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
- Zymeworks Inc. (NYSE: ZYME) had its price target raised by analysts at Wells Fargo & Company from $12.00 to $14.00. They now have an "equal weight" rating on the stock.MarketBeat
- Zymeworks Inc. (NYSE: ZYME) was upgraded by analysts at JPMorgan Chase & Co. from a "neutral" rating to an "overweight" rating. They now have a $18.00 price target on the stock.MarketBeat
- Zymeworks Hosts R&D Day Highlighting Continued Clinical Progress in Oncology Programs and Expansion into Autoimmune and Inflammatory Diseases [Yahoo! Finance]Yahoo! Finance
- Zymeworks Hosts R&D Day Highlighting Continued Clinical Progress in Oncology Programs and Expansion into Autoimmune and Inflammatory DiseasesGlobeNewswire
- Zymeworks Inc. (NYSE: ZYME) had its "neutral" rating re-affirmed by analysts at HC Wainwright. They now have a $12.00 price target on the stock.MarketBeat
ZYME
Earnings
- 10/31/24 - Beat
ZYME
Sec Filings
- 12/12/24 - Form 4
- 12/12/24 - Form 4
- 12/12/24 - Form 4
- ZYME's page on the SEC website