NovoCure Limited filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits
$NVCR
Medical/Dental Instruments
Health Care
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
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Item 7.01 Regulation FD Disclosure.
On April 22, 2025 , the Company issued a press release announcing that that that Optune Lua® has received a CE (Conformité Européenne) Mark for the treatment of adult patients with metastatic non-small cell lung cancer (mNSCLC) concurrently with immune checkpoint inhibitors or docetaxel who have progressed on or after a platinum-based regimen. As a condition to receiving the CE mark, Novocure will conduct a post-market study of TTFields concomitant with docetaxel in patients with NSCLC to assess overall survival in the routine care setting. Novocure has initiated the local registration requirements for Optune Lua in Germany and is preparing for launch in the coming weeks.
The information contained in this Current Report shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
| Exhibit No. | Description | ||||
| 99.1 | |||||
| 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.
NovoCure Limited
(Registrant)
Date: April 22, 2025
By: /s/ Christoph Brackmann
Name: Christoph Brackmann
Title: Chief Financial Officer