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Home › PDUFA Calendar › AZN

AZN PDUFA Date: Enhertu (trastuzumab deruxtecan)

Updated ·next FDA decision on the calendar
FDA decision (PDUFA) target 2026-09-30 · AstraZeneca PLC · HER2-positive early breast cancer
More Cancer & Oncology FDA decisions →All September 2026 PDUFA dates →

The story

Enhertu (trastuzumab deruxtecan) is under FDA review to treat advanced breast and other PTEN-altered cancers (the AKT-inhibitor Truqap/capivasertib).
Full PDUFA calendar ->Every upcoming FDA decision date, by monthLNTH-lnth-2501 . 2026-06-29Same area: Oncology . LNTH-2501 (Gallium-68 edotreotide)CELC . 2026-07-17Same area: Oncology . Gedatolisib with FulvestrantTLX . 2026-09-11Same month decision . TLX101-Px
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

AZN run-up into the PDUFA (last ~120 days)

$208.67$176.28
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-09-30
Drug / candidateEnhertu (trastuzumab deruxtecan)
IndicationHER2-positive early breast cancer
CompanyAstraZeneca PLC
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNot listed

New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs.

See the full 2026 PDUFA calendar →

FAQ

When is the AZN PDUFA date?
The FDA PDUFA target date for AZN (AstraZeneca PLC) is 2026-09-30 for Enhertu (trastuzumab deruxtecan). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is AZN's drug Enhertu (trastuzumab deruxtecan)?
Enhertu (trastuzumab deruxtecan) is AstraZeneca PLC's candidate under FDA review for HER2-positive early breast cancer.
What typically happens to a large-cap stock into a PDUFA date?
Historically, large-cap names had a median decision-day move around ±1% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · large-cap cohortn=790 · median +0.0% · 50% up
under -30%: 2 of 790 (0%)<-30-30 to -15%: 2 of 790 (0%)-15 to -7%: 6 of 790 (1%)-7 to -3%: 29 of 790 (4%)-3 to +3%: 707 of 790 (89%)±3+3 to +7%: 35 of 790 (4%)+7 to +15%: 5 of 790 (1%)+15 to +30%: 2 of 790 (0%)over +30%: 2 of 790 (0%)>+30
Distribution of next-day % moves after the FDA decision for large-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.