TLDR
- NovoCure (NVCR) stock surged 29.33% in pre-market trading after FDA approved Optune Pax for locally advanced pancreatic cancer.
- FDA approval arrived a quarter earlier than Wall Street expected, originally projected for Q2 2026.
- PANOVA-3 trial with 571 patients demonstrated statistically improved overall survival versus standard chemotherapy alone.
- H.C. Wainwright boosted price target to $47 from $39 and increased probability of success estimates to 100%.
- Optune Pax represents first new treatment option for locally advanced pancreatic cancer in decades.
NovoCure (NVCR) stock rocketed higher Thursday after the company secured FDA approval for Optune Pax. The device treats locally advanced pancreatic cancer in combination with chemotherapy drugs gemcitabine and nab-paclitaxel.
The regulatory clearance came as a surprise to analysts. Most had penciled in a Q2 2026 approval timeline, giving NovoCure an unexpected extra quarter to prepare.
Shares jumped 29.33% in pre-market trading. The stock remains down 18.79% year-to-date and has fallen 51.64% over the past 12 months despite Thursday’s gains.
Strong Clinical Trial Results Drive Approval
The FDA based its decision on PANOVA-3 trial data. The Phase 3 study randomized 571 patients into two groups with a minimum 18-month follow-up period.
One group received Optune Pax plus standard chemotherapy. The control group got chemotherapy alone.
The trial met its primary endpoint. Patients treated with Optune Pax showed statistically better median overall survival rates.
CEO Frank Leonard called it the first new treatment in decades for this patient population. Systemic therapies have struggled with poor bioavailability in pancreatic tumors.
Optune Pax uses a biophysical approach instead. The device targets unique electrical properties of cancer cells rather than relying on traditional drug delivery methods.
Wall Street Responds to Early Approval
H.C. Wainwright wasted no time updating its outlook. The firm raised its price target to $47 from $39 while keeping a Buy rating.
The earlier approval timeline gives NovoCure breathing room. The company can now focus an additional quarter on inventory buildup and reimbursement negotiations.
H.C. Wainwright adjusted its financial model following the news. The firm increased probability of success for pancreatic cancer to 100% from 70%.
The firm also boosted 2026 estimates for cost of goods sold and SG&A expenses. These increases reflect anticipated launch investments and inventory preparation.
Wall Street maintains a Moderate Buy consensus rating on the stock. Four analysts recommend buying shares while two rate it a Hold.
The average price target stands at $24.92. That implies potential upside of 137% from current levels.
Revenue and Trading Activity
Pre-market volume hit 399,000 shares Thursday morning. That compares to a three-month daily average of 1.27 million shares.
NovoCure previously reported preliminary 2025 revenue of $655.4 million. That marked an 8% increase from the prior year.
Fourth-quarter revenue reached $174.4 million. The U.S. market contributed $101.6 million of that total.
H.C. Wainwright raised its price target on NovoCure to $47 from $39 Thursday while maintaining a Buy rating following the FDA approval.
