Jazz Pharmaceuticals JAZZ announced that the FDA has granted accelerated approval to its intravenously administered drug zanidatamab for certain patients with biliary tract cancer (BTC). The drug will be marketed under the trade name Ziihera.
With this nod, Ziihera gets approved for use in previously treated adult patients with unresectable or metastatic HER2-positive BTC. The approval also makes this drug the first dual HER2-targeted bispecific antibody and chemotherapy-free therapy for treating BTC in the country.
The commercial launch of the drug is expected before this year’s end.
The FDA’s approval is based on data from the phase IIb HERIZON-BTC-01 study on zanidatamab in the above indication. The study achieved its primary endpoint — patients who were treated with the drug achieved an objective response rate of 52%, with a median duration of response of 14.9 months.
JAZZ Stock Performance
Year to date, shares of Jazz have lost 3.0% compared with the industry’s 10.9% decline.
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JAZZ’s Progress With Ziihera Development
Jazz is conducting the phase III HERIZON-BTC-302 study on Ziihera combined with standard-of-care (SoC) therapy in the first-line setting for patients with HER2-positive BTC compared with SoC alone. This study will also be used to convert the accelerated approval to a full one.
Apart from BTC, Jazz is also developing the drug in two late-stage studies in gastroesophageal adenocarcinoma (GEA) and metastatic breast cancer indications. Top-line data from the GEA study are expected in the second quarter of 2025. Management is also evaluating Ziihera in the phase II DiscovHER-Pan-206 pan-tumor study in HER2-positive solid tumors.
Jazz acquired exclusive rights to develop and market across Ziihera in all territories except Asia/Pacific (where the drug has been licensed to BeiGene) from Zymeworks in 2022.
JAZZ’s Zacks Rank
JAZZ currently carries a Zacks Rank #3 (Hold).
Jazz Pharmaceuticals PLC Price
Jazz Pharmaceuticals PLC price | Jazz Pharmaceuticals PLC Quote
Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are Castle Biosciences CSTL, CytomX Therapeutics CTMX and Spero Therapeutics SPRO, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. During the same timeframe, loss per share estimates for 2025 have narrowed from $2.13 to $1.88. Year to date, shares of Castle Biosciences have surged 33.8%.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.
In the past 60 days, estimates for CytomX Therapeutics’ 2024 loss per share have narrowed from 29 cents to 13 cents. Estimates for 2025 loss per share have narrowed from 56 cents to 46 cents. Year to date, shares of CytomX Therapeutics have lost 42.4%.
CytomX Therapeutics’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average surprise of 115.70%.
In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.31. Estimates for 2025 loss per share have narrowed from $1.54 to $1.16. Year to date, shares of Spero Therapeutics have lost 21.1%.
Spero Therapeutics’ earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 94.42%.
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