Jazz scores front-line gastric cancer nod from FDA for ‘practice-changing’ Ziihera
Jazz scores front-line gastric cancer nod from FDA for ‘practice-changing’ Ziihera
Jazz Pharmaceuticals
Jazz Pharmaceuticals is a global biopharmaceutical company focused on neuroscience and oncology, with a commercial portfolio that includes Xywav (low-sodium oxybate), Epidiolex (cannabidiol), and Zepzelca (lurbinectedin). The company markets Zepzelca in the U.S. under license from PharmaMar and is facing renewed questions about the drug's accelerated approval in small cell lung cancer after a confirmatory Phase 3 trial failed to meet its primary endpoint.
Company Info
Sector:Pharmaceutical / Specialty Therapeutics (Neuroscience & Oncology)
Headquarters:Dublin, Ireland (with U.S. operations in Palo Alto, California and Philadelphia, Pennsylvania)
Founded:2003
Website:www.jazzpharma.com/
Upcoming Milestones & Key Dates
H2 2026
Regulatory
FDA Oncologic Drugs Advisory Committee on Zepzelca confirmatory data and accelerated approval status
Q3 2026
Earnings
Q2 2026 earnings and Zepzelca commercial update
Clinical Development Pipeline
Zepzelca (lurbinectedin)
Target: Marine-derived alkylating agent binding DNA minor grooveXywav (calcium, magnesium, potassium, and sodium oxybates)
Target: GABA-B receptor modulation (low-sodium oxybate formulation)Epidiolex/Epidyolex (cannabidiol)
Target: Plant-derived cannabinoid (non-psychoactive)Recent News
New Jazz cancer drug approval could drive blockbuster sales
New Jazz cancer drug approval could drive blockbuster sales
FDA approves Jazz's Ziihera in frontline gastric cancer
The FDA has approved Jazz Pharmaceuticals' Ziihera for frontline treatment of gastric cancer, a potential blockbuster indication.
Jazz bets on epilepsy again by acquiring Actio for $820M upfront
Jazz bets on epilepsy again by acquiring Actio for $820M upfront
Jazz commits up to $1.3B to buy Actio, bolster epilepsy pipeline
Jazz commits up to $1.3B to buy Actio, bolster epilepsy pipeline
Jazz pays $820M to add epilepsy-focused Actio to its orchestra
Jazz pays $820M to add epilepsy-focused Actio to its orchestra
Jazz to withdraw Zepzelca in second-line small cell lung cancer
Jazz Pharmaceuticals will withdraw Zepzelca from the second-line small cell lung cancer setting after a confirmatory trial failure.
Jazz Pharma Expands Again in Epilepsy With $820M Actio Bio Acquisition
Jazz Pharma Expands Again in Epilepsy With $820M Actio Bio Acquisition
Jazz orchestrates a $4bn cancer alliance with AbCellera
Jazz orchestrates a $4bn cancer alliance with AbCellera.
Zepzelca Saga Takes Another Turn With Ph. 3 Lung Cancer Flop
Jazz Pharmaceuticals and partner PharmaMar's Zepzelca (lurbinectedin) has failed a confirmatory Phase 3 study in small cell lung cancer, raising fresh questions about the drug's accelerated approval and Jazz's oncology strategy.
Leadership Team
Renee Gala
President and Chief Executive Officer (since July 2025)