NovoCure (NVO) Shares Jump 34% on FDA Approval of Optune Pax

On February 12, 2026, the U.S. Food and Drug Administration granted Breakthrough Therapy designation and cleared the marketing application for NovoCure (NVO)’s Optune Pax, an epilepsy treatment device. The decision follows positive results from pivotal trials and is expected to expedite commercial launch and global availability. The stock surged 34% in after-hours trading, reflecting market confidence in the device's potential to expand NovoCure’s revenue and strengthen its position in the neurology therapies segment. The Breakthrough Therapy designation is expected to support a faster approval pathway, potentially reducing time-to-market by up to 12 months.