Overview
- The FDA cleared Optune Pax for adult patients with locally advanced pancreatic cancer after the Phase 3 PANOVA-3 trial showed a statistically significant overall survival benefit versus chemotherapy alone in 571 patients.
- NovoCure shares jumped about 29% in pre-market trading following the approval, though the stock remains down roughly 19% year to date and 52% over the past 12 months.
- Regulatory clearance arrived roughly a quarter earlier than analysts expected, giving the company extra time to build inventory and negotiate reimbursement with insurers.
- Optune Pax is used with gemcitabine and nab-paclitaxel and uses a biophysical approach that targets the electrical properties of cancer cells.
- H.C. Wainwright raised its price target to $47 and increased its pancreatic success probability to 100% while maintaining a Buy rating.