET to discuss AUR200 Phase 1 study results. The link to the webcast is available here. To join the conference call, please dial 877-407-9170/+1 201-493-6756. Click here for participant International Toll-Free access numbers. A replay of the webcast will be available on Aurinia's website. Article content About Aurinia Article content Article content Aurinia is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS ® (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis. Aurinia is also developing AUR200, a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL) for the potential treatment of autoimmune diseases. Article content Article content Article content Article content Article content Article content
Yahoo
3 days ago
- Business
- Yahoo
Aurinia (AUPH) Surges 7.5%: Is This an Indication of Further Gains?
Aurinia Pharmaceuticals (AUPH) shares ended the last trading session 7.5% higher at $8.63. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 0.6% gain over the past four weeks. The sudden price rise can be attributable to positive investor expectations for Lupkynis, the company's sole marketed drug, which is approved for the treatment of adults with active lupus nephritis (LN). Lupkynis sales increased 25% year over year to $60 million during the first quarter of 2025. This biotechnology company is expected to post quarterly earnings of $0.18 per share in its upcoming report, which represents a year-over-year change of +800%. Revenues are expected to be $64.23 million, up 12.3% from the year-ago quarter. Earnings and revenue growth expectations certainly give a good sense of the potential strength in a stock, but empirical research shows that trends in earnings estimate revisions are strongly correlated with near-term stock price movements. For Aurinia, the consensus EPS estimate for the quarter has remained unchanged over the last 30 days. And a stock's price usually doesn't keep moving higher in the absence of any trend in earnings estimate revisions. So, make sure to keep an eye on AUPH going forward to see if this recent jump can turn into more strength down the road. The stock currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>> Aurinia is a member of the Zacks Medical - Drugs industry. One other stock in the same industry, Corcept Therapeutics (CORT), finished the last trading session 0.5% higher at $74.33. CORT has returned -4.7% over the past month. Corcept's consensus EPS estimate for the upcoming report has remained unchanged over the past month at $0.23. Compared to the company's year-ago EPS, this represents a change of -28.1%. Corcept currently boasts a Zacks Rank of #3 (Hold). Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Aurinia Pharmaceuticals Inc (AUPH) : Free Stock Analysis Report Corcept Therapeutics Incorporated (CORT) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
3 days ago
- Business
- Yahoo
GSK (GSK) Gains FDA Approval for Benlysta Autoinjector for Lupus Treatment
GSK plc (NYSE:GSK) is one of the 11 best European stocks to invest in. On June 24, the company announced receipt of FDA approval for a 200 mg/mL autoinjector of Benlysta (belimumab) for the treatment of active lupus nephritis (LN). The approval applies to children aged five years and above. A pharmacist looking at a prescription bottle of gastrointestinal drugs. Benlysta autoinjector is the first-of-its-kind treatment option for at-home administration. The drug is a B-lymphocyte stimulator (BLyS)-specific inhibiting monoclonal antibody. It works by binding to soluble BLyS, which inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. It does not bind B cells directly. The 200 mg/mL autoinjector was previously approved for pediatric patients with active systemic lupus erythematosus (SLE) in 2024. Benlysta was the first and only approved biologic for both SLE and lupus nephritis in over 50 years, including for the pediatric population. The autoinjector will be available for patients and their caregivers immediately. GSK plc (NYSE:GSK) is a UK-based global biopharmaceutical company. It researches, develops, and sells medicines and vaccines for infectious diseases, HIV, respiratory conditions, cancer, and immune-related disorders. Its key products include Shingrix (shingles vaccine), Nucala (asthma), and HIV treatments through its ViiV Healthcare joint venture. While we acknowledge the potential of GSK as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: and . Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
National Post
22-05-2025
- Health
- National Post
New AURORA 1 Analysis: LUPKYNIS-Based Triple Immunosuppressive Therapy Yields Deep Proteinuria Reduction in Lupus Nephritis
Article content ROCKVILLE, Md. & EDMONTON, Alberta — Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company), today announced that a post-hoc analysis of the 52-week, Phase 3 AURORA 1 study showed that lupus nephritis (LN) patients who received triple immunosuppressive therapy with LUPKYNIS ® (voclosporin), mycophenolate mofetil (MMF), and low-dose glucocorticoids achieved lower proteinuria targets at substantially higher rates compared to patients in the control group who received mycophenolate mofetil (MMF) and low-dose glucocorticoids alone. Article content The analysis assessed the achievement of urine protein creatine ratio (UPCR) targets of ≤0.4 g/g, ≤0.3 g/g, ≤0.2 g/g (classified as ultra-low UPCR), and ≤0.1 g/g in LN patients treated with LUPKYNIS-based triple immunosuppressive therapy compared to patients in the control group. Of the 357 patients in AURORA 1, 60.9% in the triple immunosuppressive therapy group (N=109) achieved a UPCR of ≤0.4 g/g at least once during the study compared to 37.1% of patients in the control group (N=66). Patients in the triple immunosuppressive therapy group also achieved higher rates of all other UPCR targets compared to patients in the control group. Adverse event rates were comparable in both groups. Article content 'It is widely known that no level of proteinuria is safe for nephrons and that early reductions in proteinuria are predictive of better long-term kidney outcomes. Yet, UPCR endpoints have varied widely across clinical trials and in clinical practice,' said lead study author Maria Dall'Era, M.D., Professor of Medicine in the Division of Rheumatology, University of California, San Francisco. 