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 Ltd’s Chief Operating Officer, Paravasthu Mukund, reported an automatic share withholding related to equity compensation. On 01/11/2026, 2,133 ordinary shares were withheld by the company at a price of $14.35 per share to cover tax obligations arising from the vesting of Restricted Stock Units.
After this non-discretionary tax-withholding transaction, Mukund beneficially owns 78,306 ordinary shares directly. The withholding was approved as required under Rules 16b-3(e) and 16b-3(d)(1), and reflects routine tax handling of vested stock-based awards rather than an open-market sale.
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 Ltd. (NVCR) reported an insider transaction on Form 4 for its Chief Financial Officer. On 11/04/2025, 7,033 ordinary shares were withheld at $12.23 to satisfy tax obligations from the vesting of Restricted Stock Units. Following this withholding (transaction code F), the CFO directly holds 134,117 shares. The filing notes the action was not discretionary and was approved pursuant to Rules 16b-3(e) and 16b-3(d)(1).
NovoCure Ltd. (NVCR) reported insider activity by Chief Operating Officer Mukund Paravasthu related to RSU vesting tax withholding. On 11/01/2025, the issuer withheld 168 ordinary shares at $12.81 per share. On 11/04/2025, the issuer withheld an additional 2,949 ordinary shares at $12.23 per share. These are coded “F” transactions, reflecting shares withheld to satisfy tax obligations and described as non-discretionary. Following these transactions, Paravasthu directly beneficially owned 80,439 ordinary shares.
NovoCure Ltd (NVCR) reported an insider transaction on a Form 4. The company’s officer, EVP, President, Novocure Oncology, had 966 ordinary shares withheld on 11/01/2025 at $12.81 per share to satisfy tax obligations upon the vesting of Restricted Stock Units (transaction code F).
Following this non-discretionary withholding, the officer beneficially owns 347,745 shares, held directly. The filing indicates it was made by one reporting person.
NovoCure Ltd (NVCR): The company’s Chief Human Resources Officer reported a tax withholding transaction tied to RSU vesting. On 10/31/2025, 752 ordinary shares were withheld under Transaction Code F at $12.82 per share to satisfy withholding obligations. Following the transaction, the officer beneficially owns 163,762 shares, held directly. The filing notes the action was non‑discretionary and approved pursuant to Rules 16b‑3(e) and 16b‑3(d)(1).
NovoCure Limited (NVCR) reported third-quarter 2025 results showing continued top-line growth alongside operating losses. Net revenues were $167,204 (thousands), up 8% year over year, driven by growth in France, Germany and other international markets, partially offset by lower U.S. prior-period claim benefits and $3,300 of FX tailwinds. Gross margin was 73% versus 77% a year ago, reflecting higher array costs, tariffs, and a $2,900 inventory obsolescence charge for Optune Lua arrays.
The company recorded a net loss of $37,270 (thousands) and operating loss of $36,021 (thousands). Cash and cash equivalents were $342,119 with short-term investments of $691,382 as of September 30, 2025. NovoCure drew the Tranche B term loan, bringing its senior secured credit facility borrowings to $200,000, and its 0% Convertible Senior Notes due 2025 carried a current liability of $560,620.
Commercial metrics improved: active patients rose to 4,416 from 4,113, and total prescriptions increased to 1,805 from 1,586. Management highlighted clinical and regulatory milestones, including PANOVA-3 results and ongoing PMA filings for pancreatic cancer (Optune Pax) and brain metastases from NSCLC (Optune Mya), while noting a potential impact from a U.S. government shutdown on FDA and reimbursement timelines.
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.