Natera Submits PMA for MRD Detection in Bladder Cancer
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 02 2026
0mins
Should l Buy NTRA?
Source: Newsfilter
- Clinical Trial Success: Natera's IMvigor011 trial demonstrated that bladder cancer patients treated with atezolizumab and guided by Signatera™CDx showed statistically significant improvements in disease-free and overall survival, highlighting the test's potential in personalized therapy.
- FDA Application Submission: Natera has submitted a premarket approval application for Signatera™CDx to the FDA, marking a significant step toward making MRD-guided treatment a reality for muscle-invasive bladder cancer patients, potentially becoming the first companion diagnostic MRD test if approved.
- Strong Market Demand: Bladder cancer is the sixth most common cancer in the U.S., with muscle-invasive cases representing 20-25% of new diagnoses; the introduction of Signatera™CDx will aid in identifying high-recurrence-risk patients, enabling more effective personalized treatment options.
- Strategic Implications: Natera aims to integrate personalized genetic testing into standard care, and the successful launch of Signatera™CDx could not only enhance patient outcomes but also solidify the company's leadership position in the precision medicine sector.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy NTRA?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on NTRA
Wall Street analysts forecast NTRA stock price to rise
13 Analyst Rating
12 Buy
1 Hold
0 Sell
Strong Buy
Current: 205.220
Low
205.00
Averages
262.92
High
300.00
Current: 205.220
Low
205.00
Averages
262.92
High
300.00
About NTRA
Natera, Inc. provides cell-free DNA (cfDNA) and genetic testing, dedicated to oncology, women’s health, and organ health. The Company's cfDNA technology platform combines novel molecular biology techniques with bioinformatics software and artificial intelligence. It has leveraged its platform to develop non-invasive prenatal test on the market (Panorama), the first tumor-specific assay for truly individualized cancer care (Signatera), best-in-class rejection assessment for kidney transplantation (Prospera) and others. In the women’s health space, it develops and commercializes non- or minimally- invasive tests to evaluate risk for, and thereby enable early detection of, a range of genetic conditions, such as Down syndrome. In oncology, it is focused on detecting molecular residual disease and recurrence monitoring in solid tumors, among others. In organ health, it offers tests to assess kidney, heart, and lung transplant rejection as well as genetic testing for chronic kidney disease.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Natera (NTRA.US) Officer Plans to Sell $3.31 Million in Common Stock via Form 144
Stock Sale Announcement: Officer Daniel Rabinowitz intends to sell 16,798 shares of its common stock on March 6, with a total market value of approximately $3.31 million.
Reduction in Shareholding: Daniel Rabinowitz has reduced his shareholding in Natera (NTRA.US) by 22,892 shares since January 20, 2026, with a total value of approximately $5.38 million.
See More
Exelixis Aims to Expand Beyond Cabozantinib Franchise
- Significant Revenue Growth: In 2025, Exelixis reported a 7% revenue increase to $2.3 billion, primarily driven by its cabozantinib franchise, which not only solidifies its market position but also funds future research and development efforts.
- Improved Profitability: Earnings per share (EPS) reached $2.78, up 57.9%, reflecting the company's success in cost control and sales growth, which further boosts investor confidence in its financial health.
- New Drug Application Approval: The FDA approved the New Drug Application for zanzalintinib in combination with atezolizumab for metastatic colorectal cancer on February 2, with a final decision expected by December 3, potentially opening new revenue streams for the company.
- Expanded Partnerships: Exelixis has partnered with companies like Takeda and Ipsen to sell cabozantinib in Japan, while also collaborating with Natera for clinical trials of zanzalintinib, enhancing its market penetration and research capabilities.
See More
Exelixis Aims to Become a Top Oncology Player with Expanding Pipeline
- Drug Diversification: Exelixis' lead drug cabozantinib (Cabometyx and Cometriq) is approved for kidney, thyroid, and liver cancers, and is currently in a phase 3 trial for advanced neuroendocrine tumors in the lung, thymus, and gastrointestinal tract, which is expected to enhance its market share.
