Jazz Pharmaceuticals plc

Ziihera® (zanidatamab-hrii) Combinations Demonstrate Sustained Survival at Three Years in First-Line HER2+ Advanced Gastroesophageal Adenocarcinoma at ESMO 2026

Jazz Pharmaceuticals reported mature three-year overall survival data from the Phase 3 HERIZON-GEA-01 trial at ESMO 2026, with Ziihera plus tislelizumab and chemotherapy delivering a median OS of 27.0 months versus 19.6 months with trastuzumab plus chemotherapy, the longest reported in a Phase 3 trial in this setting. Ziihera plus chemotherapy alone also achieved a statistically significant OS benefit, reducing the risk of death by 24% (HR 0.76; P=0.0088), and nearly 40% of patients on the triple regimen were alive at three years regardless of PD-L1 status. The data reinforce the August 2026 FDA approvals of two Ziihera-containing regimens for first-line HER2+ gastroesophageal adenocarcinoma; the regimens were recently added as preferred options in NCCN guidelines, strengthening the commercial trajectory of a key Jazz growth asset.

•9d ago

Jazz Pharmaceuticals Completes Acquisition of Actio Biosciences

Jazz Pharmaceuticals completed its acquisition of privately-held Actio Biosciences for $820 million upfront, with Actio now operating as a wholly-owned Jazz subsidiary. The deal adds ABS-1230, an oral, potential first-in-class KCNT1 inhibitor for KCNT1-related epilepsy that carries FDA Fast Track, Rare Pediatric Disease, and Orphan Drug designations and produced meaningful seizure reductions in an early proof-of-concept trial in children. CEO Renee Gala framed the transaction as pairing Actio's precision biology with Jazz's global development capabilities to further diversify the rare-disease pipeline; Actio's non-ABS-1230 programs were spun into an independent private company in which Jazz received a minority stake.

•1mo ago

Ziihera® (zanidatamab-hrii) plus Chemotherapy Demonstrates Statistically Significant Overall Survival Benefit Versus Trastuzumab plus Chemotherapy in First-Line HER2+ Advanced GEA

Jazz Pharmaceuticals announced positive second interim results from the Phase 3 HERIZON-GEA-01 trial, demonstrating that Ziihera plus chemotherapy achieved a statistically significant overall survival benefit compared to trastuzumab plus chemotherapy in first-line HER2+ advanced gastroesophageal adenocarcinoma. The trial, which enrolled 914 patients across more than 30 countries, showed an improved hazard ratio for overall survival, reinforcing Ziihera's superiority over the current standard of care. Management stated these results support Ziihera as the new HER2-targeted backbone therapy and will submit the data for presentation at a major medical meeting in the fourth quarter of 2026.

•2mo ago

U.S. FDA Approves Ziihera® (zanidatamab-hrii) with and without Tislelizumab plus Chemotherapy in First-Line HER2+ Advanced Gastroesophageal Adenocarcinoma

The FDA approved Jazz Pharmaceuticals' Ziihera for two first-line regimens in HER2-positive advanced gastroesophageal adenocarcinoma (GEA), establishing it as the first bispecific HER2-targeted antibody approved in this setting regardless of PD-L1 status. Approval was based on the Phase 3 HERIZON-GEA-01 trial, where the Ziihera combination demonstrated a median overall survival of 26.4 months and median progression-free survival of 12.4 months. The label carries Boxed Warnings for diarrhea and embryo-fetal toxicity; the company noted that diarrhea was the most common adverse reaction in clinical trials.

•2mo ago

Jazz Pharmaceuticals to Acquire Actio Biosciences, Expanding Rare Epilepsy Portfolio

Jazz Pharmaceuticals has agreed to acquire privately-held Actio Biosciences for $820 million upfront and up to $500 million in contingent milestone payments. The transaction centers on ABS-1230, a clinical-stage, potential first-in-class precision therapy for KCNT1+ epilepsy, an ultra-rare disease affecting approximately 2,500 patients in the U.S. with no approved therapies. Jazz will fund the deal using cash on hand and existing credit facilities, while Actio's remaining assets will spin out into a new entity where Jazz will hold a minority stake.

