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BAAR, Switzerland - Japan’s Ministry of Health, Labour and Welfare has approved Novocure’s (NASDAQ:NVCR) Optune Lua device for concurrent use with PD-1/PD-L1 inhibitors in adult patients with unresectable advanced or recurrent non-small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy. The medical device company, currently valued at $1.36 billion, maintains a strong balance sheet with more cash than debt, according to InvestingPro data.
The approval is based on results from the Phase 3 LUNAR trial, which demonstrated a statistically significant 3.3-month improvement in median overall survival for patients treated with Optune Lua in combination with either PD-1/PD-L1 inhibitors or docetaxel compared to those treatments alone.
Patients receiving Optune Lua with a PD-1/PD-L1 inhibitor showed a median overall survival of 19.0 months versus 10.8 months for patients on a PD-1/PD-L1 inhibitor alone, representing an 8.0-month survival extension.
Optune Lua is a wearable medical device that delivers Tumor Treating Fields (TTFields), which are alternating electric fields that disrupt cancer cell division through non-invasive arrays worn by patients.
"With the Ministry of Health, Labour and Welfare approval granted to Optune Lua, we now have a new treatment option available to patients with advanced non-small cell lung cancer," said Dr. Tetsuya Mitsudomi, President of Izumi City General Hospital.
Device-related adverse events occurred in 63.1% of patients, primarily consisting of low-grade skin reactions where the transducer arrays were placed. Only 4% of patients experienced Grade 3 skin toxicity requiring treatment interruption, with no Grade 4 or 5 toxicities reported.
Lung cancer is the leading cause of cancer-related death worldwide, with approximately 120,000 patients diagnosed with NSCLC annually in Japan, according to the company’s press release statement. Despite reporting impressive revenue growth of 14.58% and maintaining a robust gross profit margin of 76.54%, Novocure’s stock has faced headwinds, declining 59% year-to-date. InvestingPro analysis suggests the stock is currently undervalued, with analysts setting price targets ranging from $14.50 to $38.00 per share. For detailed valuation metrics and additional insights, investors can access the comprehensive Pro Research Report, available exclusively on InvestingPro.
Novocure stated it is focused on launching Optune Lua in Japan as quickly as possible to provide access to patients who have progressed after initial platinum-based treatment. The company’s next earnings report is scheduled for October 23, where investors will gain further insights into the commercial rollout strategy and financial outlook.
In other recent news, Novocure Ltd announced the termination of its LUNAR-4 clinical trial for metastatic non-small cell lung cancer, citing the availability of real-world evidence. Meanwhile, Spain’s Ministry of Health has approved Novocure’s Tumor Treating Fields therapy for inclusion in the Spanish National Health System, making it available for adult patients with newly diagnosed glioblastoma. Additionally, Novocure has submitted a premarket approval application to the U.S. Food and Drug Administration for its Tumor Treating Fields therapy aimed at treating locally advanced pancreatic cancer, based on results from the PANOVA-3 clinical trial.
In analyst updates, Ladenburg Thalmann initiated coverage on Novocure with a Buy rating and a $30.00 price target, citing a positive outlook for its Optune Gio treatment in maintaining market share in glioblastoma multiforme. Furthermore, H.C. Wainwright has reiterated a Buy rating with a $38.00 price target for Novocure, following positive trial results for its cancer treatment. These recent developments highlight significant strides in Novocure’s therapeutic offerings and market perception.
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