- New Drug Approval: The FDA approved zanzalintinib in combination with atezolizumab for metastatic colorectal cancer on February 2, with a final decision on its application due by December 3, which could significantly bolster Exelixis' product portfolio if successful.
- Strategic Partnerships: Exelixis collaborates with Takeda and Ipsen to sell cabozantinib in Japan, and has partnered with Natera to utilize its Signatera assay for identifying colorectal cancer patients, enhancing the efficacy of zanzalintinib's clinical trials.
- Strong Financial Performance: In 2025, Exelixis reported a 7% revenue increase to $2.3 billion, primarily from cabozantinib, with earnings per share (EPS) reaching $2.78, up 57.9%, reflecting the company's robust market performance and profitability.
See More
Signatera MRD Enhances Quality of Life in Genitourinary Cancers
- Clinical Trial Results: Natera's presentation of 11 scientific abstracts at ASCO GU, including 4 oral presentations, underscores the potential of Signatera MRD in enhancing the quality of life for patients with genitourinary cancers, particularly in muscle-invasive bladder cancer (MIBC).
- Treatment Response Monitoring: The INDIBLADE and RETAIN multicenter phase 2 trials demonstrate consistent performance of Signatera in monitoring treatment responses across various neoadjuvant regimens, with 73-77% of patients showing ctDNA clearance post-therapy, indicating its critical role in bladder preservation strategies.
- Survival Rate Improvement: The INDIBLADE study reveals that Signatera-negative patients post-ICI treatment achieve a bladder-intact event-free survival (BI-EFS) rate of up to 91%, highlighting Signatera's potential in optimizing clinical decisions, especially in bladder preservation therapies.
- Innovative Risk Stratification: The NIAGARA study presents the first-ever correlation of urinary tumor DNA (utDNA) data with clinical outcomes, suggesting that the combined assessment of utDNA and ctDNA can provide comprehensive risk stratification for residual disease, aiding physicians in identifying patients who may require additional therapy.
See More
Natera Reports Record Q4 2025 Earnings with Strong Growth
- Significant Revenue Growth: Natera reported approximately $666 million in revenue for Q4 2025, reflecting a 40% increase year-over-year and exceeding expectations by $6 million, indicating strong market performance and sustained demand growth.
- Innovative Testing Volume: The company processed about 924,000 tests in Q4, with 225,000 MRD clinical units, marking a 56% increase from the previous year, which not only enhances market share but also strengthens its competitive position in precision medicine.
- Margin Improvement: Natera achieved a gross margin of 66.9%, with expectations to maintain margins between 63% and 65% in 2026, demonstrating ongoing improvements in cost control and operational efficiency that will support future profitability.
- Robust Cash Flow: The company generated over $100 million in cash flow for 2025, with a pristine balance sheet showing over $1 billion in cash and securities, reflecting a strong financial foundation to support future investments and growth.
See More
Natera (NTRA) Q4 2025 Earnings Call Transcript
See More
Natera (NTRA.US) Officer Plans to Sell $3.31 Million in Common Stock via Form 144
Stock Sale Announcement: Officer Daniel Rabinowitz intends to sell 16,798 shares of its common stock on March 6, with a total market value of approximately $3.31 million.
Reduction in Shareholding: Daniel Rabinowitz has reduced his shareholding in Natera (NTRA.US) by 22,892 shares since January 20, 2026, with a total value of approximately $5.38 million.
See More
Exelixis Aims to Expand Beyond Cabozantinib Franchise
- Significant Revenue Growth: In 2025, Exelixis reported a 7% revenue increase to $2.3 billion, primarily driven by its cabozantinib franchise, which not only solidifies its market position but also funds future research and development efforts.
