Jazz Pharmaceuticals plc
JAZZ evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for JAZZ—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · JAZZ
Jazz Pharmaceuticals plc is a biopharmaceutical company focused on developing and commercializing therapies for serious diseases in neuroscience and oncology, with a portfolio including Xywav, Epidiolex, and Ziihera.
Key risk: Regulatory scrutiny of accelerated approvals
BioSniper Score
Based on 6 of 6 signals
Financial data as of Jun 30, 2026.
Tracking 10 pipeline candidates · 51 clinical trials · 12 catalysts · 6 FDA decisions for Jazz Pharmaceuticals plc.
Jazz Pharmaceuticals plc is a biopharmaceutical company focused on developing and commercializing therapies for serious diseases in neuroscience and oncology, with a portfolio including Xywav, Epidiolex, and Ziihera.
- Jazz Pharmaceuticals has a diverse portfolio of marketed medicines including Xywav, Epidiolex/Epidyolex, Ziihera, Modeyso, and Zepzelca [sec · filed 2024-06-14].
- As of 2026-06-30, the company reported cash & equivalents of $1,619.8M, total revenue of $1,208.3M, and net income of $192.8M [sec].
- The company's strategy focuses on strong commercial execution, advancing R&D programs, and strategic corporate development [sec_mda · as of 2025-11-05].
- Jazz Pharmaceuticals has a robust pipeline with multiple Phase 3 trials underway, including for ONC201 in H3 K27M-mutant diffuse glioma and zanidatamab in combination therapy [upcoming catalysts].
- The company faces risks related to regulatory scrutiny of accelerated approvals, competitive pressures, and the need to successfully commercialize newer products like Ziihera and Modeyso [sec_mda · as of 2026-08-03].
What works
- Jazz Pharmaceuticals has a diverse portfolio of marketed medicines across neuroscience and oncology, including Xywav, Epidiolex, and Ziihera, providing multiple revenue streams [sec · filed 2024-06-14].
- The company maintains a strong cash position of $1,619.8M as of 2026-06-30, which management believes is sufficient to fund operations for the foreseeable future [sec_mda · as of 2026-08-03].
- Jazz is advancing a robust R&D pipeline with several Phase 3 trials, including for ONC201 in diffuse glioma and zanidatamab in HER2-expressing cancers, targeting high unmet medical needs [upcoming catalysts].
What to weigh
- Jazz Pharmaceuticals faces increased regulatory scrutiny over accelerated approvals, which could impact product approvals or lead to market restrictions [sec_mda · as of 2026-08-03].
- The company must overcome competitive, pricing, and reimbursement pressures to successfully commercialize newer products like Ziihera, Modeyso, and Zepzelca [sec_mda · as of 2026-08-03].
- Failure in clinical development or regulatory approval for product candidates could materially affect anticipated revenue and growth prospects [sec_mda · as of 2026-05-05].
From the filings
Quoted directly from source documents.
Jazz Pharmaceuticals has a diverse portfolio of marketed medicines including Xywav, Epidiolex, and Ziihera.
“We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.”
SEC filings · June 14, 2024
The company faces increased regulatory scrutiny over accelerated approvals.
“demonstrated increased scrutiny over accelerated approvals.”
SEC MD&A · August 3, 2026
Management believes existing cash and credit facilities will fund operations for the foreseeable future.
“We believe that our existing cash, cash equivalents and investments balances, cash we expect to generate from operations and funds available under our Amended Revolving Credit Facility will be sufficient to fund our operations and to meet our existing obligations for the foreseeable future.”
SEC MD&A · August 3, 2026
The company's strategy includes strong commercial execution and advancing R&D programs.
“Our strategy to deliver sustainable growth and enhanced value continues to be focused on: • Strong commercial execution to dri”
SEC MD&A · November 5, 2025
Catalyst timeline
- 2026-12-01 · Phase 2 Start: ONC201 for Refractory Meningioma — Initiation of an open-label pilot study for ONC201 in patients with refractory meningioma.
- 2026-12-31 · Phase 2 Start: Nabiximols for Spasticity — Start of a Phase IIb study evaluating nabiximols in subjects with spasticity due to neurological conditions.
- 2027-06-01 · Phase 3 Topline: CPX-351 Combination — Topline results from a randomized Phase III study of intensive chemotherapy with or without CPX-351.
- 2027-07-31 · Phase 3 Topline: Zanidatamab Combination — Topline results from a randomized Phase 3 study of zanidatamab in combination with chemotherapy.
