Natera Inc Stock Price, News & Analysis

Natera (NASDAQ: NTRA) announced publication in JAMA Oncology of a randomized phase III CALGB (Alliance)/SWOG 80702 analysis of Signatera ctDNA in stage III colorectal cancer (940 patients with post-surgical plasma). Key findings: in Signatera-positive patients, adding celecoxib to FOLFOX lowered recurrence and death risk by ~40% (DFS adjusted HR=0.61; OS adjusted HR=0.62) with 3-year DFS 41.0% vs 22.6% and 5-year OS 61.6% vs 39.9%. No significant benefit was seen in Signatera-negative patients. A QC-restricted subgroup (66%) showed stronger benefit (adjusted HR=0.49); Natera reports 99% routine QC pass rate.

Natera (NASDAQ: NTRA) and collaborators published I‑SPY 2 results in Nature Communications showing Signatera personalized ctDNA testing can refine risk stratification in 723 women with high‑risk, early‑stage breast cancer treated with neoadjuvant therapy (NAT).

Key findings: Signatera improved prognostic precision beyond residual cancer burden (RCB) for RCB‑II/III patients; post‑NAT ctDNA– patients had substantially higher 3‑year distant recurrence‑free survival (e.g., RCB‑II T3 88% vs 57%; RCB‑III T3 83% vs 22% for ctDNA– vs ctDNA+). Persistent post‑NAT ctDNA+ predicted recurrence (adjusted HR 5.20, p < 0.001). Median assay variant conservation was 94–97% between pretreatment and post‑NAT samples.

Natera (NASDAQ: NTRA) and MEDSIR announced the MiRaDoR phase II multicenter trial (NCT05708235) testing Signatera Genome‑guided interventions in early‑stage HR+/HER2‑ breast cancer.

Up to 60 Signatera‑positive patients without radiologic recurrence will be sequentially assigned to four arms: standard endocrine therapy (90 days) then switch to Arm B giredestrant, Arm C giredestrant+abemaciclib, or Arm D giredestrant+inavolisib for PIK3CA‑mutant patients. Primary endpoint: proportion with ≥90% ctDNA decrease/clearance at 3 months. Enrollment is underway with UK sites active and further European activations expected in 2026.

Natera (NASDAQ: NTRA) reported initial translational results from the Phase III PALLAS trial showing that Signatera MRD testing after surgery strongly stratifies distant recurrence risk in stage II–III HR+/HER2- breast cancer.

In a U.S. biomarker cohort of 420 patients, ~92% were MRD-negative at baseline with a 5-year DRFI of 93%, while baseline MRD-positive (~8%) had a 5-year DRFI of 28% (HR ~15). At end of treatment, MRD-negative 5-year DRFI was 95% and MRD-positive 32% (HRs >20). MRD status at baseline, ~6 months, and EOT was consistently highly prognostic versus clinicopathologic factors.

Natera (NASDAQ: NTRA) presented two oral analyses at the ASH Annual Meeting showing clinical utility of personalized ctDNA testing in lymphoma.

Key highlights: Signatera detected ctDNA pre-treatment in 94% of 144 patients across 14 lymphoma subtypes and showed ctDNA clearance strongly predicted CAR-T response (p=0.0028); rapid clearance after one chemotherapy cycle had HR 20.95 versus 7.45 for delayed clearance. Signatera end-of-1L status was highly prognostic for event-free survival (HR 49.77, p<0.0001). The HOVON study using CLARITY (166 DLBCL patients) found post-negative surveillance relapse-free probability of 99% at 6 months and 97% at 12 months.

Natera (NASDAQ: NTRA) completed an all-stock acquisition of Foresight Diagnostics to expand its personalized MRD offerings and lymphoma capabilities. The deal values Foresight at up to $450 million ( $275M upfront plus $175M in earnouts tied to revenue and reimbursement milestones). Foresight’s PhasED-Seq phased-variant technology reports LOD95 of 0.3 ppm and detection below 0.1 ppm, and the technology will be integrated into Natera’s Signatera platform for research use immediately and for clinical launch in 2026. Foresight CLARITY MRD assay and recent inclusion of ctDNA MRD in NCCN lymphoma guidance support clinical momentum.

Natera (NASDAQ: NTRA) will present new Signatera data at the 2025 American Society of Hematology (ASH) Annual Meeting, December 6-9 in Orlando. Four abstracts report Signatera clinical validity and utility in hematologic malignancies, including a retrospective real-world cohort of 144 lymphoma patients showing personalized ctDNA predicted outcomes, detected recurrence earlier than imaging, and clarified ambiguous scans.

Presentations also cover ctDNA MRD monitoring after autologous transplant in multiple myeloma and WGS/WES-based ctDNA methods for DLBCL molecular subtyping. One oral talk is Dec 6 at 2:45 PM ET.

Natera (NASDAQ: NTRA) will present at the 2025 San Antonio Breast Cancer Symposium (Dec 9–12) with at least 12 abstracts covering Signatera results from >50,000 patients across real-world and prospective studies.

Key disclosed findings include a Signatera Genome surveillance cohort (n=227) with reported 100% sensitivity and specificity for detecting recurrence, aSignatera-positive within 3 months post-surgery associated with higher distant recurrence risk (HR 13.1, 95% CI 1.4–122.1, P=0.005), and Signatera positivity post-treatment linked to worse distant recurrence-free survival (HR 221.2, 95% CI 131.0–373.4, P <0.0001). LEADER phase 2 data show sustained MRD negativity with 12-month NPV RFS=99% and DRFS=100% and delayed distant recurrence for MRD-positive patients treated with ribociclib (18.6 vs 5.4 from treatment start).

Natera (NASDAQ: NTRA) reported that employees contributed more than 1,500 volunteer hours during its fourth annual Volunteer Month in October, organized by employee group Natera Nurtures.

Key activities included sorting 5,600+ pounds of food (equivalent to 4,725 meals) in Austin, serving 120 Ronald McDonald House guests in the Bay Area, 50+ volunteers making fleece blankets in San Carlos and Pleasanton, blood donations helping 100+ patients, care-kit assemblies, animal-shelter support, and community cleanups.

Since 2021, employees have logged 28,500+ volunteer hours, surpassing the company’s five-year target of 20,000 hours by end of 2025.