Jazz Pharmaceuticals plc JAZZ
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a CNS/neurology/psychiatry drug developer. Its lead program, JZP6979 (ABS-1230), is in Phase 2 for KCNT1-related epilepsy.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Zanidatamab (Ziihera) | First-line HER2-positive gastroesophageal adenocarcinoma (ZOLA trial) | antibody | Phase 3 |
| Zanidatamab | First-line HER2-positive biliary tract cancer (HERIZON-BTC-302 confirmatory) | antibody | Phase 3 |
| Zanidatamab | HER2-positive breast cancer post-T-DXd (EmpowHER-BC-303) | antibody | Phase 3 |
| Dordaviprone (Modeyso) | First-line H3 K27M-mutant diffuse glioma (ACTION confirmatory) | small molecule | Phase 3 |
| Cannabidiol oral solution (Epidiolex) | Adults with LGS (Phase 3b/4) | small molecule | Phase 3 |
| Cannabidiol oral solution | Developmental and epileptic encephalopathy | small molecule | Phase 3 |
| JZP6979 (ABS-1230) | KCNT1-related epilepsy | small molecule | Phase 2 |
| Cannabidiol capsule formulation | Juvenile myoclonic epilepsy | small molecule | Phase 2 |
| JZP815 | Raf and Ras mutant tumors | small molecule | Phase 1 |
| JZP898 (WTX-613) | Solid tumors (conditionally-activated IFNα) | protein/peptide | Phase 1 |
| JZP3507 (ONC206) | Recurrent and rare primary CNS tumors | small molecule | Phase 1 |
| JZP269 | Narcolepsy and idiopathic hypersomnia | small molecule | Phase 1 |
Recent results and decisions
- Nov 2, 2026positive Final analysis of HERIZON-GEA-01 trial showed sustained survival benefit at three years with OS hazard ratio of 0.65.
Longer follow up of Ziihera plus tislelizumab and chemotherapy showed an improved overall survival (OS) hazard ratio of 0.65, further supporting Ziihera-based combinations as standard-of-care.
Filing - Sep 30, 2026approval FDA approved Zepzelca label supplement removing the second-line indication on September 30, 2026.
On September 30, 2026, the FDA approved the label supplement removing the second-line indication.
Filing - Aug 25, 2026approval FDA approved Ziihera plus tislelizumab and chemo (IHC 3+ and 2+/ISH+) and Ziihera plus chemo (IHC 3+) for first-line HER2+ GEA; median OS 26.4 vs 19.2 months and median PFS 12.4 vs 8.1 months in the pivotal trial.
today announced that the U.S. Food and Drug Administration (FDA) approved two Ziihera® (zanidatamab-hrii)-containing regimens for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive (HER2+) gastroesophageal adenocarcinoma (GEA)
Filing
1 more on record.
For subscribers
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Other phase 2 CNS/neurology/psychiatry companies
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Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.