Atrasentan

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.

Goodwin's two-part series on Greater China's life sciences sector highlights stable M&A activity in pharmaceuticals/biotech despite market fluctuations. Notable 2024 deals include Fosun's $1.71B acquisition of Shanghai Henlius Biotech, Johnson & Johnson's $850M purchase of Proteologix, and Novartis' acquisition of SanReno Therapeutics. Trends indicate a shift towards CAR-T cell therapies and large molecule/biologics, with medical devices also gaining significance. Factors driving recovery include regulatory changes, market readjustments, and the maturing of early-stage investments.

Goodwin's two-part series on Greater China's life sciences sector highlights stable M&A activity in pharmaceutical/biotech despite market fluctuations. Notable 2024 deals include Fosun Pharma's $1.71B acquisition of Shanghai Henlius Biotech and Johnson & Johnson's $850M acquisition of Proteologix, Inc. Trends indicate a shift towards CAR-T cell therapies and large molecule/biologics, with medical devices also playing a significant role. Factors driving recovery include regulatory changes, market readjustments, and the maturing of early-stage investments.

Atrasentan significantly reduced proteinuria by 36.1 percentage points in high-risk IgA nephropathy patients after 36 weeks, with a favorable safety profile compared to placebo, according to interim Phase III ALIGN trial data published in The New England Journal of Medicine.

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.

Atrasentan significantly reduced proteinuria in IgA nephropathy patients, showing a 36.1 percentage point greater reduction in urinary protein-to-creatinine ratio (UPCR) compared to placebo in the ALIGN study. The drug demonstrated a 38.1% reduction in UPCR over 36 weeks, with significant reduction by week 6. The study's final results will confirm if this reduction translates to preserved kidney function.

Novartis' oral Fabhalta® (iptacopan) sustained clinically meaningful results at one year in Phase III C3 glomerulopathy (C3G) trial, showing sustained proteinuria reduction and improved eGFR slope, with a favorable safety profile. Fabhalta is the only oral alternative complement pathway inhibitor targeting C3G's underlying cause, with regulatory submissions completed in the EU, China, and Japan, and expected in the US by year-end.

Otsuka's anti-APRIL antibody sibeprenlimab showed significant reduction in uPCR in a phase 3 trial for IgA nephropathy, prompting potential FDA submission. Final results expected in 2026. Competitors include Novartis' zigakibart, Vertex's povetacicept, and Vera's atacicept.

AbbVie and Novartis are recommended as 'forever' dividend stocks, with AbbVie overcoming Humira's patent loss and Novartis focusing on innovative medicines post-spinoff, both offering strong dividend yields.

Purespring Therapeutics secures £80m ($105m) to advance its AAV gene therapy PS-002 for IgA nephropathy (IgAN) into Phase I/II trials. The therapy targets podocytes, crucial for kidney function, aiming to address inflammation and prevent end-stage renal disease. The funding round was led by Sofinnova Partners and includes Gilde Healthcare, Forbion, British Patient Capital, and Syncona. Purespring's platform, FunSel, selects effective treatments from a library of AAV vectors, independent of specific genes or mechanisms.