Jazz Pharmaceuticals (JAZZ) catalysts

Upcoming FDA decisions and readouts we track for Jazz Pharmaceuticals, each with the filing that announced it.

Listed on — Nasdaq Catalysts tracked — 1 Rows last checked — 14 Sep 2026

FreeBioList has 1 catalyst on record for Jazz Pharmaceuticals (JAZZ, listed on Nasdaq), all now decided. It concerns Zanidatamab (Ziihera) (HER2-positive first-line gastroesophageal adenocarcinoma).

Decided and on record:

Zanidatamab (Ziihera), PDUFA date: Approved 25 August 2026, on the PDUFA date.

Each outcome links to the filing or notice that reported it in the table below.

The row links to an SEC filing (8-K or 6-K). It has been verified by a person reading the filing itself, most recently on 14 Sep 2026. The methodology page explains each status.

Background reading: What a PDUFA date is, and why the FDA doesn't publish them.

Ticker: JAZZ
Next catalyst: —
Type: —
Listed options: Yes

Company ▾	Drug ▾	Effect / indication	Next catalyst ▾	Phase / type ▾	Status ▾	Source	Options
Jazz Pharmaceuticals JAZZ · Nasdaq	Zanidatamab (Ziihera)	HER2-positive first-line gastroesophageal adenocarcinoma	25 Aug 2026 43d ago	PDUFA date	Verified	8-K ↗	Yes
Notes — Filing states the FDA "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)." Outcome — Approved 25 August 2026, on the PDUFA date — FDA approved two Ziihera (zanidatamab-hrii) regimens (with and without Tevimbra/tislelizumab, plus chemotherapy) for first-line HER2-positive gastroesophageal adenocarcinoma. Source: 8-K, filed 25 Aug 2026 · verified 14 Sep 2026

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