TLDR
- NovoCure (NVCR) stock jumped 29% in pre-market trading Thursday after FDA approved Optune Pax for locally advanced pancreatic cancer treatment.
- The approval came earlier than expected, originally anticipated for Q2 2026, giving the company extra time for launch preparation and reimbursement processes.
- Phase 3 PANOVA-3 trial met its primary endpoint with 571 patients showing statistically improved median overall survival rates.
- H.C. Wainwright raised its price target from $39 to $47 following the approval, increasing probability of success estimates from 70% to 100%.
- This marks the first new treatment in decades for locally advanced pancreatic cancer, using a biophysical approach targeting electrical properties of cancer cells.
NovoCure (NVCR) stock soared Thursday morning after receiving regulatory approval that caught Wall Street off guard. The FDA greenlit Optune Pax for treating locally advanced pancreatic cancer, arriving a full quarter ahead of analyst expectations.
The approval allows Optune Pax to be used alongside chemotherapy drugs gemcitabine and nab-paclitaxel for adult patients. This combination therapy represents the first new treatment option for this patient population in decades.
The regulatory win stems from strong Phase 3 trial data. The PANOVA-3 study enrolled 571 patients who were randomly assigned to receive either the combination therapy with Optune Pax or standard chemotherapy alone.
Patients were followed for at least 18 months. The trial hit its primary goal of showing statistically better overall survival for those treated with Optune Pax.
CEO Frank Leonard highlighted the treatment’s unique mechanism. Unlike traditional systemic therapies that struggle with poor bioavailability in pancreatic tumors, Optune Pax takes a different route.
Market Reaction and Analyst Response
The device uses a biophysical approach that targets the electrical properties of cancer cells. This fundamentally different strategy addresses limitations that have hampered previous treatment efforts.
Shares jumped 29.33% in pre-market trading Thursday. The stock had inched higher the previous session but remains down 18.79% year-to-date and 51.64% over the past year.
Pre-market volume reached 399,000 shares, well below the three-month average daily volume of 1.27 million shares. Wall Street analysts maintain a Moderate Buy consensus rating on the stock.
The rating comes from four Buy recommendations and two Hold ratings issued over the past three months. The average price target sits at $24.92, implying 137% upside potential.
Analyst Upgrades and Financial Outlook
H.C. Wainwright moved quickly to adjust its outlook. The firm raised its price target to $47 from $39 while keeping its Buy rating intact.
The earlier-than-expected approval gives NovoCure an extra quarter to build inventory and establish reimbursement pathways. The firm updated its financial model to reflect 100% probability of success in pancreatic cancer, up from 70%.
H.C. Wainwright also increased its 2026 estimates for cost of goods sold and SG&A expenses. These adjustments account for inventory buildup and launch-related investments.
The company previously reported preliminary 2025 revenue of $655.4 million, up 8% from the prior year. Fourth-quarter revenue came in at $174.4 million, with the U.S. market contributing $101.6 million.
H.C. Wainwright raised its price target on NovoCure to $47 from $39 Thursday while maintaining a Buy rating on the stock.
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