Novocure (NASDAQ:NVCR) surged as much as 34% in premarket trading on Thursday after securing U.S. regulatory approval for its wearable therapy designed to treat pancreatic cancer.
The U.S. Food and Drug Administration cleared Optune Pax for use in patients with locally advanced pancreatic cancer in combination with chemotherapy agents gemcitabine and nab-paclitaxel. The decision arrived sooner than many analysts had expected.
Optune Pax delivers Tumor Treating Fields, a technology that uses electric fields to interfere with cancer cell division while sparing healthy cells. In Phase 3 studies, the therapy extended overall survival by two months compared with chemotherapy alone.
The treatment also delayed pain progression by 6.1 months. The most frequently reported device-related side effects were mild to moderate skin irritation beneath the electrode arrays.
Wells Fargo analyst Larry Biegelsen highlighted the earlier-than-anticipated approval, estimating pancreatic cancer-related sales of about $6 million in 2027, rising to roughly $104 million by 2030.