Ultomiris (ravulizumab) is a AstraZeneca/Alexion program in IgA nephropathy (I CAN, sBLA). Its PDUFA date is Dec 2026, the FDA's goal date to complete review of the application. Every date links its source.
Indication under review: IgA nephropathy (I CAN, sBLA). Sponsor: AstraZeneca/Alexion (AZN). Market-cap tier at the time we tracked it: Large. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
When is Ultomiris (ravulizumab)'s next FDA decision or readout?
Ultomiris (ravulizumab)'s PDUFA date is Dec 2026. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
What happened at Ultomiris (ravulizumab)'s most recent FDA decision?
No FDA decision for Ultomiris (ravulizumab) is in our archive yet.
What is Ultomiris (ravulizumab) used for?
In our records Ultomiris (ravulizumab) is under review or in development for IgA nephropathy (I CAN, sBLA).
Who makes Ultomiris (ravulizumab)?
AstraZeneca/Alexion (AZN).
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
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