FDA accepts Ziihera 1L GEA sBLA with priority review; PDUFA Aug 25, 2026
FDA accepts Ziihera 1L GEA sBLA with priority review; PDUFA Aug 25, 2026, on Apr 27, 2026. A company milestone for Jazz (Ziihera (zanidatamab-hrii) for 1L HER2+ locally advanced or metastatic GEA): a step in the program rather than a decision or a data readout.
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
- 1L HER2+ locally advanced or metastatic GEA
- Stage
- Regulatory (sBLA)
- When
- Apr 27, 2026
- Source note
- FDA accepted for filing with Priority Review the sBLA for zanidatamab-containing combinations in first-line HER2-positive advanced gastric/GEJ/gastroesophageal adenocarcinoma, supported by the pivotal HERIZON-GEA-01 trial, and set a PDUFA target action date of August 25, 2026.
- Checked
- Checked by a person when it was added
- Source: investor.jazzpharma.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
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