Company Description
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharmaceutical company focused on developing and commercializing medicines for people with serious diseases, often where there are limited or no therapeutic options. According to company disclosures, Jazz has a diverse portfolio of marketed medicines, including therapies for sleep disorders, epilepsy and a growing range of oncology treatments. The company emphasizes a patient-focused and science-driven approach, using clinical research and real-world evidence to inform its development programs.
Jazz Pharmaceuticals is headquartered in Dublin, Ireland, with research and development laboratories, manufacturing facilities and employees in multiple countries. Its ordinary shares trade on The Nasdaq Stock Market LLC under the symbol JAZZ, as noted in its SEC filings. Through its global footprint, Jazz states that it is committed to serving patients and families worldwide.
Core therapeutic areas
Jazz reports that its portfolio includes leading therapies for sleep disorders and epilepsy, as well as cancer treatments across several oncology indications. In neuroscience, the company highlights products such as Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for narcolepsy and idiopathic hypersomnia, and Epidiolex/Epidyolex (cannabidiol) oral solution for rare, treatment-resistant epilepsies including Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) and tuberous sclerosis complex (TSC). These medicines are supported by ongoing Phase 4 trials and real-world evidence programs designed to better understand clinical outcomes, comorbidities and treatment patterns.
In oncology, Jazz is advancing therapies in both hematologic and solid tumors. The company describes a growing portfolio of cancer treatments and an expanding clinical program in HER2-driven cancers and central nervous system (CNS) tumors. Ziihera (zanidatamab-hrii), a bispecific HER2-directed antibody, is indicated in the United States for previously treated, unresectable or metastatic HER2-positive biliary tract cancer. Jazz is also developing Ziihera in multiple Phase 2 and Phase 3 trials in HER2-positive gastroesophageal adenocarcinoma (GEA), biliary tract cancer and breast cancer. In neuro-oncology, Modeyso (dordaviprone) is approved in the U.S. for H3 K27M-mutant diffuse midline glioma in adult and pediatric patients one year of age and older with progressive disease following prior therapy.
Neuroscience: sleep disorders and epilepsy
Jazz positions itself as a significant participant in sleep medicine and epilepsy. The company sponsors clinical and real-world studies to evaluate outcomes with Xywav in narcolepsy and idiopathic hypersomnia. Data presented at international congresses have examined sleep architecture, daytime sleepiness, sleep inertia, cardiovascular and cardiometabolic risks associated with sodium intake, and the impact of switching from high-sodium oxybate to low-sodium oxybate regimens.
In epilepsy, Jazz focuses on rare and severe seizure disorders. Epidiolex/Epidyolex (cannabidiol) is described as a plant-derived, highly purified cannabidiol oral solution. In the U.S., Epidiolex is indicated for seizures associated with LGS, DS or TSC in patients one year of age and older. In the European Union, under the tradename Epidyolex, it is approved as adjunctive therapy in conjunction with clobazam for LGS and DS in patients two years and older, and as adjunctive therapy for TSC-associated seizures in patients two years and older. Jazz continues to generate evidence through Phase 3b/4 trials and real-world analyses, including studies on behavioral and non-seizure outcomes, polypharmacy, healthcare resource utilization and pharmacokinetic interactions with other antiseizure medications.
Oncology and HER2-targeted therapies
Oncology is another major pillar of Jazz Pharmaceuticals' business. The company highlights Ziihera (zanidatamab-hrii) as a bispecific HER2-directed antibody that binds two extracellular sites on HER2, leading to receptor internalization and reduction in HER2 expression on tumor cells. Ziihera is reported to induce complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis, resulting in tumor growth inhibition and cell death in preclinical models.
Ziihera has U.S. accelerated approval for adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer, based on overall response rate and duration of response. Jazz, together with partners, is conducting multiple clinical trials to expand the clinical profile of Ziihera, including the Phase 3 HERIZON-GEA-01 trial in first-line HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma, Phase 3 HERIZON-BTC-302 in biliary tract cancer, and trials in metastatic and early-stage HER2-positive breast cancer and other HER2-expressing solid tumors.
Neuro-oncology and rare brain tumors
Jazz is also active in neuro-oncology, particularly in rare and aggressive brain tumors. Modeyso (dordaviprone), formerly known as ONC201, is described as a mitochondrial caseinolytic protease P (ClpP) agonist and dopamine-2 receptor inhibitor. It is administered orally once weekly and is approved in the United States for H3 K27M-mutant diffuse midline glioma in adult and pediatric patients one year of age and older with progressive disease following prior therapy. Jazz reports that dordaviprone has been shown in vitro to activate the integrated stress response, alter mitochondrial metabolism and restore histone H3 K27 trimethylation in H3 K27M-mutant diffuse glioma.
The company supports ongoing clinical and translational research on Modeyso, including the Phase 3 ACTION trial in newly diagnosed H3 K27M-mutant diffuse glioma following radiotherapy, as well as preclinical work on JZP3507 (formerly ONC206) in central nervous system tumors. Presentations at scientific meetings have explored molecular pathways associated with sensitivity to dordaviprone, potential immunomodulatory effects and combination strategies.
Regulatory and corporate profile
Jazz Pharmaceuticals plc is incorporated in Ireland and identified in SEC filings with Commission File Number 001-33500 and an Irish tax registration number. The company files periodic and current reports with the U.S. Securities and Exchange Commission, including Form 8-K filings on material events such as clinical trial results, financial results, corporate governance changes and legal settlements. Its ordinary shares, with a nominal value of $0.0001 per share, are registered under Section 12(b) of the Securities Exchange Act of 1934 and listed on Nasdaq under the symbol JAZZ.
Recent SEC filings describe events such as positive top-line Phase 3 results for Ziihera in HER2-positive gastroesophageal adenocarcinoma, financial results for quarterly periods, changes in executive leadership and board composition, and a global settlement agreement resolving patent and antitrust disputes related to oxybate therapies. These disclosures provide investors with information on Jazz’s clinical, financial and legal developments.
Research, development and scientific engagement
Across its portfolio, Jazz emphasizes research and development in oncology and neuroscience. The company regularly presents data at major medical congresses, including the European Epilepsy Congress, American Epilepsy Society Annual Meeting, World Sleep Congress, Psych Congress, American Society of Clinical Oncology Gastrointestinal Cancers Symposium and the Society for Neuro-Oncology Annual Meeting. Topics span Phase 3 and Phase 4 clinical trials, real-world evidence analyses, pharmacokinetic and pharmacodynamic interaction studies, and translational research.
By focusing on serious diseases such as narcolepsy, idiopathic hypersomnia, rare epilepsies, HER2-positive cancers and H3 K27M-mutant diffuse midline glioma, Jazz Pharmaceuticals positions its pipeline and marketed products toward areas of high unmet medical need. The company’s disclosures highlight the use of both randomized controlled trials and real-world data to evaluate treatment outcomes, safety profiles and broader impacts on patients and caregivers.
Investor considerations
Investors analyzing JAZZ stock can refer to the company’s SEC filings for details on financial performance, risk factors, legal proceedings, corporate governance and capital allocation decisions. Form 8-K filings provide updates on material events, while other periodic reports offer additional context on operations and strategy. Because Jazz operates in highly regulated therapeutic areas and focuses on serious conditions, regulatory approvals, clinical trial outcomes and intellectual property developments are central to its business profile as presented in public disclosures.