TLDR
- NovoCure (NVCR) stock gained 29.33% in pre-market Thursday after FDA approved Optune Pax for locally advanced pancreatic cancer treatment.
- Regulatory clearance came one quarter earlier than expected, originally anticipated in Q2 2026.
- PANOVA-3 Phase 3 trial with 571 patients met primary endpoint, showing improved median overall survival rates.
- H.C. Wainwright upgraded price target from $39 to $47, adjusting probability of success to 100% from 70%.
- First new treatment approved for locally advanced pancreatic cancer in decades using biophysical approach.
NovoCure (NVCR) stock posted strong gains Thursday after the company received regulatory approval for its cancer treatment device. The FDA cleared Optune Pax for use in adults with locally advanced pancreatic cancer.
The device pairs with chemotherapy drugs gemcitabine and nab-paclitaxel. Patients receive the combination therapy as part of their treatment protocol.
Shares rose 29.33% in pre-market trading. The stock remains down 18.79% for the year and has fallen 51.64% over the past 12 months.
The approval timeline surprised market watchers. Most analysts had projected regulatory clearance would come in the second quarter of 2026.
Trial Results Support FDA Decision
The FDA based its approval on PANOVA-3 trial outcomes. The Phase 3 study randomized 571 patients into two equal groups.
Researchers tracked participants for a minimum of 18 months. Half received Optune Pax with standard chemotherapy while the other half got chemotherapy only.
The trial hit its primary endpoint successfully. Patients using Optune Pax showed statistically better median overall survival versus the control group.
CEO Frank Leonard highlighted the treatment gap this approval fills. He noted that systemic therapies have struggled with poor bioavailability in pancreatic tumors.
Optune Pax uses a different mechanism. The technology targets electrical properties of cancer cells through a biophysical approach instead of traditional drug-based methods.
Wall Street Revises Forecasts
H.C. Wainwright adjusted its outlook following the news. The firm increased its price target to $47 from $39 and kept its Buy rating intact.
The early approval gives NovoCure extra preparation time. The company can spend an additional quarter building inventory and establishing reimbursement pathways.
H.C. Wainwright revised its financial model after the announcement. The firm now assigns 100% probability of success for pancreatic cancer applications, up from 70%.
The analyst raised 2026 expense projections as well. Higher estimates for cost of goods sold and SG&A account for launch investments and inventory buildup.
Analysts maintain a Moderate Buy consensus on the stock. Four recommend buying while two rate it a Hold based on recent research.
Stock Performance and Valuation
The average analyst price target stands at $24.92. That implies upside potential of 137% from current trading levels.
Pre-market volume hit 399,000 shares Thursday morning. Typical daily volume runs around 1.27 million shares based on three-month averages.
NovoCure reported preliminary 2025 revenue of $655.4 million. That figure represents an 8% increase over the previous year.
Fourth-quarter revenue came in at $174.4 million. The U.S. market generated $101.6 million of quarterly sales.
The company received its first new pancreatic cancer treatment approval in decades. Optune Pax uses a biophysical approach targeting cancer cell electrical properties.
H.C. Wainwright raised its NovoCure price target to $47 from $39 Thursday following FDA approval of Optune Pax for pancreatic cancer treatment.
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