- 2028-01-06 · Phase 3 Topline: Randomized Withdrawal Study — Topline results from a Phase 3 randomized-withdrawal study evaluating an undisclosed therapy.
- 2028-06-01 · Phase 3 Topline: ONC201 for Diffuse Glioma — Topline results from a Phase 3 study of ONC201 for newly diagnosed H3 K27M-mutant diffuse glioma.
- 2028-08-01 · Phase 3 Topline: Undisclosed Indication — Topline results from a Phase 2/3 study evaluating an undisclosed therapy.
- 2029-09-04 · Phase 3 Topline: Undisclosed Indication — Topline results from a Phase 3 placebo-controlled study evaluating an undisclosed therapy.
Risks & what to watch (4)›
Key risks
- Regulatory scrutiny of accelerated approvals — Increased scrutiny could lead to restrictions or withdrawal of products from the market [sec_mda · as of 2026-08-03].
- Commercialization hurdles for new products — Securing formulary status and overcoming pricing pressures for Ziihera, Modeyso, and others is challenging [sec_mda · as of 2026-08-03].
- Clinical development and regulatory failures — Failure to meet endpoints or obtain approvals could materially affect revenue and growth [sec_mda · as of 2026-05-05].
- Dependence on key marketed products — Maintaining sales of Xywav, Epidiolex, and others is critical to financial performance [sec · filed 2026-06-08].
What to watch
- Phase 3 topline results for ONC201 in H3 K27M-mutant diffuse glioma, expected around 2028-06-01 [upcoming catalysts].
- Phase 3 topline results for zanidatamab in combination therapy, expected around 2027-07-31 [upcoming catalysts].
- Phase 2 start for ONC201 in refractory meningioma, expected on 2026-12-01 [upcoming catalysts].
- Commercial performance of recently launched products like Ziihera and Modeyso, given competitive and reimbursement pressures [sec_mda · as of 2026-08-03].
Sources: SEC filings · SEC MD&A · Generated August 29, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 6 of 6 signals · derived from public data
Profitable (positive operating cash flow)
D/E 1.31 · 10% dilution
Lead: Approved
10 candidates
12 upcoming, next in ~93d
0 buys · 17 sells (180d)
Catalysts
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
571
Total value held
$11.32B
| Holder | Shares | Value |
|---|---|---|
| blackrock, inc. | 5,591,700 | $1.06B |
| vanguard capital management llc | 5,296,666 | $1.00B |
| vanguard portfolio management llc | 2,983,242 | $564.0M |
| fmr llc | 2,275,762 | $430.2M |
| franklin resources inc | 1,958,940 | $370.3M |
| dimensional fund advisors lp | 1,895,215 | $358.3M |
| state street corp | 1,891,646 | $357.6M |
| bank of new york mellon corp | 1,679,371 | $317.5M |
| fuller & thaler asset management, inc. | 1,676,142 | $316.9M |
| ameriprise financial inc | 1,608,476 | $304.1M |
Showing top 10 of 571 institutional holders of Jazz Pharmaceuticals plc. Open the full 13F history after sign-in.
Short Interest
as of Apr 30, 2026- % of float
- 9.8%
- Days to cover
- 6.1
- Shares short
- 5,240,459
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
JAZZ short interestGovernance
Frequently asked questions
What is the AI investment thesis for Jazz Pharmaceuticals plc?
Jazz Pharmaceuticals plc is a biopharmaceutical company focused on developing and commercializing therapies for serious diseases in neuroscience and oncology, with a portfolio including Xywav, Epidiolex, and Ziihera.
What is Jazz Pharmaceuticals plc's lead drug candidate?
Jazz Pharmaceuticals plc's most advanced tracked candidate is defitelio (Approved).
What is Jazz Pharmaceuticals plc's next catalyst?
Jazz Pharmaceuticals plc's next tracked catalyst is a Phase2_Start event — "Phase 2 Start: A Pilot Study, Open-Label Study of ONC201 for Refractory Meningioma" — expected December 1, 2026.
Who is the CEO of Jazz Pharmaceuticals plc?
Ms. Renee D. Gala is the chief executive officer of Jazz Pharmaceuticals plc (JAZZ).
Where is Jazz Pharmaceuticals plc headquartered?
Jazz Pharmaceuticals plc (JAZZ) is headquartered in Dublin, Ireland.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.