Every 8-K that NovoCure Limited (NVCR) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow NVCR and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full NVCR filings page.
NovoCure Ltd (NVCR) reported that director Timothy Scannell has retired from its Board of Directors, and his board seat was formally vacated in accordance with the company’s Articles of Association effective September 2, 2026.
The company stated that Mr. Scannell’s retirement after five years of service did not result from any disagreement with NovoCure or its management.
NovoCure Ltd (NVCR) reported that in mid-August 2026 it detected unauthorized access to certain information systems at a subsidiary. NovoCure activated its cybersecurity response plan, implemented containment measures, began an internal investigation, and engaged independent cybersecurity forensic experts to review the exposed data.
The review to date found exposure of internal company patient ID numbers for over 1,400 U.S. patient records (without names or other identifying data), additional identifying patient data for fewer than 50 patients in the western U.S., and general contact information for healthcare providers and employees. NovoCure states there was no access to its medical treatment devices, operations were not compromised, and all systems remain fully functional. The company currently does not believe the cybersecurity incident will have a material impact or reasonably likely material impact on its financial condition or results of operations but continues to evaluate the situation and related notification obligations.
Novocure Limited reported second-quarter 2026 net revenues of $183.6 million, a 16% increase year-over-year, with gross margin rising to 78% from 74%. The quarter remained loss-making, with a net loss of $15.7 million or $0.13 per share, but Adjusted EBITDA turned positive at $10.8 million.
Total active patients on Tumor Treating Fields therapy reached 5,128 globally, including 4,636 on Optune Gio, 207 on Optune Lua and 285 on Optune Pax. Cash, cash equivalents and short-term investments totaled $440.6 million as of June 30, 2026, against total liabilities of $457.1 million.
The company received a CE Mark for Optune Pax for locally advanced pancreatic cancer, with Germany as the first launch market, and updated 2026 guidance to $710 million–$725 million in net revenue and $0–$15 million in Adjusted EBITDA. Anticipated Q4 2026 milestones include a U.S. FDA decision on a premarket approval application for brain metastases from non-small cell lung cancer and completion of enrollment in the Phase 3 KEYNOTE D58 glioblastoma trial.
Novocure reported that its wearable device Optune Pax, which delivers Tumor Treating Fields, has received a CE Mark to treat adult patients with locally advanced pancreatic cancer of exocrine origin when used with gemcitabine and nab-paclitaxel in line with guideline recommendations. The approval is backed by the Phase 3 PANOVA-3 trial, where patients in the intent-to-treat group receiving Optune Pax plus chemotherapy achieved a median overall survival of 16.2 months versus 14.2 months on chemotherapy alone, and a significant 6.1‑month extension in median time to pain progression. In the modified intent-to-treat group, median overall survival reached 18.3 months with Optune Pax versus 15.1 months on chemotherapy alone. Optune Pax was generally well-tolerated, with mainly mild to moderate skin events and no device-related deaths reported.
Novocure reported topline data from its Phase 3 TRIDENT trial in newly diagnosed glioblastoma. The study tested starting Tumor Treating Fields (TTFields) at the beginning of chemoradiation versus starting during the maintenance phase.
The trial did not show a statistically significant improvement in the primary endpoint of overall survival for early initiation. Median overall survival in the intent-to-treat group was 17.7 months in the Early Start Arm versus 17.5 months in the Maintenance Start Arm (HR 0.953; p=0.519). One-, two- and three-year survival rates were similar between arms.
TTFields therapy, including initiation with chemoradiation, was well-tolerated with no new safety signals, and device-related safety remained consistent with prior TTFields studies in glioblastoma. Results have been accepted for presentation at the ASTRO 2026 Annual Meeting.
NovoCure Limited held its annual general meeting of shareholders, where investors re-elected eleven directors to serve until the 2027 meeting. Shareholders representing 93,826,730 ordinary shares, or approximately 81.01% of shares entitled to vote, were present in person or by proxy.
