Novocure Stock Slips After FDA Rejects Its Cancer Treatment Device

Novocure Ltd. (NASDAQ:NVCR) on Monday received a Not Approvable Letter from the U.S. Food and Drug Administration (FDA) in response to its Premarket Approval (PMA) application for Optune Mya for adult patients with brain metastases from non-small cell lung cancer following stereotactic radiation.

The Not Approvable Letter indicates that the FDA determined that uncertainty around the degree of clinical benefit provided by Optune Mya prevented approval of the PMA application.

Tumor Treating Fields: How Optune Mya Works

Optune Mya uses the company’s Tumor Treating Fields technology, which applies electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing cancer cells to die.

Phase 3 TRIDENT Study Findings and Glioblastoma Survival Endpoints

In June, Novocure reported topline results from its Phase 3 TRIDENT study in a separate indication, newly diagnosed glioblastoma, showing that starting Tumor Treating Fields (TTFields) therapy during chemoradiation did not significantly improve overall survival compared with initiating the therapy during the maintenance phase.

The trial failed to meet its primary endpoint of improving overall survival. In the intent-to-treat population, patients in the Early Start Arm achieved a median overall survival of 17.7 months, compared with 17.5 months in the Maintenance Start Arm.

Regulatory Next Steps and Pathway to Approval

The FDA did not raise concerns related to the safety profile of Optune Mya. Novocure is evaluating the feedback and plans to meet with the FDA to determine if there are any options that would support approval of the PMA application that would not require additional clinical studies.

There can be no assurance that these discussions or any future submissions regarding this PMA application will lead to an approval.

Earnings Overview

In October, the company reported quarterly revenues of $193.4 million, beating the consensus of $182.233 million, an increase of 16% year over year, primarily driven by 19% global active patient growth.

Net revenue from Optune Lua and Optune Pax in the quarter was $11.9 million.

Novocure raised its fiscal 2026 sales guidance from $710 million-$725 million to $736 million-$743 million compared to the consensus of $725.81 million.

Adjusted EBITDA is expected to be between $24 million and $34 million, compared with prior guidance of $0 to $15 million.

NVCR Price Action: Novocure shares were down 1.84% at $13.04 at the time of publication on Monday, according to Benzinga Pro data.

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