Shares of NovoCure Ltd. surged in premarket activity on Thursday, February 12, 2026, following a significant regulatory milestone. The stock was indicated approximately 23% higher, trading around $12.91, after the company announced that the U.S. Food and Drug Administration (FDA) granted approval for its Optune Pax device as a treatment for locally advanced pancreatic cancer.
A Major Expansion for Tumor Treating Fields
This approval represents a crucial expansion for NovoCure's core Tumor Treating Fields (TTFields) technology platform. The therapy utilizes low-intensity, alternating electric fields to disrupt the division of cancer cells. With this decision, the company secures its first U.S. product label outside its established franchises in glioblastoma and mesothelioma, moving into a notoriously difficult-to-treat cancer type.
NovoCure emphasized the historic nature of the approval, stating that Optune Pax is the first FDA-cleared treatment for locally advanced pancreatic cancer in nearly three decades. This is particularly impactful given the disease's aggressive nature and the limited options for patients who are often ineligible for surgical intervention. Dr. Vincent Picozzi, a trial investigator, noted in the company's statement that the approval has "the potential to be practice changing."
Clinical Trial Data and Market Implications
The regulatory green light was supported by data from the Phase 3 PANOVA-3 clinical study. According to NovoCure, patients receiving Optune Pax in combination with standard chemotherapy drugs gemcitabine and nab-paclitaxel demonstrated a median overall survival of 16.2 months. This compared to 14.2 months for those receiving chemotherapy alone. The company also reported a meaningful extension in median time to pain progression—15.2 months versus 9.1 months—with progression defined by a patient-reported increase in pain score or death.
Frank Leonard, NovoCure's Chief Executive Officer, characterized the approval as marking "the first new treatment in decades" for this patient population. He described Optune Pax as a "fundamentally different treatment" due to its biophysical mechanism of action, which is distinct from pharmacological approaches. The FDA's decision was formally disclosed in a corporate 8-K filing submitted late on Wednesday, February 11th.
Despite the enthusiastic premarket reaction, which saw shares rise as much as 34% earlier in the session according to market data from Investing.com, analysts note potential headwinds. Investors are likely to scrutinize the commercial uptake speed for a wearable device in a treatment landscape dominated by systemic chemotherapy. Key considerations include securing insurance coverage and reimbursement from payers, which will be critical for widespread adoption. Furthermore, the company acknowledged that most patients treated with Optune Pax experienced expected device-related skin reactions under the electrode arrays, in addition to known chemotherapy side effects.
The company's near-term focus will shift to the commercial rollout. NovoCure is scheduled to host its fourth-quarter earnings conference call on February 26, 2026, where management will undoubtedly face detailed questioning from investors regarding the U.S. launch strategy and the potential financial impact of the pancreatic cancer label on the company's 2026 outlook.
This development underscores the ongoing innovation in oncology therapeutics and highlights the market's valuation of successful regulatory pathways for novel treatment modalities. The substantial premarket move reflects both the unmet medical need in pancreatic cancer and the significant commercial opportunity this approval unlocks for NovoCure.