Ziihera sales for bile duct cancer reach $15 million in second quarter
Key Facts
U.S. approval of Ziihera for bile duct cancer is not a new regulatory development in 2026; the Food and Drug Administration granted the drug accelerated approval for this use on November 20, 2024. The approval covers adults with HER2-positive, IHC 3+ biliary tract cancer after prior treatment, when the disease is unresectable or metastatic. The available facts therefore correct the timing of the approval in the earlier draft, which presented it as a new event. In the second quarter of 2026, net sales of the drug for this use reached $15 million, according to Jazz Pharmaceuticals’ summary. That figure puts the product’s commercial performance at the center of the news, rather than presenting the old approval again as a new stock catalyst.
The company’s detailed financial table shows sales of $15.4 million in the second quarter of 2026, compared with $6 million in the corresponding quarter of 2025. The company’s financial summary rounds the figure to $15 million for the same period, so the two figures differ in level of detail, not in the period they cover. The year-over-year comparison provides context for the sales recorded, without by itself establishing the reasons for the change. When the U.S. approval was announced, Jazz said the HERIZON-BTC-01 trial recorded an objective response rate of 52%. It added that the median duration of response was 14.9 months, according to an independent central review.
The accelerated U.S. approval remains subject to requirements to verify clinical benefit and describe it in a confirmatory trial, according to Jazz. The company said continued approval for this use may depend on confirmation of that benefit in the Phase 3 HERIZON-BTC-302 trial. The trial compares the combination treatment with first-line standard of care and is ongoing, according to the company’s announcement. For another use of the drug, Jazz announced on August 25, 2026, that the FDA had approved two regimens containing Ziihera for first-line treatment of advanced HER2-positive gastroesophageal adenocarcinoma. CEO Renée Gala also said the company is preparing to launch Ziihera for this use, alongside progress in its clinical programs and expansion of its development pipeline.
In results from the HERIZON-GEA-01 study published on October 23, 2026, median overall survival was 22.9 months with Ziihera and chemotherapy, compared with 19.6 months with trastuzumab and chemotherapy. The company said the combination of Ziihera and chemotherapy reduced the risk of death by 24% compared with the other regimen. These results concern gastroesophageal adenocarcinoma, not the drug’s use in bile duct cancer, for which U.S. approval dates to 2024. Jazz Pharmaceuticals shares closed at $214 on October 23, 2026, according to data provided by EL7. The company said on October 19 that it would report third-quarter results on November 2, 2026, after U.S. markets close, with an investor webcast at 4:30 p.m. Eastern Time.