New York, Feb 12, 2026, 05:40 EST — Premarket
- NovoCure shares surged about 23% ahead of the U.S. market open.
- The FDA cleared the company’s Optune Pax device for use in treating locally advanced pancreatic cancer.
- NovoCure’s Tumor Treating Fields therapy has received the green light for treating a different type of cancer.
NovoCure stock surged about 23% to $12.91 before the bell Thursday, following word that the FDA signed off on its Optune Pax device for locally advanced pancreatic cancer.
NovoCure has landed an updated U.S. product label, extending beyond its core Tumor Treating Fields. This therapy uses alternating electric fields to disrupt cancer cell division. According to the company, it’s the first time in nearly 30 years the FDA has green-lit a treatment for locally advanced pancreatic cancer.
Pancreatic cancer is still among the hardest cancers to tackle, especially since most people with locally advanced forms aren’t candidates for surgery. “With FDA approval, Optune Pax has the potential to be practice changing,” trial investigator Vincent Picozzi said in the company’s statement. SEC
NovoCure said patients in its Phase 3 PANOVA-3 study who received Optune Pax with gemcitabine and nab-paclitaxel had a median survival of 16.2 months. That’s a two-month improvement over the 14.2 months seen for those given only chemotherapy.
The median time before patients’ pain worsened extended to 15.2 months from 9.1 months. The company tracked pain progression as either a clear uptick in a patient’s reported pain score or death.
NovoCure CEO Frank Leonard described the approval as “the first new treatment in decades” for locally advanced pancreatic cancer, emphasizing that Optune Pax stands out as “fundamentally different” because of its biophysical mechanism. SEC
The FDA decision landed after the bell Wednesday. The company slipped the update into an 8-K, attaching its press release as an exhibit.
Even so, any early pop could lose steam as traders debate how quickly a wearable device like this might find traction in the cancer space, where chemo remains the standard. Insurance coverage and reimbursement? That’s a key swing factor. NovoCure pointed out that most Optune Pax patients experienced the expected skin issues from the device’s arrays, plus the usual chemo side effects.
Novocure shares soared as much as 34% in premarket trading, according to Investing.com data, a spike that caught the attention of several analysts.
NovoCure will report fourth-quarter results on Feb. 26. The U.S. launch remains front and center for investors, who are also likely to be listening for updates on the pancreatic label and its possible effects on 2026 forecasts.
