Zymeworks Inc. and its commercial partners Jazz Pharmaceuticals and BeOne Medicines announced topline data from the HERIZON‑GEA‑01 trial, showing that Ziihera (zanidatamab‑hrii) combined with standard chemotherapy, with or without the PD‑1 inhibitor Tevimbra, produced statistically significant improvements in progression‑free survival and overall survival compared with trastuzumab plus chemotherapy in patients with first‑line HER2‑positive gastroesophageal adenocarcinoma. The combination of Ziihera and chemotherapy yielded a clinically meaningful benefit, and the addition of Tevimbra further enhanced overall survival, indicating a synergistic effect with immune checkpoint inhibition.
The trial’s results support Jazz’s plan to file a supplemental Biologics License Application in the first half of 2026 and to present the data at a major medical meeting in the first quarter of 2026. The findings also lay the groundwork for publication in a peer‑reviewed journal and for inclusion in National Comprehensive Cancer Network guidelines, positioning Ziihera as a potential new standard of care in this indication.
Financially, the Q3 2025 results show revenue of $27.6 million, up 72% from $16.0 million in Q3 2024, largely driven by a $25 million milestone payment from Jazz. Net loss narrowed to $19.6 million from $29.9 million year‑over‑year, reflecting improved operating efficiency. Cash and cash equivalents stood at $299.4 million as of September 30 2025, providing a runway to support ongoing development and potential commercialization. The company’s full‑year 2024 revenue was $76.3 million with a net loss of $122.7 million, underscoring the importance of the new clinical milestone for future revenue streams.
Investors reacted strongly to the data, reflecting confidence in Ziihera’s potential to change practice. The statistically significant progression‑free and overall survival benefits were cited as the primary driver of the positive market reaction, underscoring the importance of the clinical milestone for the company’s valuation and future growth prospects.
Rob Iannone, Jazz’s head of R&D, said, “These results will be practice‑changing. We expect Ziihera to become the new standard of care anti‑HER2 therapy for patients with HER2+ first‑line metastatic GEA regardless of PD‑L1 status.” Kenneth Galbraith, Zymeworks CEO, highlighted the company’s progress in its ADC platform and the clinical success of Ziihera, noting that the trial results reinforce the company’s strategy to expand its therapeutic portfolio.
The HERIZON‑GEA‑01 trial remains ongoing, with a second overall‑survival interim analysis scheduled for mid‑2026. Ziihera already holds accelerated approval for previously treated, unresectable or metastatic HER2‑positive biliary tract cancer, and the new data expand its therapeutic reach. The combination of robust clinical evidence, strategic partnerships, and a strong financial foundation positions Zymeworks and Jazz to pursue regulatory approval and market adoption in the coming months.
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