---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-262940"
form_type: "8-K"
ticker: "JAZZ"
cik: "0001232524"
company_name: "Jazz Pharmaceuticals plc"
filed_at: "2024-11-21T23:59:59+00:00"
generated_at: "2026-05-29T20:25:11.640347+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Jazz Pharmaceuticals receives FDA accelerated approval for Ziihera in HER2+ biliary tract cancer

## Summary
- FDA approved Ziihera (zanidatamab-hrii) for adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) BTC.
- Approval based on 52% objective response rate and median duration of response of 14.9 months by independent central review.
- First and only dual HER2-targeted bispecific antibody approved for this indication in the U.S.
- Continued approval contingent on confirmatory Phase 3 trial HERIZON-BTC-302; Boxed Warning for embryo-fetal toxicity.
- Investor webcast scheduled for December 11, 2024, to discuss clinical data and commercialization strategy.

## SEC filing metadata
- accession: 0001193125-24-262940
- form_type: 8-K
- ticker: JAZZ
- cik: 0001232524
- company_name: Jazz Pharmaceuticals plc
- filed_at: 2024-11-21T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1232524/000119312524262940/0001193125-24-262940-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1232524/000119312524262940/d832756d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-262940
- JSON: https://secwatch.observer/filing/0001193125-24-262940.json
- Plain text: https://secwatch.observer/filing/0001193125-24-262940.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.