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+) Bilia...
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
Ziihera received accelerated approval based on results including a 52% objective response rate and median duration of response of 14.9 months as determined by independent central review (ICR) from the HERIZON-BTC-01 clinical trial Company to host investor webcast on Dec. 11, 2024 For U.S. media and investors only DUBLIN Nov. 20, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) accelerated approval of Ziihera ® (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test. Ziihera was approved under accelerated approval based on a 52% objective response rate (ORR) and a median duration of response (DOR) of 14.9 months as determined by independent central review (ICR). Continued approval for this indication may be contingent upon verification and
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News
- JAZZ Secures FDA Approval for Ziihera in Biliary Tract Cancer [Yahoo! Finance]Yahoo! Finance
- 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)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