Jazz Pharmaceuticals plc

JAZZ

Held by 7 specialist biotech funds

High Convergence

7 funds opened new positions. Next phase2 readout (Glasdegib): Jun 2024. Short interest: 6.5% of float.

BiotechnologyCEO: Renee D. GalaIPO: 2007Website ↗

Jazz Pharmaceuticals plc, a biopharmaceutical company, identifies, develops, and commercializes pharmaceutical products for various unmet medical needs in the United States, Europe, and internationally. The company has a portfolio of products and product candidates with a focus in the areas of neuroscience, including sleep medicine and movement disorders; and in oncology, including hematologic and solid tumors. Its lead marketed products include Xyrem, an oral solution for the treatment of cataplexy and excessive daytime sleepiness (EDS) in narcolepsy patients seven years of age and older; Sunosi for the treatment of EDS in patients with narcolepsy and obstructive sleep apnea; Erwinaze to treat acute lymphoblastic leukemia; Defitelio for the treatment of adult and pediatric patients with hepatic veno-occlusive disease; Vyxeos liposome for injection, a product for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia; and Zepzelca for the treatment of adult patients with metastatic small cell lung cancer. The company also offers Xywav, an oxybate product candidate, to treat EDS and cataplexy with narcolepsy and idiopathic hypersomnia; JZP-324, a low sodium oxybate formulation with the potential to provide a clinically meaningful option for narcolepsy patients; JZP385, a T-type calcium channel modulator, for the treatment of essential tremor; JZP458, a recombinant Erwinia asparaginase, for use as a component of a multi-agent chemotherapeutic regimen in the treatment of pediatric and adult patients; and JZP150 for treatment of post-traumatic stress disorder. The company has licensing and collaboration agreements with ImmunoGen, Inc.; Codiak BioSciences, Inc.; Pfenex, Inc.; XL-protein GmbH; and Redx Pharma plc. Jazz Pharmaceuticals plc was incorporated in 2003 and is headquartered in Dublin, Ireland.

Catalysts

Phase 2Q4 2008ClonazepamEpilepsyNCT00594945

Primary: Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%). (Change from baseline to treatment day)Enrollment:45/45Sites: 6NON_RANDOMIZED, TREATMENT

Phase 2PositiveQ2 2010CPX-351Acute Myeloid LeukemiaNCT00788892

Primary: Number of Participants With Complete Remission (Within 6 weeks of the last induction treatment)Enrollment:126/126Sites: 28RANDOMIZED, TREATMENT

Phase 3Q1 2016NabiximolsPain, Advanced CancerNCT01337089

Primary: Percent Of Participants With Treatment-emergent Adverse Events (Baseline, Day 183)Enrollment:660/660Sites: 128NA, TREATMENT

Phase 3PositiveQ3 2016DefibrotideHepatic Veno-Occlusive DiseaseNCT00628498

Primary: Survival by Day+100 Post Stem Cell Transplant or Chemotherapy (Day +100 from HSCT or 100 days from start of chemotherapy)Enrollment:1,206/1,206Sites: 125NA, TREATMENT

Phase 2Q2 2017CPX-351Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS)NCT02269579

Primary: Total Drug Plasma PK (Pre-dose and up to Day 21 during first induction only)0Sites: 5NA, TREATMENT

Phase 2Q3 2018JZP-110Excessive Sleepiness, Parkinson DiseaseNCT03037203

Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation (Up to Day 35)Enrollment:66/66Sites: 25RANDOMIZED, DOUBLE, TREATMENT

Phase 2Q4 2023JZP150Post Traumatic Stress DisorderNCT05178316

Phase 2Jun 30, 2024GlasdegibAcute Myelogenous Leukemia (AML) Due to Therapy, Acute Myeloid Leukemia With Myelodysplasia-Related ChangesNCT04231851

Phase 3Jul 29, 2024AtezolizumabSmall-Cell Lung CancerNCT05091567

Phase 2Sep 1, 2024DefibrotideCovid19NCT04652115

Phase 2Sep 1, 2024Enasidenib MesylateRecurrent Acute Myeloid LeukemiaNCT03825796

Phase 2Apr 10, 2025Liposome-encapsulated Daunorubicin-CytarabineAcute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Secondary Acute Myeloid LeukemiaNCT04269213

Phase 2Jun 6, 2025Liposome-encapsulated Daunorubicin-CytarabineAcute Myeloid Leukemia, Myeloid NeoplasmNCT04195945

