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AUSTIN, Texas - Natera, Inc. (NASDAQ:NTRA), a diagnostics company with a market capitalization of $22.37 billion and impressive revenue growth of 44% over the last twelve months, announced Monday that a phase III clinical trial using its Signatera blood test to guide treatment decisions in muscle-invasive bladder cancer has achieved positive results. According to InvestingPro data, the company maintains a healthy gross profit margin of 63% and strong liquidity with a current ratio of 3.72.
The IMvigor011 trial, sponsored by Genentech, demonstrated that patients who tested positive for circulating tumor DNA (ctDNA) using Signatera and received atezolizumab (Tecentriq) showed statistically significant improvements in both disease-free survival and overall survival compared to those receiving placebo. This breakthrough comes as Natera’s stock has delivered a 31.5% return over the past year, reflecting strong market confidence in the company’s innovations. For deeper insights into Natera’s performance and growth potential, InvestingPro subscribers can access comprehensive research reports and 12 additional expert tips.
The trial enrolled approximately 760 post-surgery patients who underwent serial Signatera testing for up to 12 months. Patients who tested positive for molecular residual disease (MRD) but had no visible cancer on imaging were randomized to receive either atezolizumab or placebo for up to one year.
A preliminary analysis presented at the European Association of Urology in April 2024 showed that patients who consistently tested negative with Signatera had excellent outcomes without additional treatment, with 98% overall survival at 18 months.
"The results of IMvigor011 are very significant, opening the door for a new treatment paradigm for bladder cancer patients who are positive for recurrence on a molecular level but have no evidence of disease on imaging," said Professor Thomas Powles, lead principal investigator of the study.
Natera plans to finalize its premarket approval application to the U.S. Food and Drug Administration for Signatera as a companion diagnostic for selecting muscle-invasive bladder cancer patients for atezolizumab treatment after surgery.
The company indicated that complete trial data will be presented at an upcoming medical conference.
This is the first prospective phase III study in muscle-invasive bladder cancer to report results using a personalized, ctDNA-guided approach to treatment decisions, according to the company’s press release statement.
In other recent news, Natera reported its second-quarter 2025 earnings, revealing a revenue of $546.6 million, which exceeded forecasts by 14.85%. However, the company’s earnings per share (EPS) was -$0.74, missing the expected -$0.62. Despite the EPS miss, the strong revenue growth led to a positive market reaction. In response to this performance, RBC Capital raised its price target for Natera to $255 from $251, maintaining an Outperform rating. Similarly, Bernstein SocGen Group increased its price target to $205 from $200, also keeping an Outperform rating, noting the company’s revenue strength. TD Cowen followed suit, adjusting its price target to $215 from $200, while maintaining a Buy rating. These adjustments reflect the analysts’ confidence in Natera’s financial health despite the mixed earnings report.
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