Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
Imfinzi (durvalumab) was approved by the FDA on May 28, 2026 for Non-Muscle Invasive Bladder Cancer (NMIBC).
AstraZeneca PLC, Imfinzi (durvalumab) · Non-Muscle Invasive Bladder Cancer (NMIBC).
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (12/11/25) through T+5. Run-up high $209.48 on 2/19/26, low $179.64 on 12/17/25 (T-120 to T-1). FDA decision 5/28/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-05-28
OutcomeApproved
Drug / candidateImfinzi (durvalumab)
CompanyAstraZeneca PLC
120-day run-up (T-120→T-1)+2.2%
FDA record of the action: the FDA approved on May 28, 2026, per BLA 761069 SUPPL-53 (FDA letter). 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.
Specialist biotech funds holding AZN, 13F for the quarter ended June 30, 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.
Questions
Was Imfinzi (durvalumab) approved by the FDA?
Yes. The FDA approved the application for Imfinzi (durvalumab) on May 28, 2026, per the FDA's own record. The primary source is linked on this page.
Which company is behind Imfinzi (durvalumab)?
Imfinzi (durvalumab) is an AstraZeneca PLC (AZN) program. The FDA decision came on May 28, 2026; the FDA's own record of the decision is linked on this page.
How did AZN stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), AZN moved +2.2%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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