We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
FDA Accepts AstraZeneca's Filing for Expanded Use of Ultomiris
Read MoreHide Full Article
Key Takeaways
AstraZeneca's filing to expand Ultomiris use in IgAN received FDA priority review.
Ultomiris cut proteinuria by 43.4% versus placebo in the late-stage I CAN study.
AZN reported $1.27 billion in Q1 2026 Ultomiris sales, up 18% year over year.
AstraZeneca (AZN - Free Report) 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.
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.
If approved, Ultomiris will be the first C5 complement inhibitor available for IgAN. The 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).
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.
A potential approval would broaden the commercial potential of the drug, which is currently one of AstraZeneca’s 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.
AZN Stock Performance
The stock underperformed the industry in the year-to-date period, as seen in the chart below.
Image Source: Zacks Investment Research
Other Players in the IgAN Space
If approved, Ultomiris will likely compete with Calliditas Therapeutics’ Tarpeyo, Novartis’ (NVS - Free Report) Fabhalta and Travere Therapeutics’ (TVTX - Free Report) Filspari.
Both Calliditas’ Tarpeyo and Travere’s Filspari are approved for a similar indication — slowing the decline in kidney function in adults with primary IgAN who are at risk of disease progression.
Novartis’ 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.
View the Zacks #1 Rank List
Image: Bigstock
FDA Accepts AstraZeneca's Filing for Expanded Use of Ultomiris
Key Takeaways
AstraZeneca (AZN - Free Report) 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.
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.
If approved, Ultomiris will be the first C5 complement inhibitor available for IgAN. The 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).
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.
A potential approval would broaden the commercial potential of the drug, which is currently one of AstraZeneca’s 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.
AZN Stock Performance
The stock underperformed the industry in the year-to-date period, as seen in the chart below.
Image Source: Zacks Investment Research
Other Players in the IgAN Space
If approved, Ultomiris will likely compete with Calliditas Therapeutics’ Tarpeyo, Novartis’ (NVS - Free Report) Fabhalta and Travere Therapeutics’ (TVTX - Free Report) Filspari.
Both Calliditas’ Tarpeyo and Travere’s Filspari are approved for a similar indication — slowing the decline in kidney function in adults with primary IgAN who are at risk of disease progression.
Novartis’ 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.
AstraZeneca PLC Price
AstraZeneca PLC price | AstraZeneca PLC Quote
AZN’s Zacks Rank
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.