- Improved Profitability: Earnings per share (EPS) reached $2.78, up 57.9%, reflecting the company's success in cost control and sales growth, which further boosts investor confidence in its financial health.
- New Drug Application Approval: The FDA approved the New Drug Application for zanzalintinib in combination with atezolizumab for metastatic colorectal cancer on February 2, with a final decision expected by December 3, potentially opening new revenue streams for the company.
- Expanded Partnerships: Exelixis has partnered with companies like Takeda and Ipsen to sell cabozantinib in Japan, while also collaborating with Natera for clinical trials of zanzalintinib, enhancing its market penetration and research capabilities.
See More
Exelixis Aims to Become a Top Oncology Player with Expanding Pipeline
- Drug Diversification: Exelixis' lead drug cabozantinib (Cabometyx and Cometriq) is approved for kidney, thyroid, and liver cancers, and is currently in a phase 3 trial for advanced neuroendocrine tumors in the lung, thymus, and gastrointestinal tract, which is expected to enhance its market share.
- New Drug Approval: The FDA approved zanzalintinib in combination with atezolizumab for metastatic colorectal cancer on February 2, with a final decision on its application due by December 3, which could significantly bolster Exelixis' product portfolio if successful.
- Strategic Partnerships: Exelixis collaborates with Takeda and Ipsen to sell cabozantinib in Japan, and has partnered with Natera to utilize its Signatera assay for identifying colorectal cancer patients, enhancing the efficacy of zanzalintinib's clinical trials.
- Strong Financial Performance: In 2025, Exelixis reported a 7% revenue increase to $2.3 billion, primarily from cabozantinib, with earnings per share (EPS) reaching $2.78, up 57.9%, reflecting the company's robust market performance and profitability.
See More
Signatera MRD Enhances Quality of Life in Genitourinary Cancers
- Clinical Trial Results: Natera's presentation of 11 scientific abstracts at ASCO GU, including 4 oral presentations, underscores the potential of Signatera MRD in enhancing the quality of life for patients with genitourinary cancers, particularly in muscle-invasive bladder cancer (MIBC).
- Treatment Response Monitoring: The INDIBLADE and RETAIN multicenter phase 2 trials demonstrate consistent performance of Signatera in monitoring treatment responses across various neoadjuvant regimens, with 73-77% of patients showing ctDNA clearance post-therapy, indicating its critical role in bladder preservation strategies.
- Survival Rate Improvement: The INDIBLADE study reveals that Signatera-negative patients post-ICI treatment achieve a bladder-intact event-free survival (BI-EFS) rate of up to 91%, highlighting Signatera's potential in optimizing clinical decisions, especially in bladder preservation therapies.
- Innovative Risk Stratification: The NIAGARA study presents the first-ever correlation of urinary tumor DNA (utDNA) data with clinical outcomes, suggesting that the combined assessment of utDNA and ctDNA can provide comprehensive risk stratification for residual disease, aiding physicians in identifying patients who may require additional therapy.
See More
Natera Reports Record Q4 2025 Earnings with Strong Growth
- Significant Revenue Growth: Natera reported approximately $666 million in revenue for Q4 2025, reflecting a 40% increase year-over-year and exceeding expectations by $6 million, indicating strong market performance and sustained demand growth.
- Innovative Testing Volume: The company processed about 924,000 tests in Q4, with 225,000 MRD clinical units, marking a 56% increase from the previous year, which not only enhances market share but also strengthens its competitive position in precision medicine.
- Margin Improvement: Natera achieved a gross margin of 66.9%, with expectations to maintain margins between 63% and 65% in 2026, demonstrating ongoing improvements in cost control and operational efficiency that will support future profitability.
- Robust Cash Flow: The company generated over $100 million in cash flow for 2025, with a pristine balance sheet showing over $1 billion in cash and securities, reflecting a strong financial foundation to support future investments and growth.
See More
Natera (NTRA) Q4 2025 Earnings Call Transcript
See More
