Atacicept

DelveInsight's report highlights a robust lupus nephritis pipeline with 30+ companies developing 35+ therapies, including key players like AstraZeneca and Novartis. Promising therapies like Anifrolumab and Ianalumab are in various clinical phases, with recent updates from companies like Adicet Bio and Kyverna Therapeutics. The report provides comprehensive insights into the pipeline, therapeutic assessments, and market dynamics.

Vera Therapeutics granted Jason S. Carter, new Chief Legal Officer, inducement awards of 108,000 stock options and 53,000 restricted stock units, approved under the 2024 Inducement Plan, with vesting over four years. The stock option exercise price is $44.81, based on the November 18, 2024 closing price.

Vera Therapeutics appoints Jason S. Carter as Chief Legal Officer, enhancing its team for the pivotal ORIGIN 3 trial of atacicept in IgAN, with topline results expected in Q2 2025 and a planned BLA submission to the FDA.

IgA nephropathy affects 25-50 per million annually, with 20–40% progressing to end-stage kidney disease. Diagnosed cases in the US are expected to reach 135,000 by 2030. Treatments include ACE inhibitors, ARBs, corticosteroids, and immunosuppressants. FDA-approved treatments are TARPEYO, FILSPARI, and FABHALTA. The IgA nephropathy market is projected to reach ~USD 4.1 billion by 2034, driven by novel therapies like Novartis’ Atrasentan, Otsuka/Visterra’s Sibeprenlimab, Vertex/Alpine’s Povetacicept, and others.

Vera Therapeutics' Form 10-Q report reveals a net loss of $(46.6) million, up 132% YoY, with total operating expenses at $49.8 million. The company is advancing atacicept in Phase 3 ORIGIN 3 trial for IgAN, with topline results expected Q2 2025, and plans to initiate Phase 2 PIONEER trial in 2025 for non-IgAN autoimmune kidney diseases. Vera Therapeutics aims to expand atacicept's therapeutic indications and is preparing for regulatory submissions for IgAN in 2025. The company faces financial, regulatory, and competitive risks, necessitating ongoing capital management and strategic initiatives.

Atacicept, a dual BAFF/APRIL inhibitor, demonstrated sustained reductions in galactose-deficient IgA1, hematuria, and urine protein to creatinine ratio in a 96-week ORIGIN trial for IgA nephropathy, potentially slowing kidney decline to a rate similar to physiological aging.

Vera Therapeutics announces 96-week data from ORIGIN Phase 2b trial of atacicept in IgAN showing stabilized kidney function, published in the Journal of the American Society of Nephrology. Atacicept demonstrated reductions in Gd-IgA1, hematuria, and proteinuria, with a favorable safety profile. The company plans to announce Phase 3 ORIGIN 3 trial results in Q2 2025 and submit a BLA to the FDA.

Vera Therapeutics announced 96-week data from ORIGIN Phase 2b trial of atacicept in IgAN, showing stabilized kidney function, -66% Gd-IgA1 reduction, 75% hematuria resolution, -52% proteinuria reduction, and -0.6 mL/min/1.73m2/year eGFR slope, with 90% completion rate and favorable safety profile. Topline results from Phase 3 ORIGIN 3 trial expected Q2 2025, with planned BLA submission.

Vera Therapeutics (VERA) is a biotech company developing atacicept for autoimmune diseases like IgA nephropathy (IgAN) and lupus nephritis, showing promising results in Phase 2b ORIGIN trial. The company also advances MAU868 for BK virus infections in kidney transplant patients. Vera reported a net loss of $28.4 million for Q1 2024 but has sufficient cash reserves. The FDA granted Breakthrough Therapy Designation to atacicept for IgAN, expediting its development.