On August 25, 2026, Zymeworks issued a press release announcing that its partner Jazz Pharmaceuticals received U.S. FDA approval for two treatment regimens containing Ziihera® (zanidatamab-hrii) as first-line therapy for adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma (GEA). One regimen pairs Ziihera with Tevimbra® plus fluoropyrimidine- and platinum-based chemotherapy for patients whose tumors are HER2 IHC 3+ or IHC 2+/ISH+, while the other combines Ziihera with chemotherapy alone for the HER2 IHC 3+ subgroup. The news was disclosed under Regulation FD (Item 7.01), with the press release furnished as Exhibit 99.1.
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