They approved the ratification of Kost Forer Gabbay & Kasierer, a member of Ernst & Young Global, as auditor for the fiscal year ending December 31, 2026, and supported executive compensation in a non-binding advisory vote. Shareholders also approved the Company’s Amended and Restated 2024 Omnibus Incentive Plan following a closely split vote between shares cast for and against.
Novocure reported first-quarter 2026 net revenues of $174.1 million, up 12% year over year, driven mainly by growth in European Optune Gio patients and contributions from Optune Lua and the Zai Lab partnership in Greater China. Gross margin improved to 78% from 75% as array costs fell.
Higher operating expenses led to a wider net loss of $71.1 million, or $0.62 per share, largely due to a $43 million non-cash share-based compensation charge tied to U.S. FDA approval of Optune Pax. Adjusted EBITDA was slightly negative at $0.3 million.
The company ended March 31, 2026 with $432.0 million in cash, cash equivalents and short-term investments and 4,791 active TTFields patients globally. Regulatory and clinical momentum included U.S. FDA approval and U.S. launch of Optune Pax for locally advanced pancreatic cancer, new coverage decisions in Czechia, British Columbia and Japan, and positive Phase 2 PANOVA-4 data in metastatic pancreatic cancer. Novocure raised 2026 revenue guidance to $690–$710 million and tightened Adjusted EBITDA guidance to a range of $(15) million to breakeven.
NovoCure Limited filed an amendment to a prior report to describe the compensation package for its new Chief Executive Officer, Frank Leonard, whose appointment became effective December 1, 2025. A new employment agreement, effective January 1, 2026, sets an annual base salary of CHF 750,000 and a discretionary annual cash bonus targeted at 90% of base salary, based on performance goals set by the Board.
Leonard is eligible for equity awards under the 2024 Omnibus Incentive Plan and broad executive benefits, including relocation reimbursement from the U.S. to Switzerland and six months of COBRA reimbursements, each grossed up for taxes. He also receives tax indemnification if U.S. federal and Pennsylvania authorities do not fully credit Swiss tax payments. If terminated without cause or if he resigns for good reason before a change in control, he is entitled to one year of base salary paid in installments. If such a termination occurs within 12 months after a change in control, he is entitled to a lump sum of 200% of base salary plus 200% of target bonus, and all equity awards will fully vest. The agreement includes perpetual non-disparagement and 12‑month post-employment confidentiality, non-compete, and non-solicitation covenants.
NovoCure Limited reported a change to executive compensation as Uri Weinberg, M.D., Ph.D. takes on the additional role of Chief Medical Officer while continuing as Chief Innovation Officer. Under a letter agreement dated April 7, 2026, he will receive a stipend increasing his salary by CHF 5,000 per month for as long as he serves as Chief Medical Officer. The company states this additional amount is tied solely to the extra assignment and will not be included when calculating his annual incentive payment, while all other employment terms remain unchanged.
Novocure reported positive topline Phase 2 PANOVA-4 results for Tumor Treating Fields (TTFields) used with atezolizumab, gemcitabine and nab-paclitaxel as first-line therapy for metastatic pancreatic ductal adenocarcinoma.
The regimen achieved a disease control rate of 74.4% in 78 patients, compared with 48% in 431 patients receiving gemcitabine and nab-paclitaxel alone in a historical Phase 3 control, a 26.4% difference with strong statistical significance (1-sided p < 0.001). Objective response rate was 34.6% and median overall survival was 9.7 months. Treatment duration and safety for TTFields were consistent with prior studies, and the company plans to present additional data at a future scientific forum.
Novocure Limited reported modest growth in 2025 while advancing its cancer therapy portfolio. Full year net revenues reached $655.4 million, up 8%, with fourth quarter net revenues of $174.4 million, also up 8%, driven by more active patients on Tumor Treating Fields therapy.
Net loss improved to $136.2 million for 2025 and $24.5 million in the fourth quarter, with quarterly loss per share of $0.22. Adjusted EBITDA was $(16.4) million for the quarter and $(34.3) million for the year, reflecting high R&D and commercialization spending.
