PDUFA date for Ziihera (zanidatamab) in first-line HER2+ GEA
The FDA’s decision on Jazz’s Ziihera (zanidatamab-hrii) for First-line HER2-positive locally advanced/metastatic gastroesophageal adenocarcinoma (combinations) was due on Aug 25, 2026. The outcome isn’t recorded here yet — the linked source has the latest.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Jazz Pharmaceuticals plc JAZZ
- Drug
- Ziihera (zanidatamab-hrii)
- For
- First-line HER2-positive locally advanced/metastatic gastroesophageal adenocarcinoma (combinations)
- Stage
- sBLA under priority review
- When
- Aug 25, 2026
- Source note
- Jazz PR: FDA accepted the sBLA with priority review and set a PDUFA target action date of August 25, 2026, based on Phase 3 HERIZON-GEA-01. Company prepared for immediate launch on approval.
- Checked
- Checked by a person when it was added
- Source: prnewswire.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- JAZZ headlines on this site
Jazz expects to report results from its Phase 3 study of Modeyso (dordaviprone) for Recurrent H3 K27M-mutant diffuse glioma in the first half of 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
More details
- Entry
- Modeyso ACTION Phase 3 interim OS analysis · Clinical trial results (readout / topline data)
- Drug
- Modeyso (dordaviprone)
- For
- Recurrent H3 K27M-mutant diffuse glioma
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H1 2027 · the company gave a window, not a day
- Source note
- Q2 2026 results: company anticipates the OS interim analysis for the event-driven Phase 3 ACTION trial in 1H27, supporting potential full approval.
- Checked
- Checked by a person when it was added
- Verify it
- Source: prnewswire.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- JAZZ headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page