SEC Form 8-K filed by Jazz Pharmaceuticals plc
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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CURRENT REPORT
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| Item 8.01. | Other Events. |
On November 20, 2024, Jazz Pharmaceuticals plc (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) accelerated approval of Ziihera®(zanidatamab-hrii) 50mg/mL for injection for IV for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test. FDA granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
A copy of the press release is filed herewith as Exhibit 99.1 and incorporated herein by reference.
| Item 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits |
| Exhibit Number |
Description | |
| 99.1 | Press Release dated November 20, 2024. | |
| 104 | 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| JAZZ PHARMACEUTICALS PUBLIC LIMITED COMPANY | ||
| By: | /s/ Neena Patil | |
| Name: | Neena Patil | |
| Title: | Executive Vice President and Chief Legal Officer | |
Date: November 21, 2024