JAZZ Secures FDA Approval for Ziihera in Biliary Tract Cancer [Yahoo! Finance]
Jazz Pharmaceuticals plc - Ordinary Shares (JAZZ)
Last jazz pharmaceuticals plc - ordinary shares earnings: 2/25 04:05 pm
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Source: Yahoo! Finance
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. Year to date, shares of Jazz have lost 3.0% compared with the industry's 10.9% decline. Image Source: Zacks Investment Research Jazz is conducting the phase III HERIZON-BTC-302 study on Ziihera combined with standard-of-care (SoC) therapy in the f
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News
- Jazz Pharmaceuticals plc (NASDAQ: JAZZ) had its "buy" rating re-affirmed by analysts at Needham & Company LLC. They now have a $207.00 price target on the stock.MarketBeat
- Jazz Pharmaceuticals plc (NASDAQ: JAZZ) had its "overweight" rating re-affirmed by analysts at Piper Sandler. They now have a $163.00 price target on the stock, down previously from $166.00.MarketBeat
- FDA Grants U.S. Approval of Ziihera® (zanidatamab-hrii) for the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC) [Yahoo! Finance]Yahoo! Finance
- Jazz Pharmaceuticals Announces U.S. FDA Approval of Ziihera® (zanidatamab-hrii) for the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC) [Yahoo! Finance]Yahoo! Finance
- Jazz Pharmaceuticals Announces U.S. FDA Approval of Ziihera® (zanidatamab-hrii) for the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)PR Newswire
JAZZ
Earnings
- 11/6/24 - Beat
JAZZ
Sec Filings
- 11/21/24 - Form 8-K
- 11/13/24 - Form 4
- 11/12/24 - Form SC
- JAZZ's page on the SEC website