AUR200 / Vitesse Biologics, Aurinia Pharma - LARVOL DELTA

Aurinia Pharmaceuticals Reports Financial Results for the Three and Twelve Months Ended December 31, 2024 and Provides Update on Recent Corporate Progress (Businesswire) - "For the three months ended December 31, 2024, net product sales of LUPKYNIS, the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis, were $57.6 million, up 36% from $42.3 million in the same period of 2023...For the twelve months ended December 31, 2024, net product sales were $216.2 million, up 36% from $158.5 million in 2023...Aurinia expects to report initial results from its Phase 1 study of AUR200 in the second quarter of 2025."

New P1 trial • Sales • Immunology • Lupus Nephritis

Aurinia Announces First Participant Dosed in AUR200 Single Ascending Dose Trial (Businesswire) - "Aurinia Pharmaceuticals...announced today that the first participant has been dosed in a Phase 1a single ascending dose (SAD) study of 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). The SAD study will assess the safety, tolerability, pharmacokinetics, and changes in biomarkers for AUR200 in healthy volunteers, with data expected in the first half of 2025."

P1 data • Trial status • Lupus

Aurinia Pharmaceuticals Reports Second Quarter and Six Months 2024 Financial and Operational Results (Businesswire) - "The Company anticipates Japanese regulatory authorities' approval of LUPKYNIS in the second half of this year, based on the JNDA that Otsuka filed in November 2023 for approval of LUPKYNIS to treat adults with LN. Upon approval, the Company expects to receive a milestone payment of $10 million with low double-digit royalties on net sales once launched....Achieved 22% growth in patients on LUPKYNIS therapy, with approximately 2,336 patients on therapy as of June 30, 2024, compared to 1,911 as of June 30, 2023....Additionally, the Company is moving forward with development of its pipeline asset AUR200...First patients are expected to enter the Phase 1 Single Ascending Dose (SAD) study of AUR200 in the third quarter of 2024. Data from the SAD study, including safety, tolerability, pharmacokinetics, and biomarkers, is anticipated in the first half of 2025."

Commercial • Japan approval • New P1 trial • P1 data • Immunology • Lupus Nephritis

AUR200: An Improved BAFF/APRIL Inhibitor with Increased Potency and Safety for the Treatment of B Cell-Mediated Diseases (ACR Convergence 2022) - "AUR200 is a BCMA-IgG4 Fc fusion protein currently in preclinical development. AUR200 demonstrates best in class binding affinity to both BAFF and APRIL due to the engineered modifications to the BCMA binding pocket. In a mouse model of SLE, AUR200 dosed therapeutically reduced several markers of disease activity and improved overall survival."

Clinical • IO biomarker • Immune Modulation • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Renal Disease • Systemic Lupus Erythematosus • IFNG • IL17A