Jazz Pharmaceuticals Announces FDA Acceptance and Priority Review of Supplemental Biologics License Application for Ziihera® (zanidatamab-hrii) Combinations in First-Line HER2+ Locally Adv...
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
DUBLIN April 27, 2026 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review the supplemental Biologics License Application (sBLA) for Ziihera ® (zanidatamab-hrii) containing combinations for the first-line treatment of adult patients with HER2-positive (HER2+) unresectable locally advanced or metastatic gastric, gastroesophageal junction (GEJ), or gastroesophageal adenocarcinoma (GEA). The FDA has set a PDUFA target action date of August 25, 2026. The sBLA is supported by data from the pivotal HERIZON-GEA-01 trial to investigate the efficacy and safety of zanidatamab in combination with standard-of-care chemotherapy with or without the PD-1 inhibitor Tevimbra ® (tislelizumab) in patients with advanced or metastatic GEA, including gastric, GEJ and esophageal adenocarcinomas. The submission is under review via the Real-Time Oncology Review (RTOR) program, an initiative of FDA's
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News
- How ASCO Phase 3 Oncology Data May Reshape Jazz Pharmaceuticals' (JAZZ) Investment Narrative [Yahoo! Finance]Yahoo! Finance
- Unpacking Q4 Earnings: Jazz Pharmaceuticals (NASDAQ:JAZZ) In The Context Of Other Pharmaceuticals Stocks [Yahoo! Finance]Yahoo! Finance
- Jazz Pharmaceuticals Scores FDA Priority Review for Ziihera Combinations in First-Line HER2+ Gastroesophageal Cancer [TheStreet.com]TheStreet.com
- Jazz Pharmaceuticals Announces FDA Acceptance and Priority Review of Supplemental Biologics License Application for Ziihera® (zanidatamab-hrii) Combinations in First-Line HER2+ Locally Advanced or Metastatic GEAPR Newswire
- Barclays Raises its Price Target on Jazz Pharmaceuticals (JAZZ) to $225 [Yahoo! Finance]Yahoo! Finance
JAZZ
Earnings
- 2/24/26 - Beat
JAZZ
Sec Filings
- 4/24/26 - Form 10-K/A
- 4/3/26 - Form 4
- 4/1/26 - Form 144
- JAZZ's page on the SEC website