Natera Stock Tumbles 1.15 as $240M Volume Ranks 394th Amid Phase III Trial Success in Bladder Cancer

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Monday, Aug 18, 2025 6:50 pm ET1min read
NTRA--
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- Natera's Signatera ctDNA test showed positive phase III results in muscle-invasive bladder cancer, demonstrating statistically significant survival improvements for atezolizumab-treated patients.

- The Genentech-sponsored IMvigor011 trial identified molecular residual disease post-surgery, with 98% 18-month survival for Signatera-negative patients avoiding additional treatment.

- Natera plans FDA premarket approval submission for Signatera as atezolizumab companion diagnostic, aiming to establish a new treatment paradigm for molecular recurrence detection.

- Despite trial success, Natera stock fell 1.15% with $240M trading volume, ranking 394th in U.S. stocks amid mixed market reactions to biotech developments.

Natera (NASDAQ:NTRA) closed August 18 with a 1.15% decline, trading on $240 million in volume that ranked it 394th among U.S. stocks. The biotech firm announced positive phase III clinical trial results for its Signatera ctDNA test in muscle-invasive bladder cancer, showing statistically significant improvements in disease-free and overall survival for patients receiving atezolizumab treatment. The IMvigor011 trial, sponsored by Genentech, demonstrated the test's ability to identify patients with molecular residual disease post-surgery who benefit from immunotherapy. Approximately 760 participants underwent serial testing, with those remaining Signatera-negative showing excellent outcomes without additional treatment.

The trial marks the first prospective phase III study using a personalized ctDNA-guided approach for bladder cancer management. NateraNTRA-- plans to submit a premarket approval application to the FDA for Signatera as a companion diagnostic for atezolizumab treatment. Preliminary data from the study showed 98% overall survival at 18 months for Signatera-negative patients. Principal investigator Professor Thomas Powles highlighted the potential for a new treatment paradigm for patients with molecular recurrence but no visible disease on imaging. Natera also announced plans to present full trial results at an upcoming medical conference.

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