FDA Rejects NovoCure’s Optune Mya for Lung Cancer Brain Metastases. Here's What It Means for Investors.

One stock that took a hard hit at the beginning of the trading week was that of specialty medical device maker NovoCure (NASDAQ:NVCR). Investors sold out of the company aggressively after news that one of its products met its primary endpoint but fell short of key secondary endpoints in a crucial late-stage clinical trial. The shares initially swooned at a double-digit rate, but recovered, ending the day less than 6% lower. Does this make the unique healthcare stock a buy on the dip?

The FDA says no

That morning, NovoCure announced that it received a not approvable letter from the Food and Drug Administration (FDA) for its investigational device, Optune Mya. The company had submitted a premarket approval (PMA) application for the product to be accepted for the treatment of adults with non-small cell lung cancer that has metastasized to the brain and who have undergone targeted radiation for their brain tumors.

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In its press release announcing the news, NovoCure wrote that the regulator's letter "indicates that the FDA determined that uncertainty around the degree of clinical benefit provided by Optune Mya prevented approval of the PMA application."

The company added that the FDA raised no concerns about Optune Mya's safety profile. It stated that it is currently evaluating the FDA's response and aims to meet with agency officials to determine whether there is a path to obtain approval for the device without further clinical studies.

A set of innovative devices

NovoCure's three approved devices are all part of the Optune "family." These products use an innovative technology called tumor treating fields (TTFields). These are low-intensity, alternating electric fields that disrupt the division -- and therefore the spread -- of cancer cells.

The three FDA-approved Optunes are led by the original device, now known as the Gio, which targets glioblastoma (an aggressive form of brain cancer). The second is the Lua, indicated for two forms of thoracic cancer. The third is the Pax, aimed at pancreatic cancer.

The Optunes are well-established as non-traditional cancer treatment solutions used alongside standard ones such as chemotherapy. The Gio, once known simply as Optune, earned its first approval in 2011, followed by the Lua in 2019 and the Pax early this year.

Of the three, the Gio is NovoCure's top revenue generator and has the largest patient base. At the end of the third quarter, 4,729 individuals were actively using the device, an 11% increase over the same period of 2025. It's approved in various jurisdictions abroad, so that patient population includes users in Japan, Germany, and France. Lua's patient count grew by 83% to 255, while the still-new Pax had 276.

Revolutionary rival

Despite those growth numbers -- and a total revenue line that increased 16% to $193 million -- NovoCure remains habitually unprofitable. Its third-quarter loss was over $10.4 million, although that was much narrower than the year-ago deficit of over $37.2 million.

But even a skinnier bottom-line shortfall and management's raised guidance for revenue and adjusted earnings before interest, taxes, depreciation, and amortization (EBITDA) for full-year 2026 couldn't lift the stock. Investors were concerned about the timing of the Pax rollout, as it coincides with the FDA's late-August approval of biotech Revolution Medicines' (NASDAQ:RVMD) Rasonque pill for stage 4 metastatic cancer. NovoCure's quarterly performance wasn't strong enough to overcome these fears, and the stock fell and remains in a slump. The FDA's rejection of the Mya is only adding to that negative sentiment.

So is NovoCure's beaten-down equity worthy of an investment? I'd be inclined to say no. Although Pax and Rasonque treat different forms of pancreatic cancer (albeit with some overlap), it's the pill that currently seems to have a better chance of becoming a go-to treatment for the affliction. Gio feels like a maturing product, meanwhile, and despite Lua's recent growth, its patient base remains small. And since the requirements for a PMA to be green-lit are quite strict, Mya's journey to eventual approval could be long and difficult.

Eric Volkman has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends NovoCure. The Motley Fool has a disclosure policy.