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NASDAQ: NVCR NovoCure Ltd 8-K

NovoCure receives CE Mark for Optune Pax in pancreatic cancer, enabling European launch

Filed June 30, 2026 · Period ending June 30, 2026 · ~1 min read

Key Changes

  • high

    Optune Pax received CE Mark approval for locally advanced pancreatic cancer in Europe, enabling commercial launch in Germany within weeks following February 2026 FDA approval in the U.S.

    Item 7.01 — Regulation FD Disclosure verify on EDGAR →
  • high

    Phase 3 PANOVA-3 trial met primary endpoint: patients using Optune Pax with chemotherapy achieved median survival of 16.2 months versus 14.2 months for chemotherapy alone (2-month improvement, HR 0.82, p=0.039).

    Exhibit 99.1 view on EDGAR →
  • medium

    Trial showed 6.1-month delay in pain progression (15.2 vs 9.1 months, HR 0.74, p=0.027), addressing a debilitating symptom in pancreatic cancer patients.

    Exhibit 99.1 view on EDGAR →

1 more material change behind this preview — plus the full narrative summary, section-by-section diffs against the prior filing, and verbatim quotes with EDGAR citations.

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Generated by AI · Jul 1, 2026 12:18 AM