•2mo ago

Jazz Pharmaceuticals Announces Second Quarter 2026 Financial Results

Jazz Pharmaceuticals reported Q2 2026 total revenue of $1.21 billion, up 16% year-over-year, driven by double-digit growth in Xywav and Epidiolex. Non-GAAP EPS came in at $5.71, compared to a year-ago loss, as the company generated $824 million in cash from operations during the first half of the year. Management raised full-year 2026 revenue guidance to $4.60 billion to $4.75 billion, up from the prior range of $4.25 billion to $4.50 billion, reflecting continued momentum across the sleep, epilepsy, and oncology franchises. Product sales were robust, with Xywav increasing 13% to $471 million and Epidiolex rising 16% to $292 million, while Zepzelca sales jumped 42% to $106 million. The company announced a preclinical research collaboration with AbCellera and is preparing for the immediate launch of Ziihera in HER2+ gastroesophageal adenocarcinoma following the FDA's Priority Review designation and PDUFA date of August 25, 2026.

•2mo ago

Jazz Pharmaceuticals and AbCellera Announce Collaboration to Discover Next-Generation T-cell Engaging Multispecific Antibodies

AbCellera entered a preclinical research collaboration and license agreement with Jazz Pharmaceuticals to discover next-generation T-cell engaging multispecific antibodies for gastrointestinal cancers and solid tumors. AbCellera is eligible to receive $56 million in upfront payments for the initial programs, with an additional $28 million due upon initiation of a third program, as well as up to $792 million per program in milestones and tiered royalties on net sales. Jazz holds exclusive options to develop and commercialize therapeutic antibodies resulting from the collaboration, leveraging AbCellera's discovery engine and platform capabilities.

•4mo ago

Jazz Pharmaceuticals Delivers Extensive Late-Breaking Data at SLEEP 2026, Demonstrating Real-World Impact of Xywav® (calcium, magnesium, potassium, and sodium oxybates) on Patient Outcomes Across Narcolepsy and Idiopathic Hypersomnia

Jazz Pharmaceuticals presented 11 late-breaking data presentations at SLEEP 2026, highlighting real-world evidence for Xywav in treating narcolepsy and idiopathic hypersomnia. Key findings from the Phase 4 DUET and XYLO studies showed that individualized dosing achieved stable treatment in approximately 42 days, while switching to the low-sodium formulation was associated with improvements in cardiometabolic risk markers like blood pressure and lipid profiles.

•4mo ago

Jazz Pharmaceuticals to Present Comprehensive Data at SLEEP 2026 Highlighting Broad Treatment Effects of Xywav® (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for People with Narcolepsy and Idiopathic Hypersomnia

Jazz Pharmaceuticals will present 21 abstracts, including 11 late-breaking ones, at SLEEP 2026 in Baltimore. The data highlights the broad treatment effects of Xywav for narcolepsy and idiopathic hypersomnia, focusing on sleep inertia, quality of life, and cardiovascular safety. Xywav remains the only FDA-approved low-sodium oxybate for these conditions, offering 92% less sodium than high-sodium alternatives.

•4mo ago

Phase 3 HERIZON-GEA-01 Results Published in The New England Journal of Medicine Show Durable and Consistent Survival Benefit with Ziihera® (zanidatamab-hrii) Combinations in First-Line HER2+ Locally Advanced or Metastatic GEA

Jazz Pharmaceuticals announced the publication of Phase 3 HERIZON-GEA-01 trial results in The New England Journal of Medicine, confirming durable survival benefits for Ziihera (zanidatamab-hrii) in first-line HER2+ gastroesophageal adenocarcinoma. The data showed superior progression-free survival (12.4 vs 8.1 months) and overall survival (26.4 vs 19.2 months) for zanidatamab plus tislelizumab and chemotherapy compared to trastuzumab plus chemotherapy, with a hazard ratio of 0.72 for OS. Subgroup analyses demonstrated efficacy in both PD-L1-positive and PD-L1-negative patients, including a median OS of 29.7 months in PD-L1-negative patients versus 15.8 months for the control arm, supporting a broad clinical utility for the regimen.

•5mo ago

Jazz Pharmaceuticals Announces First Quarter 2026 Financial Results

Jazz Pharmaceuticals reported Q1 2026 revenue of $1.07 billion, up 19% year-over-year, with non-GAAP EPS of $6.34 versus a prior-year loss. Key growth drivers included Xywav (up 18% to $408M) and Epidiolex (up 15% to $250M), while the oncology portfolio gained momentum with Zepzelca up 60%. The company announced a major regulatory milestone, with the FDA granting Priority Review to zanidatamab for 1L HER2+ GEA with a PDUFA date of August 25, 2026. Jazz reaffirmed its full-year 2026 revenue guidance of $4.25 billion to $4.50 billion.

•5mo ago