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Home › PDUFA Calendar › ZYME

ZYME PDUFA Date: Ziihera (zanidatamab-hrii)

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 August 25, 2026 on its goal date. Decision page with the source and measured reaction.
FDA decision Approved August 25, 2026 · Zymeworks Inc. · First-line HER2-positive gastroesophageal adenocarcinoma (GEA)
More Cancer & Oncology FDA decisions →All August 2026 PDUFA dates →

The story

Ziihera (zanidatamab-hrii) was approved by the FDA on August 25, 2026 to treat First-line HER2-positive gastroesophageal adenocarcinoma (GEA). Balance sheet: about 58 months of cash, runway into 2H 2027 (company-guided).
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.

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

$28.56$22.49
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA decisionApproved August 25, 2026
FDA goal date2026-08-25
Drug / candidateZiihera (zanidatamab-hrii)
IndicationFirst-line HER2-positive gastroesophageal adenocarcinoma (GEA)
CompanyZymeworks Inc.
Market-cap tierSmall
Cohort decision-day move (history)±3% median
ClinicalTrials.govNCT05152147 · active

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See the full 2026 PDUFA calendar →

FAQ

What did the FDA decide on ZYME's Ziihera (zanidatamab-hrii)?
The FDA decided ZYME's (Zymeworks Inc.) application for Ziihera (zanidatamab-hrii) on August 25, 2026: Approved. The FDA goal date for this application was 2026-08-25. Verify against the linked primary source.
What is ZYME's drug Ziihera (zanidatamab-hrii)?
Ziihera (zanidatamab-hrii) is Zymeworks Inc.'s drug, approved by the FDA on August 25, 2026 for First-line HER2-positive gastroesophageal adenocarcinoma (GEA).
What typically happens to a small-cap stock into a PDUFA date?
Historically, small-cap names had a median decision-day move around ±3% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · small-cap cohortn=274 · median +0.0% · 49% up
under -30%: 5 of 274 (2%)<-30-30 to -15%: 10 of 274 (4%)-15 to -7%: 25 of 274 (9%)-7 to -3%: 36 of 274 (13%)-3 to +3%: 131 of 274 (48%)±3+3 to +7%: 30 of 274 (11%)+7 to +15%: 21 of 274 (8%)+15 to +30%: 10 of 274 (4%)over +30%: 6 of 274 (2%)>+30
Distribution of next-day % moves after the FDA decision for small-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.