'This analysis shows that achieving UPCR targets of ≤0.4 g/g may be a feasible goal and that a voclosporin-based triple immunosuppressive therapy regimen can reduce proteinuria to profoundly low levels in a proportion of patients.' Article content An additional post-hoc analysis from the AURORA 1 study evaluated lipidomic profiles in LN patients based on achievement of proteinuria reductions, including ultra-low UPCR, at Week 52. The analysis found a distinct lipidomic profile in patients who achieved ultra-low UPCR. This analysis builds upon a previous analysis of AURORA 1 in which patients who received triple immunosuppressive therapy with LUPKYNIS achieved significantly greater improvements in total and low-density lipoprotein (LDL) cholesterol compared to those in the control group. While further research is needed to clarify the role of certain lipids in the biochemistry of LN patients, these preliminary findings suggest that attaining ultra-low UPCR targets may provide additional benefits to LN patients and contribute to modification of cardiovascular disease risk. Article content An analysis of real-world baseline data from ENLIGHT-LN, a U.S.-based prospective, observational registry of adult LN patients treated with LUPKYNIS, was also presented at LUPUS 2025. 'The data presented at LUPUS 2025 highlight the critical role of LUPKYNIS in improving health outcomes for LN patients. Early reduction of proteinuria to the lowest possible levels and long-term preservation of kidney health are key goals of LN therapy. These data provide compelling evidence that LUPKYNIS-based therapy can achieve significantly lower UPCR targets, potentially reducing the risk of significant kidney damage and other comorbidities,' said Dr. Greg Keenan, Chief Medical Officer of Aurinia. Article content Title: Attainment of Ultra-Low Levels of UPCR in the AURORA 1 Study Associated with Alterations in the Circulating Lipidome Authors: Farsad Afshinnia, Subramaniam Pennathur, Michelle Zubrycki, Linda Rehaume, Lucy Hodge Date: Thursday, May 22 Time: 12:10 – 1:10 PM ET Abstract Number: 252 Article content About LUPKYNIS Article content LUPKYNIS is a second generation calcineurin inhibitor with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The AURORA Clinical Program, comprised of the AURORA 1 pivotal trial and AURORA 2 extension trial, demonstrated the importance of triple immunosuppressive therapy with LUPKYNIS, mycophenolate mofetil, and low-dose glucocorticoids to preserve kidney health in lupus nephritis patients without reliance on chronic high-dose glucocorticoids. It is the only clinical program in lupus nephritis to include three years of triple immunosuppressive therapy. Article content About Aurinia Article content Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS ® (voclosporin), the first FDA-approved oral therapy dedicated to the treatment of adult patients with active lupus nephritis. Aurinia is also developing AUR200, a differentiated, potential best-in-class therapy for autoimmune diseases that targets both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand). Article content LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN). Article content Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation. Article content CONTRAINDICATIONS: LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients. Article content WARNINGS AND PRECAUTIONS Article content Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent. Article content Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections. These infections may lead to serious, including fatal, outcomes. Article content Nephrotoxicity: LUPKYNIS, like other calcineurin inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity. Monitor eGFR regularly. Article content Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy. Monitor blood pressure regularly. Article content Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions. Monitor for neurologic symptoms. Article content Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with CNIs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia. Monitor serum potassium levels periodically. Article content QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation. Article content Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS. Article content Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS. Article content Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Co-administration of LUPKYNIS with strong CYP3A4 inhibitors is contraindicated. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Avoid use of LUPKYNIS with strong or moderate CYP3A4 inducers. Article content ADVERSE REACTIONS Article content The most common adverse reactions (≥3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite. Article content SPECIFIC POPULATIONS Article content Pregnancy: Avoid use of LUPKYNIS. Article content Lactation: Consider the mother's clinical need for LUPKYNIS and any potential adverse effects to the breastfed infant when prescribing LUPKYNIS to a lactating woman. Article content Renal Impairment: LUPKYNIS is not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m 2 unless benefit exceeds risk. If used in this population, reduce LUPKYNIS dose. Article content Dall'Era M. et al. Achievement of Proteinuria Less Than 0.4 G/G in the Phase 3 AURORA 1 Study of Voclosporin in Lupus Nephritis. Presented at LUPUS 2025 Congress, 2025, Toronto, CA. Geraldino-Pardilla L. et al. Baseline Demographics, Clinical Characteristics, and Treatment Regimens of an Initial Cohort of Patients Receiving Voclosporin for Lupus Nephritis in the Enlight-LN Registry. Presented at LUPUS 2025 Congress, 2025, Toronto, CA. Afshinnia F. et al. Attainment of Ultra-Low Levels of UPCR in the AURORA 1 Study Associated with Alterations in the Circulating Lipidome. Presented at LUPUS 2025 Congress, 2025, Toronto, CA. Arriens C. et al. Arthritis Care & Research. Vol. 75, No. 7, July 2023, pp 1399–1408. Article content Article content Article content Article content Article content Contacts Article content Article content
