Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
Datopotamab Deruxtecan (Dato-DXd) was approved by the FDA on May 22, 2026 for metastatic triple negative breast cancer (TNBC).
AstraZeneca PLC, Datopotamab Deruxtecan (Dato-DXd) · Metastatic triple negative breast cancer (TNBC).
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (12/5/25) through T+5. Run-up high $209.48 on 2/18/26, low $179.64 on 12/16/25 (T-120 to T-1). FDA decision 5/22/26. Historical price action, not a forecast.
Drug / candidateDatopotamab Deruxtecan (Dato-DXd) - (TROPION
CompanyAstraZeneca PLC
120-day run-up (T-120→T-1)+2.3%
FDA record of the action: the FDA approved on May 22, 2026, per BLA 761394 SUPPL-3 (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 Datopotamab Deruxtecan (Dato-DXd) approved by the FDA?
Yes. The FDA approved the application for Datopotamab Deruxtecan (Dato-DXd) on May 22, 2026, per the FDA's own record. The primary source is linked on this page.
Which company is behind Datopotamab Deruxtecan (Dato-DXd)?
Datopotamab Deruxtecan (Dato-DXd) is an AstraZeneca PLC (AZN) program. The FDA decision came on May 22, 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 +2.3%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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