Zanidatamab

David Martin PhD maintains Buy rating on Zymeworks (ZYME) with $19.50 target, citing FDA approval for zanidatamab and ongoing Phase 3 trial. Leerink Partners also maintains Buy rating with $26.00 target.

Zanidatamab (ZW25) demonstrated a confirmed objective response rate (cORR) of 41.3% and a disease control rate (DCR) of 68.8% in pretreated, advanced HER2+ biliary tract cancer patients, with a median duration of response of 14.9 months and median overall survival (OS) of 15.5 months. The safety profile remained consistent, with no new safety signals observed.

The FDA granted accelerated approval to zanidatamab for previously treated, unresectable or metastatic HER2-positive biliary tract cancer, based on a 52% overall response rate in the HERIZON-BTC-01 trial. Common adverse effects included diarrhea, infusion-related reaction, abdominal pain, and fatigue. The ongoing HERIZON-BTC-302 trial will confirm efficacy in the frontline setting.

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FDA approves Zihera, a non-chemotherapy treatment for metastatic HER2-positive biliary tract cancer, developed by Zymeworks. Jazz Pharmaceuticals secured commercialization rights for $375 million USD upfront, with additional royalties. Zihera showed significant tumor shrinkage in a Phase 2b trial, with benefits lasting an average of 15 months.

The FDA approved zanidatamab (Ziihera) for advanced HER2-positive biliary tract cancer, targeting HER2 at two sites to halt tumor growth and aid immune response. A companion diagnostic, Ventana Pathway anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody, was also approved. In a trial, 52% of patients saw tumor shrinkage for about 15 months. Ziihera carries a warning about potential harm to unborn babies and common side effects include diarrhea, infusion-related reactions, stomachache, and tiredness. Jazz Pharmaceuticals is testing Ziihera with standard therapy against standard therapy alone for first-line treatment.

FDA grants accelerated approval to zanidatamab for pretreated HER2-positive biliary tract cancer, with HER2 positivity defined as IHC score of 3+. HERIZON-BTC-01 trial showed 52% response rate, 14.9 months duration of response. Ongoing phase III trial HERIZON-BTC-302 to confirm benefit. Common AEs include diarrhea, infusion-related reactions, abdominal pain, and fatigue.

The FDA granted accelerated approval to Zymeworks Inc.'s Ziihera for treating biliary tract cancer, triggering a $25M milestone payment from Jazz Pharmaceuticals. Zymeworks could earn over $1B in milestone payments and royalties. Ziihera is a variation of Zanidatamab, developed for various cancers, and marks Zymeworks' first FDA-approved therapy.

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.