Zymeworks

Zymeworks and Jazz Pharmaceuticals announce FDA accelerated approval of Ziihera 50mg/mL for HER2-positive biliary tract cancer, with a 52% response rate and 14.9-month median duration. Zymeworks earned $25M milestone and may receive up to $1.362B more in payments and royalties.

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.

Jazz Pharmaceuticals' Ziihera (zanidatamab-hrii) received FDA accelerated approval for treating HER2-positive biliary tract cancer (BTC), showing a 52% response rate and 14.9 months median response duration. This marks a significant advancement for BTC patients, offering a chemotherapy-free, dual HER2-targeted treatment. Continued approval depends on confirmatory trial results.

FDA grants accelerated approval to Zymeworks' Ziihera for bilary tract cancer, triggering $25M milestone payment from Jazz Pharmaceuticals. Zymeworks could earn over $1B in milestone payments and royalties. Ziihera is a bispecific antibody variant of Zanidatamab, developed for various cancers.

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The FDA approved zanidatamab-hrii (Ziihera) for previously treated, unresectable or metastatic HER2-positive biliary tract cancer, based on a 52% objective response rate. Manufactured by Zymeworks Inc. and Jazz Pharmaceuticals, zanidatamab showed antitumor activity in the HERIZON-BTC-01 trial. Common adverse reactions included diarrhea, infusion-related reaction, abdominal pain, and fatigue.

Zymeworks Inc. announces participation in upcoming investor conferences and Research & Development Day, featuring updates on preclinical programs and therapeutic platform expansions.

Ziihera, a dual HER2-targeted bispecific antibody, received accelerated FDA approval for HER2-positive biliary tract cancer (BTC) with a 52% objective response rate and median duration of response of 14.9 months. Zymeworks is eligible for up to $500M in regulatory milestones and $862.5M in commercial milestones. Regulatory reviews for zanidatamab are ongoing in China and Europe. The approval validates Zymeworks' Azymetric™ technology and capabilities in novel medicine development. Zanidatamab is also being investigated in Phase 3 trials for gastroesophageal adenocarcinomas and metastatic breast cancer.