Novocure ended 2025 with $447.7 million in cash, cash equivalents and short-term investments and 4,620 active patients on therapy. In early 2026, the FDA approved Optune Pax for locally advanced pancreatic cancer, public payers in Czechia and British Columbia expanded Optune Gio coverage, and CMS reversed a temporary revocation of U.S. billing privileges. The company guided 2026 net revenues to $675–$705 million and Adjusted EBITDA between $(20) million and $0.
Novocure Limited reported that Medicare billing privileges for its U.S. subsidiary were temporarily revoked and then fully restored. CMS had revoked billing for the company’s products retroactive to December 17, 2025 due to an administrative issue with a triannual re-validation process, not a substantive qualification failure.
On February 24, 2026, CMS rescinded the revocation and reinstated Medicare billing privileges retroactive to December 17, 2025. Novocure states it continued serving existing and new patients throughout this period and believes there will ultimately be no impact on its ability to recognize revenue for those services.
Novocure Limited announced that the U.S. FDA approved Optune Pax, a wearable Tumor Treating Fields device, for adult patients with locally advanced pancreatic cancer when used with gemcitabine and nab-paclitaxel. This is described as the first FDA‑approved treatment in nearly 30 years for this disease stage.
In the Phase 3 PANOVA‑3 trial (571 patients), Optune Pax plus chemotherapy improved median overall survival to 16.2 months versus 14.2 months in the intent‑to‑treat group and to 18.3 months versus 15.1 months in the modified per protocol group, with statistically significant hazard ratios. One‑year survival rates and time to pain progression also improved, while safety was mainly limited to expected skin reactions under the arrays and fatigue, with no device‑related deaths or unanticipated safety issues.
Novocure Limited reported that its U.S. subsidiary’s Centers for Medicare & Medicaid Services (CMS) billing privileges were revoked retroactive to December 17, 2025 due to an administrative issue with triannual re-validation, not a substantive qualification failure. The company has filed a Corrective Action Plan and expects billing to be reinstated but cannot predict the timing or final outcome. During the suspension, Novocure continues treating existing and new patients but cannot bill Medicare, Medicare Advantage and other CMS-related programs, and estimates it cannot recognize approximately $13 million per month in revenue from these payors. The company intends to bill for services provided once privileges are restored but cannot estimate how much, if any, will ultimately be recoverable.
NovoCure Limited filed a current report to disclose that on January 12, 2026 it issued a press release with certain preliminary financial results and other information for the quarter and year ended December 31, 2025. The report explains that the figures in the press release are unaudited, preliminary, based on the company’s good faith estimates, and remain subject to completion of its financial closing procedures and final adjustments, so actual results may differ materially. The press release is furnished as Exhibit 99.1 and the company specifies that this information is being furnished under the securities laws rather than filed for liability purposes.
NovoCure Limited reported that it issued a press release announcing certain financial results for the quarter ended June 30, 2025. The announcement was furnished in an 8-K dated October 30, 2025.
The press release is provided as Exhibit 99.1.
NovoCure Limited filed a current report to highlight a regulatory milestone in Japan. On September 15, 2025, Japan’s Ministry of Health, Labour and Welfare approved NovoCure’s Optune Lua® device for use together with PD-1/PD-L1 inhibitor drugs to treat adult patients with unresectable advanced or recurrent non-small cell lung cancer whose disease has progressed after platinum-based chemotherapy. This expands Optune Lua’s approved treatment setting in Japan for a difficult-to-treat lung cancer population. The company released the news in a press release that is furnished as an exhibit to the report.
NovoCure Limited reported that its subsidiary Novocure GmbH has decided to terminate the LUNAR-4 clinical trial. LUNAR-4 is a phase 2, single-arm, open-label, multinational study evaluating Tumor Treating Fields used together with pembrolizumab for patients with metastatic non-small cell lung cancer who were previously treated with a PD-1/PD-L1 inhibitor and platinum-based chemotherapy.
The company explains that the availability of real-world evidence will allow it to achieve the trial’s objectives without continuing this interventional clinical study. NovoCure states that this decision is not related to any safety concerns.