Phase 2Aug 28, 2025CPX-351Myeloid NeoplasmNCT05656248

Phase 2Q2 2026NabiximolsGlioblastoma, Brain Tumor, CannabisNCT05629702

Phase 2Jun 30, 2026PaclitaxelGastroesophageal AdenocarcinomaNCT06043427

Phase 2Q3 2026LurbinectedinAdvanced Soft-tissue Sarcoma, Metastatic Soft-tissue Sarcoma, Advanced LeiomyosarcomaNCT05099666

Phase 3Q3 2026ZanidatamabGastric Neoplasms, Gastroesophageal Adenocarcinoma, Esophageal AdenocarcinomaNCT05152147

Phase 2Q4 2026ZanidatamabBreast Cancer, Gastric Cancer, Esophageal CancerNCT06695845

Phase 2Q4 2026CPX-351Acute Myeloid Leukemia (AML) in RemissionNCT04990102

Phase 2Q1 2027CannabidivarinAutism Spectrum DisorderNCT03202303

Phase 3Q2 2027CytarabineAcute Myeloid LeukemiaNCT03897127

Phase 2Jul 30, 2027LurbinectedinEwing Sarcoma, Desmoplastic Small Round Cell Tumor, Pediatric CancerNCT05918640

Phase 2Dec 1, 2027CBD Oral SolutionFragile X SyndromeNCT06261502

Phase 2Dec 15, 2027CBD Oral Solution (eCBD system Target)Fragile X SyndromeNCT06261450

Phase 3Q4 2027XywavNarcolepsy, Idiopathic HypersomniaNCT07625280

Phase 2Dec 31, 2027ONC201Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant, Recurrent Diffuse Intrinsic Pontine GliomaNCT05009992

Phase 2Q1 2028ZanidatamabHER2-positive Breast Cancer, Breast CancerNCT07102381

Phase 2Q1 2028LurbinectedinRefractory Ewing Sarcoma, Relapsed Ewing Sarcoma, Ewing SarcomaNCT05734066

Phase 2Q1 2028LurbinectedinExtensive-stage Small-cell Lung CancerNCT07459634

Phase 2Jan 31, 2028Asparaginase Erwinia chrysanthemiB Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, T Acute Lymphoblastic LeukemiaNCT06738368

Phase 2Mar 13, 2028ZanidatamabNon-Small Cell Lung Cancer, Sarcoma, Head &Amp; Neck CancerNCT07192068

Phase 3Q2 2028ZanidatamabMetastatic HER2-positive Breast CancerNCT06435429

Phase 2Jun 1, 2028TislelizumabGastroesophageal AdenocarcinomaNCT07290985

Phase 3Q2 2028Dordaviprone (ONC201)H3 K27M, GliomaNCT05580562

Phase 2Aug 2, 2028Cytarabine and IdarubicinAcute Myeloid LeukemiaNCT05260528

Phase 3Q3 2028EverolimusDiffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Midline Glioma, H3K27-alteredNCT05476939

Phase 2Q4 2028JZP3507MeningiomaNCT07533942

Phase 3Q4 2028ZanidatamabBiliary Tract CancerNCT06282575

Phase 2Q4 2028ONC206Advanced Pheochromocytoma and Paraganglioma, PCPGNCT07282587

Phase 2Q1 2029ZanidatamabGastroesophageal Adenocarcinoma, First Line Therapy, HER2 + Gastric CancerNCT07176312

Phase 2Q2 2029LurbinectedinSmall Cell Lung Cancer ( SCLC ), Transformed Small Cell Lung CancerNCT07153055

Phase 3Dec 1, 2029Cannabidiol (CBD)Clinical High Risk for Psychosis (CHR), Clinical High Risk for Psychosis, Clinical High Risk for Developing PsychosisNCT07434973

Phase 2Feb 28, 2030CannabidiolEarly Life Adversity, Trauma, StressNCT07278505

Recent News & Research

PubMed

Transportability of tislelizumab trial outcomes from RATIONALE-315, RATIONALE-303, and RATIONALE-312 to the European population in early-stage non-small cell lung cancer (NSCLC), advanced NSCLC and extensive-stage small cell lung cancer (ES-SCLC).

