Jazz Pharmaceuticals’ Ziihera Receives Conditional European Approval for Advanced Biliary Tract Cancer

Jazz Pharmaceuticals (NASDAQ:JAZZ) is one of the best high short interest stocks with huge upside potential. On July 2, Jazz Pharmaceuticals announced that the European Commission/EC had granted conditional marketing authorization for its new bispecific antibody, called Ziihera (zanidatamab), for the treatment of biliary tract cancer/BTC.

The approval extends to all European Union member states, as well as Norway, Iceland, and Liechtenstein. Ziihera is authorized as a single agent for adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+) BTC who have previously received at least one line of systemic therapy. The recommended dose for zanidatamab is 20mg/kg, administered intravenously every two weeks, until disease progression or unacceptable toxicity.

Jazz Pharmaceuticals' Ziihera Receives Conditional European Approval for Advanced Biliary Tract Cancer

A biopharmaceutical scientist in their lab, studying a newly-diagnosed therapy-related acute myeloid leukemia. .

The EC’s decision was supported by data from the Phase IIb HERIZON-BTC-01 trial, which included 87 participants with previously treated, locally advanced or metastatic HER2-positive BTC. The continuation of this conditional approval depends on further clinical benefits being demonstrated in the ongoing Phase III HERIZON-BTC-302 trial.

Jazz Pharmaceuticals (NASDAQ:JAZZ) identifies, develops, and commercializes pharmaceutical products in the US, Europe, and internationally.

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Disclosure: None. This article is originally published at Insider Monkey.