Zymeworks Inc. (ZYME) saw its shares surge by 5.05% on November 4, 2024, as investors anticipated two major upcoming catalysts for the company's lead drug candidate, Zanidatamab.
First, the U.S. Food and Drug Administration (FDA) has set a PDUFA date of November 29, 2024, for the potential approval of Zanidatamab in the treatment of patients with second-line biliary tract cancer. The drug has been granted Priority Review, indicating the FDA's recognition of its potential to address an unmet medical need.
Secondly, Zymeworks and its partners, Jazz Pharmaceuticals and BeiGene, are expecting to release progression-free survival data from the phase 3 HERIZON-GEA-01 study in the second quarter of 2025. This study is evaluating Zanidatamab in combination with chemotherapy, with or without the addition of tislelizumab, for the treatment of patients with first-line locally advanced or metastatic gastroesophageal adenocarcinoma (GEA).
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