Novocure Maintaining Course Towards Critical Breakthroughs
In a significant development for cancer treatment, biotech company Novocure has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Tumor Treating Fields (TTFields) therapy in locally advanced pancreatic cancer. This move comes following positive Phase 3 PANOVA-3 trial data, which showed significant improvement in median overall survival when TTFields was combined with gemcitabine and nab-paclitaxel versus chemotherapy alone [1][4]. The FDA decision on this application is expected in the second half of 2026.
For brain cancers, specifically brain metastases from non-small cell lung cancer (NSCLC), Novocure plans to submit a PMA application to the FDA in the second half of 2025, based on results from the Phase 3 METIS trial. However, as of now, this PMA submission is still in the planning stages [3].
Novocure's TTFields therapy represents a promising platform with minimal systemic toxicity, offering synergy with chemotherapy and immunotherapy. The company is also running Phase 2 trials combining TTFields with other agents such as atezolizumab in metastatic pancreatic cancer, with topline data expected in early 2026 [2].
For brain cancers like glioblastoma, Novocure currently markets Optune (TTFields device) combined with temozolomide for newly diagnosed patients. Phase 3 readouts for newly diagnosed glioblastoma (TRIDENT trial) are expected in the first half of 2026 [3].
The financial performance of Novocure in Q2 2025 reflects the company's investment in research and development. Novocure spent $55.8 million on research, development, and clinical studies, an increase of 2% from the same period in 2024. The company's revenue for Q2 2025 was $158.8 million, a 6% increase from Q2 2024. Revenue from Novocure's Optune Lua lung cancer treatment was $2.4 million in Q2 2025. Notably, Novocure is not yet profitable [5].
The number of active patients for Novocure increased by 9% to 4,331 in Q2 2025. CEO Ashley Cordova stated that it is a pivotal period for Novocure, with the company's future trajectory closely tied to the progress of its ongoing trials and FDA applications [6].
Investors should note that the stock is trading down more than 92% from its 2021 high due to disappointing results from a once-promising lung cancer trial. However, the ultimate trajectory of this stock remains very much tied to how these trials and FDA applications progress [7].
For more detailed information, Novocure's investor relations page is a valuable resource. The full earnings report is also available for review [8].
References:
[1] Novocure. (2025, August). Novocure Submits PMA Application for TTFields Therapy in Locally Advanced Pancreatic Cancer. Retrieved from https://www.novocure.com/news/novocure-submits-pma-application-for-ttfields-therapy-in-locally-advanced-pancreatic-cancer
[2] Novocure. (2025, August). Novocure Announces Phase 2 Trial of TTFields in Combination with Atezolizumab in Metastatic Pancreatic Cancer. Retrieved from https://www.novocure.com/news/novocure-announces-phase-2-trial-of-ttfields-in-combination-with-atezolizumab-in-metastatic-pancreatic-cancer
[3] Novocure. (2025, August). Novocure Announces PMA Plans for TTFields Therapy in Brain Metastases from NSCLC. Retrieved from https://www.novocure.com/news/novocure-announces-pma-plans-for-ttfields-therapy-in-brain-metastases-from-nsclc
[4] Novocure. (2025, August). Novocure Submits PMA Application for TTFields Therapy in Locally Advanced Pancreatic Cancer Based on PANOVA-3 Trial Data. Retrieved from https://www.novocure.com/news/novocure-submits-pma-application-for-ttfields-therapy-in-locally-advanced-pancreatic-cancer-based-on-panova-3-trial-data
[5] Yahoo Finance. (2025, August). Novocure Earnings Call Transcript. Retrieved from https://finance.yahoo.com/news/novocure-nvcr-q2-2025-earnings-call-transcript-063011681.html
[6] Seeking Alpha. (2025, August). Novocure Q2 2025 Earnings Call Transcript. Retrieved from https://seekingalpha.com/news/3800303-novocure-nvcr-q2-2025-earnings-call-transcript
[7] MarketWatch. (2025, August). Novocure stock up as the biotech company plans to seek FDA approval for its cancer treatment. Retrieved from https://www.marketwatch.com/story/novocure-stock-up-as-the-biotech-company-plans-to-seek-fda-approval-for-its-cancer-treatment-2025-08-26
[8] Novocure. (2025, August). Investor Relations. Retrieved from https://www.novocure.com/investors
- The financial investment in research and development by Novocure increased by 2% in Q2 2025, with a significant portion dedicated to clinical studies.
- The FDA decision on Novocure's premarket approval (PMA) application for TTFields therapy in locally advanced pancreatic cancer is expected in the second half of 2026.
- Investors should consider the stock's more than 92% drop from its 2021 high due to disappointing results from a trial, but the ultimate trajectory is tied to the progress of ongoing trials and FDA applications.
- Health-and-wellness professionals and medical-conditions researchers might find Novocure's TTFields therapy promising, especially in combination with chemotherapy and immunotherapy, as it offers significant improvement in median overall survival for certain cancer types.
