NovoCure (NVCR) stock took off Thursday morning after regulatory authorities cleared the company’s cancer treatment device. The FDA approved Optune Pax for use in adult patients with locally advanced pancreatic cancer.
NovoCure Limited, NVCR
The device works in combination with two chemotherapy drugs: gemcitabine and nab-paclitaxel. This approval represents a major milestone for patients facing limited treatment options.
Shares jumped 29.33% before the opening bell. Despite Thursday’s rally, the stock still trades down 18.79% year-to-date and has dropped 51.64% over the past year.
The regulatory decision caught Wall Street by surprise. Analysts had expected approval sometime in the second quarter of 2026, not February.
The FDA’s decision rested on results from the PANOVA-3 clinical trial. Researchers enrolled 571 patients and split them evenly between two treatment groups.
Participants were monitored for at least 18 months. One group received Optune Pax alongside standard chemotherapy while the other got chemotherapy alone.
The study achieved its primary goal. Patients using Optune Pax demonstrated statistically improved median overall survival compared to the control group.
CEO Frank Leonard emphasized the treatment’s innovative approach. Traditional systemic therapies face challenges with bioavailability in pancreatic tumors, limiting their effectiveness.
Optune Pax operates differently. The device employs a biophysical method that targets the electrical properties of cancer cells rather than relying on conventional drug delivery.
H.C. Wainwright moved quickly to revise its forecast. The firm lifted its price target to $47 from $39 while maintaining its Buy recommendation.
The early approval timeline benefits NovoCure strategically. The company now has an extra quarter to stockpile inventory and negotiate reimbursement agreements with insurers.
H.C. Wainwright updated its financial projections accordingly. The firm raised its probability of success metric for pancreatic cancer applications from 70% to 100%.
The analyst also increased 2026 cost estimates. Higher projected expenses for cost of goods sold and SG&A reflect expected launch activities and inventory accumulation.
Wall Street analysts collectively rate the stock a Moderate Buy. The consensus includes four Buy ratings and two Hold ratings issued in the past three months.
The average analyst price target sits at $24.92. That figure suggests potential gains of 137% from current price levels.
Pre-market trading volume reached 399,000 shares Thursday. Normal daily volume averages 1.27 million shares over the past three months.
NovoCure disclosed preliminary 2025 revenue of $655.4 million earlier this year. That represents an 8% jump from 2024 figures.
Fourth-quarter revenue totaled $174.4 million. U.S. sales accounted for $101.6 million of the quarterly total.
H.C. Wainwright raised its NovoCure price target to $47 from $39 Thursday while keeping a Buy rating after the FDA approved Optune Pax.
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