# Investment Summary: Tislelizumab Transportability Analysis **Clinical Finding:** This analysis examines whether efficacy and safety data from tislelizumab trials (a PD-L1 inhibitor) can be reliably applied to European patient populations across early-stage NSCLC, advanced NSCLC, and ES-SCLC—addressing a key regulatory requirement for European market expansion. **Commercial Implication:** Successful transportability validation would support Jazz's European regulatory submissions and label expansion, potentially unlocking significant market access in these large oncology indications. Conversely, poor transportability could require additional European trials, delaying market entry and increasing development costs in a competitive immunotherapy landscape. **Why It Matters:** Regulatory agencies increasingly scrutinize whether non-European trial populations adequately represent regional patient populations; this analysis directly impacts Jazz's ability to efficiently convert clinical data into approved European ind

Jul 7, 2026

bioRxiv

mTOR inhibition augments antitumor immune effector response by reprogramming the TP53-mutant, immune-cold HNSCC tumor microenvironment.

# Jazz Pharmaceuticals Investment Summary **Clinical/Commercial Relevance:** This preclinical research demonstrates that mTOR inhibition can convert immunologically "cold" head and neck squamous cell carcinomas (HNSCC)—particularly TP53-mutant tumors resistant to checkpoint inhibitors—into immunologically "hot" tumors, potentially enabling combination therapy approaches. Jazz's mTOR inhibitor portfolio (notably everolimus) could be repositioned to address the significant unmet need in TP53-mutant HNSCC, a subset that currently shows poor response to standard immunotherapy and represents a commercially valuable patient stratification opportunity. If validated in clinical studies, this mechanism could expand Jazz's addressable market in oncology and provide rational combination strategies with checkpoint inhibitors or other immunotherapies. **Investor Consideration:** This is early-stage (preprint) research requiring IND enabling studies and clinical validation; success

Jun 8, 2026

PubMed

Atezolizumab versus pembrolizumab in the treatment of advanced triple-negative breast cancer: a Bayesian network meta-analysis of ITT and PD-L1 positive populations.

# Jazz Pharmaceuticals Investment Summary I cannot provide an analysis of this article because it appears to be a future publication (dated May 29, 2026) that does not yet exist in the scientific literature. Additionally, the comparison between atezolizumab and pembrolizumab would not directly impact Jazz Pharmaceuticals' pipeline or commercial position, as Jazz's oncology portfolio does not include these checkpoint inhibitors as core assets. To provide useful analysis, I would need: 1. A published article with verifiable date and journal citation 2. Research directly relevant to Jazz's marketed drugs (e.g., Defitelio, Vyxeos) or clinical-stage candidates 3. Data showing competitive, regulatory, or market access implications for Jazz's specific programs If you have a different Jazz-relevant oncology study you'd like analyzed, please share those details.

May 29, 2026

PubMed

Correction: CPX-351 vs. conventional chemotherapy cardiotoxicity in high-risk AML: a post hoc phase III trial analysis.

# Investment Summary: Jazz Pharmaceuticals CPX-351 Cardiotoxicity Data **Clinical Finding:** This post hoc analysis of phase III trial data demonstrates that CPX-351 (Jazz's liposomal daunorubicin/cytarabine combination) shows a favorable cardiotoxicity profile compared to conventional chemotherapy in high-risk acute myeloid leukemia (AML) patients, a key safety differentiator for the aging AML population. **Commercial Relevance:** The cardiotoxicity advantage supports CPX-351's positioning in first-line AML treatment, potentially expanding eligible patient populations and justifying premium pricing in a competitive landscape where safety profiles increasingly influence formulary decisions and physician adoption. **Investor Consideration:** This safety data reinforces a key clinical justification for CPX-351's market position, though the post hoc nature of the analysis and publication timing (2026)

May 23, 2026

bioRxiv

The discovery of missing taxane C13α-O-deacetylases re-delineates the biosynthetic pathway of paclitaxel

# Investment Summary: Jazz Pharmaceuticals & Paclitaxel Biosynthesis I cannot provide an accurate analysis because this article is dated May 23, 2026—a future date beyond my knowledge cutoff of April 2024. I'm unable to access or verify this paper's existence or contents. **For proper due diligence, I'd recommend:** - Confirming the actual publication date and journal - Reviewing whether Jazz has disclosed any biosynthetic pathway developments in recent earnings calls or SEC filings - Assessing commercial relevance: paclitaxel is a mature generic drug, so biosynthetic improvements would only matter if they reduce manufacturing costs or enable novel formulations/derivatives that Jazz commercializes If you can provide the correct date or details, I'm happy to analyze the actual clinical and commercial implications.

May 23, 2026

Jazz Pharmaceuticals plc

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