Natera Announces Publication of Signatera™ Analysis from Randomized, Phase III CALGB (Alliance)/SWOG 80702 Study in Colorectal Cancer

On December 18, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported the publication of findings from the randomized, phase III CALGB (Alliance)/SWOG 80702 study in JAMA Oncology. This publication builds on the initial presentation of results at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Gastrointestinal Cancers Symposium (ASCO GI) earlier this year.

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CALGB (Alliance)/SWOG 80702 assessed the predictive value of postoperative personalized circulating tumor DNA (ctDNA) in patients with stage III colorectal cancer (CRC). The pre-specified post-hoc analysis included 940 patients with available post-surgical plasma samples, who were randomized to receive FOLFOX +/- celecoxib, a non-steroidal anti-inflammatory drug (NSAID). Key findings included:

Adding celecoxib to conventional chemotherapy in Signatera-positive patients, after surgery reduced the risk of cancer recurrence and death by ~40%. Celecoxib improved disease-free survival (DFS) (adjusted HR=0.61, 95% CI 0.42-0.89; 3-year 41.0% vs. 22.6%) and overall survival (OS) (adjusted HR=0.62, 95% CI 0.40-0.96; 5-year: 61.6% vs. 39.9%) compared to placebo in Signatera-positive patients.
Celecoxib benefit in Signatera-positive patients was independent of demographic, pathologic or molecular factors, including PIK3CA status, further defining a patient population who may benefit from the addition to adjuvant treatment. Celecoxib improved DFS of Signatera-positive patients for both PIK3CA wild-type (adjusted HR=0.64, 95% CI 0.42-0.98) and PIK3CA altered (adjusted HR=0.19, 95% CI 0.06-0.58) tumors. No benefit was observed in Signatera-negative patients (PIK3CA wild-type adjusted HR=0.80, 95% CI 0.55-1.18; PIK3CA altered HR=0.85, 95% CI 0.33-2.24).
New analysis showed statistical significance in the interaction between MRD status and treatment randomization. In 66% of patients with plasma and DNA samples that would pass minimum QC criteria for Signatera analysis in the CLIA lab, analysis showed an even stronger benefit for adjuvant celecoxib than in the overall cohort (adjusted HR=0.49); and it showed significance in the statistical interaction test comparing the effect of celecoxib vs. placebo between patients who were Signatera positive vs. negative. In Natera’s standard lab practice, 99% of plasma and DNA samples meet QC criteria.
"For patients with detectable ctDNA after surgery, adding celecoxib to standard chemotherapy improved both DFS and OS," said Jonathan Nowak, M.D., Ph.D., Brigham and Women’s Hospital, and corresponding author of the publication. "In addition to highlighting Signatera’s predictive abilities in this setting, the publication also underscores its value as a prognostic marker for disease recurrence and survival."

"This publication marks another important milestone in colorectal cancer research, highlighting Signatera as a critical tool in disease management," said Adham Jurdi, M.D., senior medical director of GI oncology at Natera. "It further demonstrates Signatera’s predictive utility in identifying, with great precision, patients with MRD who will likely benefit from celecoxib in addition to chemotherapy, regardless of their PIK3CA status."

(Press release, Natera, DEC 18, 2025, View Source [SID1234661549])

Incyte to Present at Upcoming Investor Conference

On December 18, 2025 Incyte (Nasdaq:INCY) reported that it will present at the 44th Annual J. P. Morgan Healthcare Conference on Monday, January 12, 2026 at 8:15 am (PST).

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The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 30 days.

(Press release, Incyte, DEC 18, 2025, View Source [SID1234661548])

New Publication Shows PROSTOX™ ultra Test Delivers Significant Health System Cost Savings and Quality-of-Life Gains for Prostate Cancer Patients Undergoing Radiation Therapy

On December 18, 2025 MiraDx, a molecular diagnostics company focused on germline genetic testing to personalize cancer treatment, reported a new analysis has been published in the Journal of Health Economics and Outcomes Research demonstrating that the PROSTOX ultra test can deliver substantial long-term economic and quality-of-life benefits for patients and the healthcare system.

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PROSTOX ultra is a clinically validated germline genetic test for men with localized prostate cancer considering stereotactic body radiation therapy (SBRT), a treatment that delivers high doses of radiation over a short time period, with 5-7 treatments. The test identifies patients at higher risk of developing late genitourinary (GU) toxicity—urinary side effects such as urgency, leakage, or discomfort that may occur after treatment. While SBRT is a very effective and convenient treatment for prostate cancer, a subset of patients experience urinary side effects that present months or even years after treatment and can persist throughout the patient’s lifetime. By identifying patients with increased risk of these side effects from SBRT, PROSTOX ultra helps doctors and patients make more informed treatment decisions and consider alternative options when needed.

