Zymeworks Inc.’s cancer drug zanidatamab (Ziihera) received FDA approval for treating biliary-tract cancer, marking a milestone in the company’s recovery. The drug is the first bispecific antibody and chemotherapy-free treatment for metastatic HER2-positive BTC. Zymeworks, which faced a corporate crisis in 2022, has partnered with Jazz Pharmaceuticals for North America, Europe, and Japan, and with BeiGene Ltd. for other Asian markets. The approval unlocks potential peak global sales of US$55-million, with further trials potentially expanding this to US$750-million. Zymeworks is eligible for up to US$500-million in milestone payments from Jazz and royalties of 10-20% on net sales.