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Zacks Investment Research <\/p>\nAstraZeneca\u00a0AZN announced that the FDA has accepted a regulatory filing seeking to expand the use of its blockbuster rare disease drug, Ultomiris (ravulizumab), for immunoglobulin A nephropathy (IgAN), a rare progressive kidney disease.<\/p>\n
The FDA has granted the filing priority review, shortening the review period by four months. A final decision is expected in the fourth quarter of 2026.<\/p>\n
If approved, Ultomiris will be the first C5 complement inhibitor available for IgAN.\u00a0The drug is currently approved in the United States, Europe and Japan across four indications. These include atypical haemolytic uraemic syndrome (aHUS), generalized myasthenia gravis (gMG), neuromyelitis optica spectrum disorder (NMOSD) and paroxysmal nocturnal haemoglobinuria (PNH).<\/p>\n
The FDA filing is supported by interim data from the late-stage I CAN study, which showed that treatment with the drug for 34 weeks led to a statistically significant and clinically meaningful reduction in proteinuria (protein in urine). Per AstraZeneca, Ultomiris demonstrated a 43.4% reduction in proteinuria compared to placebo.<\/p>\n
A potential approval would broaden the commercial potential of the drug, which is currently one of AstraZeneca\u2019s key growth drivers. In first-quarter 2026, Ultomiris generated $1.27 billion in sales, up 18% year over year, driven by strong demand across approved indications, geographic expansion and continued patient conversion from Soliris.<\/p>\n
AZN Stock Performance <\/p>\n
The stock underperformed the industry\u00a0in the year-to-date period, as seen in the chart below.<\/p>\n
Zacks Investment Research <\/p>\n
Image Source: Zacks Investment Research<\/p>\n
Other Players in the IgAN Space <\/p>\n
If approved, Ultomiris will likely compete with Calliditas Therapeutics\u2019 Tarpeyo, Novartis\u2019 NVS Fabhalta and Travere Therapeutics\u2019 TVTX Filspari.<\/p>\n
Both Calliditas\u2019 Tarpeyo and Travere\u2019s Filspari are approved for a similar indication \u2014 slowing the decline in kidney function in adults with primary IgAN who are at risk of disease progression.<\/p>\n
Novartis\u2019 Fabhalta is approved under the accelerated pathway for reducing proteinuria in adults with primary IgAN who are at risk of rapid disease progression. The NVS drug is also approved for complement 3 glomerulopathy (C3G) and PNH indications.<\/p>\n
AstraZeneca PLC Price AstraZeneca PLC Price <\/p>\n
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AstraZeneca PLC price | AstraZeneca PLC Quote<\/p>\n
AZN\u2019s Zacks Rank <\/p>\n
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see\u00a0the complete list of today\u2019s Zacks #1 Rank (Strong Buy) stocks here.<\/p>\n