Ultomiris (ravulizumab) is an AstraZeneca/Alexion program in primary IgA nephropathy at risk of disease progression (reduce proteinuria; accelerated approval). The FDA approved it on Oct 21, 2026. 1 FDA decision on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
FDA approval tracked on pdufa.bio: primary IgA nephropathy at risk of disease progression (reduce proteinuria; accelerated approval) (approved Oct 21, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: AstraZeneca/Alexion (AZN). Market-cap tier at the time we tracked it: Large. We track 1 catalyst event for this program: 0 upcoming and 1 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.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| OrbiMed Advisors | 915,700 | $171.1 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
No upcoming catalyst is on our calendar for Ultomiris (ravulizumab); 1 FDA decision is on record below.
On Oct 21, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records Ultomiris (ravulizumab) is FDA-approved for primary IgA nephropathy at risk of disease progression (reduce proteinuria; accelerated approval) (approved Oct 21, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
AstraZeneca/Alexion (AZN).
Yes. The FDA approved an application for Ultomiris (ravulizumab) on Oct 21, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.