NovoCure Lawsuit Dismissed: FDA Approval Undercut Fraud Claims

The securities class action against NovoCure Limited over its LUNAR lung cancer trial was dismissed on March 18, 2025, when Judge Gregory H. Woods of the U.S. District Court for the Southern District of New York ruled that the investors’ allegations described a scientific disagreement about clinical trial design, not securities fraud. Final judgment for the defendants was entered on April 9, 2025, after the lead plaintiff declined to file another amended complaint.¹

What Investors Alleged

The case, Bazzelle, Sr. v. NovoCure Limited, was filed on June 19, 2023 against NovoCure, Executive Chairman William Doyle, and CEO Asaf Danziger. It covered a class period running from January 5, 2023 through June 5, 2023.¹

The dispute traced back to how NovoCure described its Phase 3 LUNAR study of Tumor Treating Fields therapy in metastatic non-small cell lung cancer. On January 5, 2023, NovoCure announced that LUNAR had met its primary endpoint, showing “a statistically significant and clinically meaningful improvement in overall survival.” Doyle called the results the start of “a transformational period,” and Danziger described them as the beginning of “a transformational 24 months.”² The stock jumped.

When NovoCure presented the full data at the American Society of Clinical Oncology meeting on June 5, 2023, oncologists and analysts questioned the trial’s design. The concern was that the role of immune checkpoint inhibitors had shifted since the study was designed, so the control arm did not reflect how patients were being treated in current practice. The stock fell from $82.51 to $47.00, a drop of roughly 43%, erasing about $3.5 billion in market value.³

The complaint argued that the January statements were “half-truths at best” because NovoCure had not disclosed that only a small share of trial participants received the current standard of care, and that the control arm did not represent real-world clinical settings. Plaintiffs also accused Danziger of insider trading, alleging he exercised options and sold shares on January 5, 2023 at roughly $108 to $120 per share for more than $23 million in proceeds.²

Why the Court Dismissed the Case

Judge Woods granted the defendants’ motion to dismiss in full, finding that the plaintiffs failed to adequately plead either falsity or scienter, the intent element required for securities fraud. He gave leave to amend, but the plaintiff chose not to try again.⁴

On falsity, the court read the complaint as a quarrel with how NovoCure had designed and interpreted its trial. The allegations, Judge Woods wrote, amounted “at most” to claims that the trial “should’ve had a different design” or that the plaintiff’s “interpretation of the data was better than NovoCure’s.” He added that “securities law is simply not a vehicle through which courts will police disagreements in the cancer research community or the parameters of clinical trials.”⁵

On scienter, the court found that Danziger’s stock trades were non-discretionary, which cut against any inference of fraudulent intent. The court also treated NovoCure’s decision to plan additional trials as consistent with ordinary scientific progress rather than an attempt to paper over problems with LUNAR.⁵

The ruling tracks a line of Second Circuit decisions holding that disputes over the reading of clinical data do not support fraud claims when the defendant’s interpretation is reasonable. Under a related 2023 Second Circuit decision, when the FDA ultimately endorses a company’s reading of trial data, that reading is “per se reasonable as a matter of law.” And even without FDA agreement, an opinion about trial results is not misleading if the defendant conducted a genuine inquiry and actually held the view expressed.⁴

How the FDA Approval Cut Against the Fraud Theory

By the time the motion to dismiss was decided, the FDA had validated the underlying data. On October 15, 2024, the agency approved Optune Lua for metastatic non-small cell lung cancer, relying on the same LUNAR trial results that the investors’ complaint had characterized as misleading.⁶ The approval came even though analysts had raised the same trial design concerns that formed the heart of the lawsuit.⁷ That approval made it harder for plaintiffs to argue that NovoCure’s positive characterization of the January 2023 results was unreasonable.

What Happened After the Dismissal

Along the case’s procedural path, the court had appointed Clendon T. Rice as lead plaintiff on August 29, 2023 and approved Robbins Geller Rudman & Dowd LLP as lead counsel. Rice filed an amended complaint on November 13, 2023, and the defendants moved to dismiss on March 4, 2024.¹

After the March 2025 dismissal, Rice notified the court on April 8, 2025 that he would not file a second amended complaint. Judge Woods directed the clerk to enter final judgment for the defendants the same day, and the case was closed on April 9, 2025.¹ No appeal has been publicly reported.⁸

1
Stanford Law School Securities Class Action Clearinghouse. NovoCure Limited Securities Litigation
2
Saxena White. NovoCure Complaint
3
BusinessWire. NovoCure Deadline Alert
4
Bloomberg Law. NovoCure Beats Investor Lawsuit Over Cancer Trial Data Results
5
Sidley Austin. Sidley Secures Securities Litigation Victory on Behalf of NovoCure
6
FDA. Optune Lua PMA Approval
7
BioPharma Dive. NovoCure FDA Lung Cancer Approval
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Bloomberg Law. NovoCure Escapes Investor Suit Over Cancer Therapy Trial Data