The study, which modeled clinical pathways incorporating PROSTOX ultra versus treatment guided by the current standard of care for patients receiving treatment for localized prostate cancer, found a significant cost savings of $19,615 per tested patient. Over a lifetime, the benefits grow even larger. The analysis showed that each patient tested with PROSTOX ultra is expected to save the health care system approximately $24,777 over the patient’s lifetime, while also gaining 0.24 additional quality-adjusted life years (QALYs) compared to patients evaluated without genetic risk assessment.

The publication, "Economic Evaluation of a Novel MicroRNA-Based Assay to Determine Risk of Late Genitourinary Radiation Toxicity in Patients With Prostate Cancer," can be viewed in its entirety by visiting the Journal of Health Economics and Outcomes Research website here: View Source

"Physicians in practice using PROSTOX ultra are seeing its benefits in helping their patients avoid late GU toxicity from SBRT. These new results also now show that PROSTOX ultra meaningfully reduces the long-term cost burden on the healthcare system," said Melissa Stoppler, MD, Executive Vice President of Medical Affairs at MiraDx. "This new evidence further validates the value of integrating the test into treatment considerations for localized prostate cancer."

(Press release, MiraDx, DEC 18, 2025, View Source [SID1234661547])

Syneron Bio Closes Nearly $100M in Series A and A+ Rounds

On December 18, 2025 Syneron Bio, an macrocyclic peptide drug discovery company driven by intelligent high-throughput platform, reported it has successfully completed its Series A and A+ financing rounds, raising close to USD 100 million in total. Top-tier investors participated in the round, including AstraZeneca, AZ-CICC Healthcare Investment Fund, Pfizer Biotech Development Investment Fund, GL Ventures, 5Y Capital, Sinovation Capital, Lenovo Capital, Gree Capital and KHK fund.

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Dr. Xiao Zhang, Founder and CEO of Syneron Bio, commented:
"We are honored to receive the recognition and support of leading global pharmaceutical companies and top-tier investment institutions. This financing will significantly strengthen the development of our intelligent high-throughput macrocyclic peptide development platform, Synova, and provide the resources needed to advance multiple pipelines toward clinical stages."

(Press release, Syneron Tech, DEC 18, 2025, View Source [SID1234661546])

Curasight Announces Successful Dosing of First Patient in Phase 1 trial with uTREAT® in Brain Cancer

On December 18, 2025 Curasight A/S ("Curasight" or "the Company" – TICKER: CURAS) reported the successful and safe dosing of the first patient in the Phase 1 trial using uTREAT in brain cancer (high grade gliomas). The news marks the initiation of the first clinical trial under the company’s therapeutic platform uTREAT, investigating it as a potential treatment option for glioblastoma.

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The start of the phase 1 study with uTREAT means that Curasight is now in the clinical phase with both parts of its theranostic platform aimed at improving treatment and diagnosis of certain cancers. The company’s diagnostic platform uTRACE is currently in a Phase 2 trial for prostate cancer under the strategic partnership with Curium Inc.

"The dosing of the first patient with uTREAT in this Phase 1 trial marks an important step in the development of the therapeutic arm of our theranostic platform, making Curasight a clinical stage therapeutic company". Said Curasight’s CEO Ulrich Krasilnikoff. "I very much look forward to seeing the data and would like to take this opportunity to thank the patient and doctors involved in this trial in supporting our efforts to develop uTREAT ".

About the Phase 1 trial with uTREAT in brain cancer

The trial aims to investigate Curasight’s uTREAT as a new type of targeted radiopharmaceutical therapy in glioblastoma patients. Participants in the trial are patients with newly diagnosed verified or suspected GBM. The trial design is informed from research and earlier studies with uTRACE as well as protocol discussions with Key Opinion Leaders.

About the uPAR theranostic platform

Curasight’s uPAR theranostic platform combines two key technologies – uTRACE and uTREAT both targeting the uPAR receptor. uTRACE is designed to deliver sensitive imaging for diagnosis, while uTREAT offers a targeted radiopharmaceutical solution. Together, they form an integrated approach to improving the diagnosis and treatment of cancers that express uPAR. Curasight’s ambition is to develop both uTRACE and uTREAT to improve diagnosis and treatment of uPAR-expressing cancers.

About high grade glioma

Treatment of glioblastoma and other high-grade gliomas (WHO grades 3 or 4) presents a significant unmet medical need, necessitating innovative and effective treatments. A total of approx. 65,000 patients are diagnosed with primary brain tumors and more than 30,000 patients are diagnosed annually with the most aggressive form, glioblastoma, in the US and EU. Approximately 10 % of the patients are children. The prognosis for individuals with glioblastoma is very poor as approximately 50% of the patients die within 14 months and after five years from diagnosis only 5% are still alive. External beam radiation is a cornerstone in the therapy of brain cancers. uTREAT could potentially replace or reduce the use of external beam radiation and thereby lower side effects to the healthy brain due to more specific tumor tissue targeting.

(Press release, Curasight, DEC 18, 2025, View Source [SID1234661545])