Natera Inc Stock Price, News & Analysis

Natera (NASDAQ: NTRA) has secured national commercial coverage for its cfDNA Fetal RhD noninvasive prenatal test from one of the largest U.S. payors. The coverage, effective January 2025, will be available when pregnancies are at risk for alloimmunization, when paternal antigen typing is unavailable or heterozygous, and if amniocentesis is declined or not recommended.

The test, which can be performed as early as nine weeks into pregnancy, determines fetal RhD status from maternal blood samples. This is particularly significant as up to 15% of pregnant patients are RhD-negative. When a mother is RhD-negative and the fetus is RhD-positive, there's a risk of antibody development leading to hemolytic disease of the fetus and newborn.

The test is part of Natera's women's health product suite, which includes Panorama, the most ordered NIPT in the United States.

Natera (NTRA) announced significant results from two clinical trials in colorectal cancer (CRC). The Phase III CALGB/SWOG 80702 study, involving ~1,000 patients, demonstrated that Signatera-positive patients treated with both chemotherapy and celecoxib showed a 40% improvement in overall survival compared to chemotherapy alone.

Key findings revealed that adding celecoxib to standard chemotherapy significantly improved disease-free survival (DFS) in Signatera-positive patients, with a three-year DFS of 44.1% versus 26.6%. The study also confirmed Signatera's effectiveness in predicting recurrence.

Additionally, the ALTAIR clinical trial, studying 243 Signatera-positive patients, showed promising results for stage IV CRC patients treated with Trifluridine/Tipiracil (FTD/TPI). These patients demonstrated a median DFS of 9.76 months compared to 3.96 months in the placebo group, marking a significant advancement in personalized medicine for CRC treatment.

Natera Inc (NASDAQ: NTRA) announced multiple studies to be presented at the 2025 ASCO GI Symposium in San Francisco. Key highlights include data from the BESPOKE CRC study, the largest prospective MRD study in the U.S., which demonstrated Signatera's effectiveness as a prognostic and predictive biomarker in colorectal cancer patients.

The study showed that Signatera-positive patients had significantly inferior outcomes in both stage II (HR=10.4) and stage III patients (HR=10.1). The 24-month disease-free survival rates were 91.7% for Signatera-negative and 41.4% for Signatera-positive patients.

Additionally, Natera will present initial results from their novel tissue-free MRD detection test, showing high sensitivity and specificity, and early cancer detection data with 95% sensitivity and 91% specificity in colorectal cancer detection. The symposium will feature multiple presentations, including a late-breaking oral presentation on the CALGB/SWOG 80702 study.

Natera CEO Steve Chapman has received two significant recognitions in 2024: being named one of the top healthcare technology CEOs by Healthcare Technology Report and 'BioTechnology Innovator of the Year' by BioTech Breakthrough Awards. During his 15-year tenure at Natera, including serving as CEO since 2019, the company has published over 250 peer-reviewed papers and launched 20 products that have transformed patient care.

Under Chapman's leadership, Natera has developed key products including the Signatera™ oncology test, Prospera™ transplant assessment test, and Panorama™ non-invasive prenatal test. The Healthcare Technology Report's annual program recognizes the top 50 CEOs in biotechnology and life sciences, while the BioTech Breakthrough Awards received nominations from over 14 countries globally.

Natera (NASDAQ: NTRA) announced updates to its oncology innovation roadmap at the 43rd Annual J.P. Morgan Healthcare Conference. The company introduced three key developments:

1. A new version of Signatera leveraging whole genome sequencing (WGS), now available for research and clinical use, detecting down to low single-digit parts per million.

2. A novel tissue-free molecular residual disease (MRD) capability, with first launch expected in mid-2025 for colorectal cancer (CRC), utilizing methylation-based technologies.

3. Preliminary data for their Early Cancer Detection (ECD) assay, showing 92% detection of stage 1 CRC and 95% detection overall, with 91% specificity. The company plans to present additional data from the PROCEED-CRC cohort later this year, followed by an FDA-grade validation study if results are positive.

Natera (NTRA) has released preliminary unaudited results for Q4 and full-year 2024, showing significant growth across key metrics. The company expects Q4 2024 revenues of approximately $472 million, up 52% from Q4 2023, and full-year 2024 revenues of approximately $1.7 billion, representing a 56% increase from 2023.

Test volumes showed strong growth, with 792,800 tests processed in Q4 2024 (26.5% increase) and 3,064,600 tests for full-year 2024 (22.8% increase). Notably, oncology testing saw substantial growth, with 150,800 oncology tests in Q4 2024, marking a 54.7% increase. The company achieved positive cash inflows of $45.8 million in Q4 2024 and $86.3 million for full-year 2024, compared to previous year's cash outflows.

Natera (NASDAQ: NTRA), a leading cell-free DNA testing company, has announced its participation in the upcoming 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. The company's management team will deliver a presentation and conduct a Q&A session with investors on Wednesday, January 15, 2025, at 9:00 a.m. PT (12:00 p.m. ET).

Interested parties can access a live webcast of the event through the investor relations section of Natera's website at investor.natera.com. A recording of the presentation will be made available shortly after the conference concludes.

Natera (NASDAQ: NTRA) has expanded its patent infringement lawsuit against NeoGenomics by adding U.S. Patent No. 11,319,596 to the case. The District Court for the Middle District of North Carolina granted Natera's request on December 10, 2024. The amended complaint now includes both the '596 and previously asserted '454 patents, claiming infringement by NeoGenomics' modified RaDaR® test for molecular residual disease. This legal action follows earlier court decisions in December 2023 and September 2024 that resulted in preliminary and permanent injunctions against NeoGenomics' previous version of the RaDaR® test. Natera is pursuing full remedies, including injunctive relief, against NeoGenomics' current RaDaR® test offering.

Natera has announced the enrollment of the first patients in the SAGITTARIUS clinical trial, a phase III study aimed at using Signatera to guide personalized adjuvant treatment strategies for colon cancer. Sponsored by the AIRC Institute of Molecular Oncology and funded by the European Union Horizon Europe Programme, the study plans to enroll 700-900 patients across more than 20 sites. The trial will compare genotype-guided therapy versus standard chemotherapy for Signatera-positive patients and explore the use of immunotherapy and targeted agents earlier in the disease course. For Signatera-negative patients, the trial will assess treatments chosen by physicians, with options for observation or single-agent capecitabine. SAGITTARIUS involves collaborations with 9 partners in 5 European countries and a network of 26 clinical centers in Italy, Spain, and Germany. The trial aims to personalize treatment approaches and potentially reduce chemotherapy for certain patients.