JAZZ Filings — Jazz Pharmaceuticals Plc - FilingSpy
JAZZ
Jazz Pharmaceuticals Plc
A global biopharmaceutical company focused on rare diseases, Jazz Pharmaceuticals makes medicines for sleep disorders, epilepsy, and cancer. Its flagship products include Xywav for narcolepsy, Epidiolex for rare epilepsies, and the newer oncology drugs Ziihera and Modeyso. Founded in 2003 by Bruce Cozadd, the company took its name from the idea of jazz improvisation — innovating freely while staying grounded in a shared structure, much like musicians jamming together on stage.
FDA approves Ziihera-based regimens for first-line HER2+ gastroesophageal adenocarcinoma
On August 25, 2026, Jazz Pharmaceuticals announced FDA approval of Ziihera (zanidatamab-hrii) plus Tevimbra (tislelizumab-jsgr) and chemotherapy for first-line HER2+ GEA (IHC 3+ and IHC 2+/ISH+), and Ziihera plus chemotherapy for HER2+ IHC 3+ GEA.
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The approval is based on the Phase 3 HERIZON-GEA-01 trial, which showed a median overall survival of 26.4 months versus 19.2 months for trastuzumab plus chemotherapy, a 28% reduction in risk of death.
The Ziihera plus tislelizumab and chemotherapy regimen reduced the risk of disease progression or death by 35%, with median progression-free survival of 12.4 months versus 8.1 months.
Ziihera is described as the first and only bispecific HER2-targeted antibody combined with a PD-1 inhibitor and chemotherapy approved for all HER2+ advanced GEA patients regardless of PD-L1 status.
The U.S. Prescribing Information for Ziihera includes Boxed Warnings for diarrhea and embryo-fetal toxicity; the company will host an investor webcast on August 25, 2026 at 4:30 p.m. ET.
Jazz Pharmaceuticals to acquire Actio Biosciences for $820M upfront plus $500M in milestones.
The acquisition adds ABS-1230, a clinical-stage, potential first-in-class KCNT1 ion channel inhibitor for KCNT1+ epilepsy, an ultra-rare disease with no approved therapies.
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Jazz Pharmaceuticals and Actio Biosciences entered a definitive agreement for Jazz to acquire Actio for $820 million upfront and up to $500 million in contingent consideration.
ABS-1230 has FDA Fast Track, Rare Pediatric Disease, and Orphan Drug Product designations and was accepted into the FDA's Rare Disease Evidence Principles program.
Actio Biosciences will spin out a new privately-held entity focused on genetic rare neurological diseases, including ABS-0871 for Charcot-Marie-Tooth type 2C, with Jazz receiving a minority stake.
The transaction was unanimously approved by both boards and is expected to close by the fourth quarter of 2026, subject to customary closing conditions.
7.01 Regulation FD Disclosure · 9.01 Financial Statements and Exhibits
Jazz Pharmaceuticals to acquire Actio Biosciences for $820M upfront plus up to $500M in milestones
Jazz Pharmaceuticals, Inc., a wholly owned subsidiary of Jazz Pharmaceuticals plc, entered into a merger agreement on August 10, 2026, to acquire Actio Biosciences, Inc. via a merger of its subsidiary Knight Acquisition Corp. with and into Actio.
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The aggregate upfront transaction value is based on an initial amount of $820,000,000, subject to customary adjustments for cash, debt, transaction expenses, and other items.
Holders of Actio capital stock, options, and warrants are eligible for contingent milestone payments of up to $500,000,000 in the aggregate, tied to regulatory approval and sales milestones for ABS-1230 in KCNT1-Related Epilepsy.
Prior to closing, Actio will spin out certain non-ABS-1230 programs into a newly formed company (SpinCo), in which Jazz will hold a minority equity stake.
Closing is subject to conditions including HSR waiting period expiration, stockholder approval by at least 85% of outstanding shares, completion of the Spin-Out Transaction, and other customary conditions; no termination fees are contemplated.
1.01 Entry into a Material Definitive Agreement · 9.01 Financial Statements and Exhibits
Earnings8-K
Jazz Pharmaceuticals reports record Q2 2026 revenues of $1.2 billion, raises 2026 guidance
GAAP EPS was $2.78; non-GAAP adjusted EPS was $5.71.
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Total revenues for Q2 2026 were $1.2 billion, up 16% year-over-year.
Xywav net sales grew 13% to $471 million; Epidiolex grew 16% to $292 million.
Company raised 2026 revenue guidance to $4.60-$4.75 billion.
FDA PDUFA date for zanidatamab in HER2+ 1L GEA is August 25, 2026.
2.02 Results of Operations and Financial Condition · 9.01 Financial Statements and Exhibits
Jazz Pharmaceuticals shareholders elect three directors and approve all five voted proposals at 2026 annual meeting.
At the July 23, 2026 annual meeting, shareholders elected Bruce C. Cozadd, Heather Ann McSharry, and Rick E Winningham as directors to serve until the 2029 annual meeting.
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Shareholders ratified KPMG, Dublin as independent auditors for fiscal year 2026 and authorized the board/audit committee to set auditor remuneration.
The non-binding advisory vote on named executive officer compensation was approved.
Shareholders granted the board authority to allot and issue ordinary shares, and to issue shares for cash without pre-emption rights, under Irish law.
A proposal to adjourn the meeting was not put to a vote because no adjournment was needed.
5.07 Submission of Matters to a Vote of Security Holders
Jazz Pharmaceuticals reports record 2025 revenue of $4.3 billion, up 5% YoY
Full year 2025 total revenues were $4.3 billion, a 5% increase year-over-year; fourth quarter 2025 revenues were $1.2 billion, up 10% YoY.
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GAAP net loss for 2025 was $356 million, compared to net income of $560 million in 2024; non-GAAP adjusted net income was $522 million, down from $1.35 billion.
Xywav net product sales grew 12% to $1.7 billion in 2025; Epidiolex/Epidyolex grew 9% to $1.1 billion.
Modeyso generated $48 million in 2025 sales, including $37 million in 4Q25, its first full quarter on the market.
Company expects 2026 total revenues of $4.25 to $4.50 billion.
Zanidatamab sBLA submission for HER2+ 1L GEA expected in 1Q26 under RTOR, with potential launch in 2H26.
2.02 Results of Operations and Financial Condition · 9.01 Financial Statements and Exhibits