pdufa.bio
CalendarDecisionsReadoutsPatents
Drug IndexStocksScreenerConferencesAdvisory Committees
StudiesRun-up by YearLearnGlossaryMethodologyAPIAccount
Pro
Home › PDUFA Calendar › AZN

AZN PDUFA Date: Enhertu (trastuzumab deruxtecan)

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ Approved · the FDA decided this application on May 15, 2026. Decision page with the source and measured reaction.
FDA decision Approved May 15, 2026 · AstraZeneca PLC · HER2-positive early breast cancer
More Cancer & Oncology FDA decisions →All September 2026 PDUFA dates →

The story

Enhertu (trastuzumab deruxtecan) was approved by the FDA on May 15, 2026 to treat HER2-positive early breast cancer (Enhertu, trastuzumab deruxtecan).
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 decisionApproved May 15, 2026
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

What did the FDA decide on AZN's Enhertu (trastuzumab deruxtecan)?
The FDA decided AZN's (AstraZeneca PLC) application for Enhertu (trastuzumab deruxtecan) on May 15, 2026: Approved. pdufa.bio does not hold a sponsor-disclosed goal date for this application. Verify against the linked primary source.
What is AZN's drug Enhertu (trastuzumab deruxtecan)?
Enhertu (trastuzumab deruxtecan) is AstraZeneca PLC's drug, approved by the FDA on May 15, 2026 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.