Novocure Soars 25% on FDA Breakthrough Device Designation
Novocure shares surged 25% after the FDA granted breakthrough device designation for its Tumor Treating Fields therapy in pancreatic cancer, extending its U.S. label beyond glioblastoma. The agency also lifted a clinical hold on the company’s Phase 3 ovarian cancer trial, allowing patient enrollment to resume.
1. FDA Grants Breakthrough Device Designation
The FDA awarded Novocure’s Tumor Treating Fields therapy breakthrough device status for pancreatic cancer, marking its first U.S. indication beyond glioblastoma. This designation provides priority review pathways and potential accelerated approval.
2. Shares Leap 25% on News
Novocure stock jumped 25% in intraday trading as investors priced in expanded commercial potential in a $4.5 billion pancreatic cancer market. Volume spiked to three times the 30-day average as buyers chased the regulatory win.
3. Clinical Hold Lifted on Phase 3 Trial
The FDA also removed a clinical hold on Novocure’s Phase 3 ovarian cancer study, enabling enrollment to restart. Completion of this trial is expected by mid-2027 and could unlock another multibillion-dollar opportunity.