Jazz Pharmaceuticals Scores FDA Priority Review for Ziihera Combinations in First-Line HER2+ Gastroesophageal Cancer [TheStreet.com]
Jazz Pharmaceuticals plc - Ordinary Shares (JAZZ)
Last jazz pharmaceuticals plc - ordinary shares earnings: 2/25 04:05 pm
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Source: TheStreet.com
FDA accepted and granted Priority Review to its supplemental Biologics License Application (sBLA) for Ziihera® (zanidatamab-hrii) combinations in first-line HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). The agency has set a PDUFA target action date of August 25, 2026 The sBLA draws on data from the pivotal HERIZON-GEA-01 trial, which examined zanidatamab paired with standard-of-care chemotherapy — with or without the PD-1 inhibitor Tevimbra® (tislelizumab) — in patients with advanced or metastatic GEA. Notably, the FDA is reviewing the submission through its Real-Time Oncology Review (RTOR) program, an initiative designed to fast-track access to safe and effective cancer treatments. “The HERIZON-GEA-01 trial results are practice changing,” said Rob Iannone, M.D., Executive Vice President and Chief Medical Officer at Jazz Pharmaceuticals. He highlighted that adding tislelizumab to zanidatamab plus chemotherapy further boosted clinical benefit —
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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 Announces FDA Acceptance and Priority Review of Supplemental Biologics License Application for Ziihera® (zanidatamab-hrii) Combinations in First-Line HER2+ Locally Advanced or Metastatic GEA [Yahoo! Finance]Yahoo! Finance
- 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