NovoCure Ltd 8-K

What Happened

• On June 30, 2026 NovoCure Ltd announced via press release and filed a Form 8-K (Regulation FD disclosure) that Optune Pax® has received a CE (Conformité Européenne) Mark for the treatment of adult patients with locally‑advanced pancreatic cancer of exocrine origin. The intended use is concomitant with gemcitabine and nab‑paclitaxel (gem/nab‑pac) “in accordance with guideline recommendations.” The filing notes that because use of gem/nab‑pac may vary by market, the CE Mark language references guideline recommendations to reflect local differences. The press release is attached as Exhibit 99.1. The Form 8‑K was signed by CFO Christoph Brackmann.

Key Details

• Filing date: June 30, 2026 (Form 8‑K, Regulation FD Disclosure).
• Regulatory action: CE Mark granted for Optune Pax for adult locally‑advanced exocrine pancreatic cancer.
• Indication context: Use specified concomitant with gemcitabine + nab‑paclitaxel per guideline recommendations; wording accounts for market-by-market treatment differences.
• Filing attachments/signature: Press release included as Exhibit 99.1; Form signed by Chief Financial Officer Christoph Brackmann.
• Legal note in filing: Information is furnished under Item 7.01 and is not deemed “filed” for purposes of Section 18 of the Exchange Act unless expressly referenced.

Why It Matters

• The CE Mark permits NovoCure to market Optune Pax for the specified pancreatic cancer indication in CE‑mark jurisdictions (EU/EEA) under the stated intended use, which is a regulatory milestone described in the filing. The Form 8‑K does not include financial forecasts, commercialization plans, or quantified revenue impact; investors should monitor subsequent company disclosures for launch timing, reimbursement, market access, and sales updates.