FDA approves Novartis drug Fabhalta for rare kidney disease treatment, leading to stock rise.

From Zacks Investment Research: 2025-03-21 15:14:00

The FDA approved Novartis drug Fabhalta for the treatment of progressive and ultra-rare kidney disease. Novartis shares rose 20.3% in the past year, outperforming the industry decline of 2%. The company reported better-than-expected fourth-quarter 2024 results with both earnings and revenues beating estimates. Fabhalta is the first and only treatment approved for C3 glomerulopathy, a rare kidney disease usually diagnosed in young adults. The drug also received approval for paroxysmal nocturnal hemoglobinuria and primary IgA nephropathy. Novartis is evaluating Fabhalta for other rare kidney diseases and is focused on strengthening its pipeline with acquisitions.

In the APPEAR-C3G study, Fabhalta showed clinically meaningful reduction in proteinuria for patients with C3G. Novartis expects a final decision from the European Commission on Fabhalta’s C3G indication in two months. The company also has two additional IgAN therapies in late-stage development. Novartis reported strong quarterly performance with net sales expected to grow in mid to high single digits and core operating income in high single to low double digits for 2025. Novartis recently announced the acquisition of Anthos Therapeutics, Inc. for $925 million upfront with potential additional payments of up to $2.15 billion.

Novartis currently holds a Zacks Rank #3 (Hold). Better-ranked stocks in the pharma/biotech sector include Bayer and Gilead Sciences, both carrying a Zacks Rank #2 (Buy). Bayer’s EPS estimate for 2025 and 2026 has increased in the past 30 days with shares rising 33.8% in the past three months. Gilead Sciences’ EPS estimate for 2025 and 2026 has also increased in the past 30 days with earnings beating estimates in the trailing four quarters.



Read more at Zacks Investment Research: FDA Approves Novartis Drug for Rare Kidney Disease Treatment – March 21, 2025