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Home › PDUFA Calendar › JAZZ

JAZZ PDUFA Date: Ziihera (zanidatamab-hrii)

Updated ·next FDA decision on the calendar
FDA decision (PDUFA) target 2026-08-25 · Jazz Pharmaceuticals plc · First-line HER2-positive gastroesophageal adenocarcinoma (GEA)
More Cancer & Oncology FDA decisions →All August 2026 PDUFA dates →

The story

Ziihera (zanidatamab-hrii) is under FDA review to treat First-line HER2-positive gastroesophageal adenocarcinoma (GEA).
Full PDUFA calendar ->Every upcoming FDA decision date, by monthLNTH-lnth-2501 . 2026-06-29Same area: Oncology . LNTH-2501 (Gallium-68 edotreotide)AZN-truqap . 2026-06-30Same area: Oncology . TruqapMRNA . 2026-08-05Same month decision . mRNA-1010
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

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

$240.06$168.72
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-08-25
Drug / candidateZiihera (zanidatamab-hrii)
IndicationFirst-line HER2-positive gastroesophageal adenocarcinoma (GEA)
CompanyJazz Pharmaceuticals plc
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT05152147 · active

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 JAZZ PDUFA date?
The FDA PDUFA target date for JAZZ (Jazz Pharmaceuticals plc) is 2026-08-25 for Ziihera (zanidatamab-hrii). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is JAZZ's drug Ziihera (zanidatamab-hrii)?
Ziihera (zanidatamab-hrii) is Jazz Pharmaceuticals plc's candidate under FDA review for First-line HER2-positive gastroesophageal adenocarcinoma (GEA).
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.