Iptacopan

Novartis to present over 65 abstracts at ASH and SABCS, including 96-week Scemblix Phase III ASC4FIRST results and Kisqali 4-year NATALEE trial analysis. The presentations highlight advancements in hematologic diseases and cancers, emphasizing earlier disease stages and new treatment options.

C3G is a rare, progressive kidney disease with limited long-term treatments; Spherix studies reveal nephrologists' interest in new therapies targeting complement system pathways. Novartis' Fabhalta and Apellis' Empaveli show promise in Phase III trials, with significant reductions in proteinuria. Spherix continues to track market developments and patient treatment patterns.

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.

Novartis presented 12-month APPEAR-C3G study data at ASN Kidney Week 2024 showing Fabhalta (iptacopan) sustained clinically meaningful proteinuria reduction and eGFR improvement in C3G patients, with a favorable safety profile. Fabhalta, an oral complement inhibitor, could be the first FDA-approved treatment for C3G, with regulatory submissions completed in the EU, China, and Japan, and expected in the US by year-end.

Novartis Q3 2024 results: net sales +10% (cc, +9% USD), core operating income +20% (cc, +17% USD), driven by strong performance from Entresto, Cosentyx, Kisqali, Kesimpta, Pluvicto, and Leqvio. Operating income +123% (cc, +106% USD), net income +121% (cc, +111% USD), core EPS +20% (cc, +18% USD) to USD 2.06. Free cash flow USD 6.0 billion (+18% USD). Full-year 2024 guidance raised: net sales expected to grow low double-digit, core operating income high teens.

Novartis reports sustained, clinically meaningful results of Fabhalta in C3G, showing reduction in proteinuria and improvement in eGFR slope. Regulatory submissions for Fabhalta in C3G are completed in the EU, China, and Japan, with a US submission expected by year-end.

Novartis' Fabhalta (iptacopan) showed sustained benefits for C3 glomerulopathy (C3G) patients in Phase III APPEAR-C3G study, reducing proteinuria and improving kidney function over 12 months. The treatment's safety profile remained favourable, with regulatory submissions completed in the EU, China, and Japan, and expected in the US by year-end.

Novartis presented 12-month Phase III APPEAR-C3G study data at ASN Kidney Week 2024, showing oral Fabhalta plus supportive care led to sustained, clinically meaningful proteinuria reduction in C3 glomerulopathy patients, with improvements in estimated glomerular filtration rate slope and a favorable safety profile.