Jazz Pharmaceuticals raised its full-year 2026 revenue guidance to $4.60 billion to $4.75 billion, up from a prior range of $4.25 billion to $4.50 billion, ahead of an FDA decision on zanidatamab for HER2-positive gastric cancer due August 25.
The company disclosed the updated guidance in second-quarter earnings announced August 4. Zanidatamab, a HER2-targeting bispecific antibody, faces an FDA priority review for use in combination therapies in first-line HER2-positive locally advanced or metastatic gastric and gastroesophageal adenocarcinoma. A priority review typically takes six months from acceptance; the FDA accepted the application for review April 27, setting the August 25 decision date.
Jazz acquired zanidatamab through its 2024 purchase of Zymeworks for $493 million. The asset represents one of the company's late-stage pipeline candidates and a potential revenue driver in oncology, a focus area for the Dublin-based drugmaker as it manages legacy liability settlements from its opioid exposure. Jazz previously disclosed zanidatamab development with Amgen in a co-development agreement signed in 2023.
The $350 million midpoint increase in guidance represents a 4 percent jump from the prior midpoint of $4.375 billion. Jazz's broader portfolio includes Xyrem, Xywav, and Oncaspar, though the company has faced manufacturing constraints and competitive pressure in narcolepsy treatments. Second-quarter results showed Jazz missed earnings estimates by $0.47 per share, according to market data.
Gastric cancer represents a significant market opportunity in Asia and Europe, where incidence is highest. Zanidatamab competes in a space with limited approved targeted therapies; if approved on August 25, the asset would compete with ramucirumab and trastuzumab-based regimens already in use. Jazz faces a three-week window before the PDUFA decision to finalize manufacturing and supply readiness.
The guidance raise depends entirely on zanidatamab's FDA approval and subsequent uptake. If the agency issues a complete response letter or requests additional data, Jazz would likely need to revise its 2026 outlook downward. The August 25 PDUFA decision will determine whether zanidatamab reaches the market on the timeline Jazz has now embedded into full-year earnings expectations.
