Jazz Pharmaceuticals plc
JAZZJazz Pharmaceuticals plc (a merger of Jazz Pharmaceuticals, Inc. and Azur Pharma plc) is an American global biopharmaceutical company with a focus on oncology and neuroscience. It was founded in 2003 in California, United States and is now headquartered in Dublin, Ireland.
Drugs in Pipeline
46
Phase 3 Programs
25
Upcoming Catalysts
2
Next Catalyst
This month
Market Overview
Stock performance and key metrics
3 upcoming, 3 past
BLA Filing — Ziihera®
For First-line HER2+ locally advanced or metastatic gastric/esophageal adenocarcinoma (GEA) combinations. Jazz Pharmaceuticals announced FDA acceptance with Priority Review of a supplemental BLA for Ziihera® (zanidatamab-hrii) combinations in first-line HER2+ locally advanced or metastatic gastric/esophageal adenocarcinoma, with a PDUFA decision date of August 25, 2026.
SourcePDUFA — Ziihera
For GEA. Jazz Pharmaceuticals reaffirms its 2026 revenue guidance of $4.25B-$4.5B and targets an August 25, 2026 PDUFA decision date for Ziihera in GEA.
Source1 more catalyst beyond 14 days
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How JAZZ's past catalysts played out
Xyrem (sodium oxybate) oral solution
Fibromyalgia
Nabiximols
Pain
GWP42003-P 20 mg/kg/day Dose
Epilepsy
Xyrem
Narcolepsy With Cataplexy
JZP-110
Obstructive Sleep Apnea
Brincidofovir
Adenovirus Infection
Xyrem®
Fibromyalgia
Dordaviprone (ONC201)
H3 K27M
Sodium Oxybate
Essential Tremor
IM JZP-458
Acute Lymphoblastic Leukemia
GW-1000-02
Pain
Modafinil at established dose
Narcolepsy
Sodium Oxybate & 6 Tablets
Fibromyalgia
Zanidatamab
HER2-positive Breast Cancer
CPX-351
Acute Myeloid Leukemia (AML)
7+3 (cytarabine and daunorubicin)
High Risk Acute Myeloid Leukemia
Defibrotide
Severe Hepatic Veno-Occlusive Disease
experimental anti-anxiety drug
Anxiety Disorder
GW-2000-02
Pain
Sativex
Multiple Sclerosis
a benzodiazepine drug
Anxiety Disorder
JZP-258
Idiopathic Hypersomnia
THC Alone
Palliative Care
Sativex®
Spasticity
GWP42003-P
Epilepsy
Suvecaltamide
Parkinson Disease
ADX-N05
Narcolepsy
Daunorubicin
Acute Myeloid Leukemia
Clobazam
Epilepsy
CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection
Colorectal Neoplasms
Lurbinectedin
Refractory Ewing Sarcoma
GWP42006
Epilepsy
ZW25 (Zanidatamab)
HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
GWP42003
Schizophrenia
Evorpacept
HER2-expressing Cancers
CX-8998
Epilepsy
Clonazepam
Epilepsy
GWP42004
Dyslipidemias
GWP42003-P 5 mg/kg/day Dose
Epilepsy
JZP385
Essential Tremor
Standard of Care
Graft-versus-host Disease
JZP150
Post Traumatic Stress Disorder
ONC206
Advanced Pheochromocytoma and Paraganglioma
Intensive Salvage Therapy
Acute Myeloid Leukemia
Dociparstat sodium
Acute Myeloid Leukemia
asparaginase Erwinia chrysanthemi
Acute Lymphoblastic Leukemia
| Drug Name | Phase | Indication | Designations | Patent |
|---|---|---|---|---|
Xyrem (sodium oxybate) oral solution | Phase 3 | Fibromyalgia | - | - |
Nabiximols | Phase 3 | Pain | - | - |
GWP42003-P 20 mg/kg/day Dose | Phase 3 | Epilepsy | - | - |
Xyrem | Phase 3 | Narcolepsy With Cataplexy | - | - |
JZP-110 | Phase 3 | Obstructive Sleep Apnea | - | - |
Brincidofovir | Phase 3 | Adenovirus Infection | - | - |
Xyrem® | Phase 3 | Fibromyalgia | - | - |
Dordaviprone (ONC201) | Phase 3 | H3 K27M | - | - |
Sodium Oxybate | Phase 3 | Essential Tremor | - | - |
IM JZP-458 | Phase 3 | Acute Lymphoblastic Leukemia | - | - |
