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)
Zymeworks Inc. (ZYME)
Last zymeworks inc. earnings: 3/2 04:15 pm
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Source: GlobeNewswire
Ziihera is the first and only dual HER2-targeted bispecific antibody approved for HER2-positive BTC in the U.S.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$25M milestone payment to be received from Jazz Pharmaceuticals in relation to the FDA approval; Zymeworks remains eligible for up to $500M in regulatory milestonesRegulatory reviews of zanidatamab for BTC remain ongoing in China and EuropeU.S. FDA approval of zanidatamab provides validation of the Company’s proprietary Azymetric™ technology and capabilities for design and development of novel medicinesZanidatamab continues to be investigated in a number of additional tumor types, including Phase 3 trials in gastroesophageal adenocarcinomas (GEA) and metastatic breast cancer (mBC) VANCOUVER, British Columbia, Nov. 21, 2024 (GLOBE NEWSWIRE) -- Zyme
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News
- FDA Approves Ziihera for HER2-Positive Biliary Tract Cancer [Yahoo! Finance]Yahoo! Finance
- Zymeworks Announces Participation in Upcoming Investor Conferences [Yahoo! Finance]Yahoo! Finance
- Zymeworks Announces Participation in Upcoming Investor ConferencesGlobeNewswire
- Zymeworks Inc. (NYSE: ZYME) was upgraded by analysts at Leerink Partners from a "market perform" rating to an "outperform" rating. They now have a $25.00 price target on the stock, up previously from $10.00.MarketBeat
- Zymeworks Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating ZW191 in Folate Receptor-? Expressing Advanced Solid TumorsGlobeNewswire
ZYME
Earnings
- 10/31/24 - Beat
ZYME
Sec Filings
- 11/21/24 - Form 8-K
- 11/14/24 - Form SC
- 11/14/24 - Form SC
- ZYME's page on the SEC website