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BCS

Current Report · Items 8.01 · 8-K

Jazz Pharmaceuticals plc

JAZZNASDAQEQUITYCurrent

Other Events

Item 8.01. Other Events. On August 25, 2026, Jazz Pharmaceuticals plc (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration approved two Ziihera® (zanidatamab-hrii)-containing regimens for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive (HER2+) gastroesophageal adenocarcinoma (GEA):…

Filed Aug 25, 2026Accepted Aug 25, 2026, 4:06 PM EDTCIK 1232524Accession 0001628280-26-058864
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Company context

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with rare diseases - often with limited or no therapeutic options. We have a diverse portfolio of medicines, including leading therapies addressing epilepsies, cancers and sleep disorders. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide.

Current securities

Recent company filings

  1. Results of Operations and Financial ConditionOct 26, 2026
  2. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory ArrangementsOct 9, 2026
  3. 4 filingOct 5, 2026
  4. 144 filingOct 1, 2026
  5. Entry into a Material Definitive Agreement · Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet ArrangementSep 23, 2026

Registered securities in this filing

Jazz Pharmaceuticals plc · 8-K · Filed 2026-08-25

As filed in this accession. Current/historical status below comes from the governed listing record; the cover itself remains exact to this filing.

Ordinary shares, nominal value $0.0001 per share

Symbol
JAZZ
Exchange
NASDAQ
Classification
COMMON
Status
Current
Filing context

Context: c-1

Dimensions: Not supplied

Accession 000162828026058864 · 1 registered-security cover member

Read the exact SEC filing ↗

Disclosure sections

Items 8.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

Item 8.01Item 8.01 - Other Events
Item 8.01. Other Events. On August 25, 2026, Jazz Pharmaceuticals plc (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration approved two Ziihera® (zanidatamab-hrii)-containing regimens for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive (HER2+) gastroesophageal adenocarcinoma (GEA): Ziihera plus Tevimbra® (tislelizumab-jsgr) and chemotherapy (HER2+ IHC 3+ or IHC 2+/ISH+), and Ziihera plus chemotherapy (HER2+ IHC 3+). A copy of the press release is filed herewith as Exhibit 99.1 and incorporated herein by reference.

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