Natera Submits PMA to FDA for Signatera CDx
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 6d ago
0mins
Should l Buy NTRA?
Natera announced the submission of its premarket approval, or PMA, to the FDA for Signatera CDx for detection of molecular residual disease, or MRD, in patients with muscle-invasive bladder cancer, or MIBC, who may benefit from treatment with atezolizumab, or Tecentriq. This submission is supported by data from the randomized, double-blind, phase 3 IMvigor011 clinical trial, which met its primary endpoint and demonstrated the benefits of Signatera-guided therapy in MIBC. In the study, Signatera-positive patients treated with atezolizumab had statistically significant and clinically meaningful improvements in disease-free survival and overall survival, compared with placebo. The trial also showed that Signatera-negative patients had a low risk of recurrence without adjuvant immunotherapy. Results were featured in a Presidential Symposium at the European Society for Medical Oncology Congress on October 20, 2025, with a concurrent publication in The New England Journal of Medicine. Bladder cancer is the sixth most common cancer in the U.S. and MIBC represents 20%-25% of the newly diagnosed cases.
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Analyst Views on NTRA
Wall Street analysts forecast NTRA stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for NTRA is 252.88 USD with a low forecast of 172.00 USD and a high forecast of 300.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
17 Analyst Rating
15 Buy
2 Hold
0 Sell
Strong Buy
Current: 197.080
Low
172.00
Averages
252.88
High
300.00
Current: 197.080
Low
172.00
Averages
252.88
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.
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- Large-Scale Study: Natera has launched the EDEN study, aiming to enroll 7,500 pregnant participants in the U.S. to evaluate its non-invasive prenatal screening test for early risk assessment of pregnancy complications, showcasing the company's proactive approach in prenatal care.
- High Incidence Focus: Preeclampsia affects approximately 5-8% of pregnancies and is a leading cause of maternal and neonatal morbidity; the EDEN study aims to provide scientific evidence to improve this situation, potentially driving demand for related medical services.
- Innovative Technology Application: The test integrates cell-free DNA and other clinical data to offer personalized risk assessments, surpassing traditional clinical characteristic evaluations, thereby enhancing the precision and effectiveness of prenatal care.
- Industry-Wide Impact: Through the EDEN study, Natera aims not only to enhance its market competitiveness but also to lead technological innovation in the prenatal screening sector, potentially elevating industry standards and development.
See More
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- Oversold Indicator: Natera Inc (Ticker: NTRA) hit an RSI of 27.8 during Wednesday's trading, indicating an oversold condition with a low of $204.86 per share, suggesting that recent heavy selling may be nearing exhaustion, prompting bullish investors to seek buying opportunities.
- Market Comparison: Compared to the S&P 500 ETF (SPY) with an RSI of 52.7, NTRA's oversold status may attract bullish investors' attention, especially given the overall stronger market performance.
- Historical Performance: NTRA shares have a 52-week low of $125.38 and a high of $256.36, with the last trade at $205.61, indicating potential price volatility that investors should monitor for rebound opportunities.
- Investor Sentiment: Despite the current low stock price, investor sentiment may shift to optimism due to the oversold signal, and if market sentiment improves, NTRA's stock price could rebound, further impacting the company's market performance.
See More
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- 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.
See More
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- Gene Editing Investments: The firm added 196K shares of Intellia Therapeutics and 49K shares of 10x Genomics, continuing to focus on next-generation sequencing and in vivo gene editing, aiming to capture innovative opportunities in the biotech sector.
- Autonomous Driving Focus: ARK invested in companies like WeRide and Pony AI in the autonomous driving and robotics space, reinforcing its strategic positioning in future transportation technologies, which is likely to enhance portfolio diversity and potential returns.
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- Multiple Companies Rated: Companies like Biogen (BIIB), Natera (NTRA), and Revolution Medicines (RVMD) also received D ratings, suggesting a notable decline in earnings expectations that could lead to stock price volatility.
- Market Impact: These ratings reflect a broader weakening of earnings momentum in the healthcare sector, potentially affecting the performance of related healthcare ETFs (such as XLV, VHT), prompting investors to reassess risks.
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