Ultomiris (ravulizumab) - IgA nephropathy was approved by the FDA on October 21, 2026 for IgA nephropathy (reduce proteinuria).
Verified against: FDA action day October 21, 2026 (BLA 761108 S-046) · Announcement October 21, 2026 (AstraZeneca 6-K) · Goal date none sourced.
Ultomiris was approved in the U.S. to reduce proteinuria in adults with primary IgA nephropathy at risk of disease progression, under accelerated approval based on proteinuria reduction in the ongoing Phase III I CAN trial.
Drugs@FDA records BLA 761108 supplement 46 (efficacy) for Ultomiris as approved on October 21, 2026 (Drugs@FDA). AstraZeneca announced it in a 6-K on October 22, 2026 (AstraZeneca 6-K): the indication is approved under accelerated approval based on reduction of proteinuria, and it has not been established whether Ultomiris slows kidney function decline. Continued approval may be contingent on the ongoing I CAN Phase III trial, whose primary endpoint is change in eGFR at week 106; the pre-specified interim analysis showed a 43.4% reduction in proteinuria versus placebo at 34 weeks. AstraZeneca stated no goal date for this application, so no early or late margin is published; this calendar had carried it as a December 2026 row with no source.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: Drugs@FDA, BLA 761108 S-046
FDA record of the action: the FDA approved on October 21, 2026, per BLA 761108 S-046 (Drugs@FDA). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| OrbiMed Advisors | 915,700 | $171.1 million | filed August 14, 2026 |
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Yes. The FDA approved the application for Ultomiris (ravulizumab) on October 21, 2026, per the FDA's own record. The primary source is linked on this page.
Ultomiris (ravulizumab) is an AstraZeneca (Alexion) (AZN) program. The FDA decision came on October 21, 2026; the FDA's own record of the decision is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), AZN moved -9.9%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.