secwatch / observer

8-K filed November 21, 2024, 6:59 PM ET ticker JAZZ CIK 0001232524

regulatory confidence high sentiment positive materiality 0.85

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

Jazz Pharmaceuticals plc

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.

item 8.01 item 9.01

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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
discovered_at: 2026-05-14T18:03:07.905083+00:00
generated_at: 2026-05-29T20:25:11.640347+00:00
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event_type: regulatory
sentiment: positive
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confidence: high
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