GW-1000-02 | Phase 3 | Pain | - | - |
Modafinil at established dose | Phase 3 | Narcolepsy | - | - |
Sodium Oxybate & 6 Tablets | Phase 3 | Fibromyalgia | - | - |
Zanidatamab | Phase 3 | HER2-positive Breast Cancer | - | - |
CPX-351 | Phase 3 | Acute Myeloid Leukemia (AML) | - | - |
7+3 (cytarabine and daunorubicin) | Phase 3 | High Risk Acute Myeloid Leukemia | - | - |
Defibrotide | Phase 3 | Severe Hepatic Veno-Occlusive Disease | - | - |
experimental anti-anxiety drug | Phase 3 | Anxiety Disorder | - | - |
GW-2000-02 | Phase 3 | Pain | - | - |
Sativex | Phase 3 | Multiple Sclerosis | - | - |
a benzodiazepine drug | Phase 3 | Anxiety Disorder | - | - |
JZP-258 | Phase 3 | Idiopathic Hypersomnia | - | - |
THC Alone | Phase 3 | Palliative Care | - | - |
Sativex® | Phase 3 | Spasticity | - | - |
GWP42003-P | Phase 3 | Epilepsy | - | - |
Suvecaltamide | Phase 2 | Parkinson Disease | - | - |
ADX-N05 | Phase 2 | Narcolepsy | - | - |
Daunorubicin | Phase 2 | Acute Myeloid Leukemia | - | - |
Clobazam | Phase 2 | Epilepsy | - | - |
CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection | Phase 2 | Colorectal Neoplasms | - | - |
Lurbinectedin | Phase 2 | Refractory Ewing Sarcoma | - | - |
GWP42006 | Phase 2 | Epilepsy | - | - |
ZW25 (Zanidatamab) | Phase 2 | HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer | - | - |
GWP42003 | Phase 2 | Schizophrenia | - | - |
Evorpacept | Phase 2 | HER2-expressing Cancers | - | - |
CX-8998 | Phase 2 | Epilepsy | - | - |
Clonazepam | Phase 2 | Epilepsy | - | - |
GWP42004 | Phase 2 | Dyslipidemias | - | - |
GWP42003-P 5 mg/kg/day Dose | Phase 2 | Epilepsy | - | - |
JZP385 | Phase 2 | Essential Tremor | - | - |
Standard of Care | Phase 2 | Graft-versus-host Disease | - | - |
JZP150 | Phase 2 | Post Traumatic Stress Disorder | - | - |
ONC206 | Phase 2 | Advanced Pheochromocytoma and Paraganglioma | - | - |
Intensive Salvage Therapy | Phase 2 | Acute Myeloid Leukemia | - | - |
Dociparstat sodium | Phase 2 | Acute Myeloid Leukemia | - | - |
asparaginase Erwinia chrysanthemi | Phase 2 | Acute Lymphoblastic Leukemia | - | - |
Epilepsy
3 drugs in this indication
Refractory Ewing Sarcoma
1 drug in this indication
Multiple Sclerosis
1 drug in this indication
Pain
1 drug in this indication
Parkinson Disease
1 drug in this indication
Spasticity
1 drug in this indication
Narcolepsy With Cataplexy
1 drug in this indication
Source: CatalystAlert database (ClinicalTrials.gov, SEC EDGAR)
Full breakdown — the signals behind the verdict
Frequently asked questions
What is in Jazz Pharmaceuticals plc's drug pipeline?→
CatalystAlert tracks 46 drug candidates in Jazz Pharmaceuticals plc's (JAZZ) pipeline across Phase 3, Phase 2. Its lead program is Xyrem (sodium oxybate) oral solution (Phase 3). Each drug's phase, indication and upcoming catalysts are listed on this page.
When is Jazz Pharmaceuticals plc's next FDA catalyst?→
Jazz Pharmaceuticals plc's (JAZZ) next tracked catalyst is a Phase 3 expected August 15, 2026. See the catalyst timeline on this page for the full schedule of PDUFA dates, trial readouts and FDA events.
How do I track JAZZ biotech catalysts?→
Add JAZZ to your CatalystAlert watchlist for alerts ahead of each catalyst, and follow Jazz Pharmaceuticals plc's live catalyst calendar, drug pipeline and clinical-trial timeline on this page — sourced from ClinicalTrials.gov, FDA and SEC filings.