MedPath

Clinical Trial News

VarmX Receives FDA Fast Track Designation for VMX-C001 Anticoagulant Reversal Therapy

  • VarmX received FDA fast track designation for VMX-C001, an investigational therapy designed to bypass Factor Xa direct oral anticoagulants in emergency surgical settings.
  • The designation follows FDA clearance of an investigational new drug application in July 2025, enabling launch of the pivotal Phase III EquilibriX-S trial.
  • VMX-C001 is a modified human factor X protein engineered to restore coagulation rapidly without increasing thrombotic risk or requiring specific dosing based on anticoagulant type.
  • By 2030, approximately 30 million patients in the US, Europe, and Japan are projected to be on FXa DOACs, with over 25,000 weekly emergency cases requiring intervention.

Mendaera's Focalist Handheld Robotic System Receives FDA Clearance for Ultrasound-Guided Procedures

  • Mendaera received FDA 510(k) clearance for its Focalist handheld robotic system designed to enhance precision in ultrasound-guided needle placement procedures.
  • The system integrates handheld robotics, real-time ultrasound imaging, and advanced software with touchscreen targeting and continuous needle depth tracking capabilities.
  • Initial limited launch begins in 2025 focusing on urology procedures like percutaneous nephrolithotomy, with full commercialization expected in 2026.
  • The technology addresses the challenge of operator-dependent variability in image-guided procedures that affect hundreds of millions of patient encounters globally each year.

Caris Life Sciences Validates AI-Powered Blood Test for Multi-Cancer Detection and Monitoring

AIPrecision Medicine
  • Caris Life Sciences published a landmark study in Scientific Reports validating the Caris Assure blood-based biopsy assay, which combines comprehensive molecular profiling of all 23,000+ genes across DNA and RNA in plasma.
  • The AI-powered platform achieved sensitivities of 83.1% to 95.7% across cancer stages I-IV at 99.6% specificity for multi-cancer early detection, trained on over 376,000 tissue profiles.
  • The assay demonstrated significant predictive power for recurrence monitoring with hazard ratios of 33.4 for minimal residual disease and 4.39 for therapeutic monitoring.
  • While currently available for therapy selection in advanced cancers, Caris is pursuing regulatory pathways to expand into early detection and disease monitoring applications.

Insightec Receives FDA Approval for Bilateral Focused Ultrasound Treatment in Advanced Parkinson's Disease

Drug Approval
  • The FDA has approved Insightec's Exablate Neuro platform for staged bilateral pallidothalamic tractotomy treatment in patients with advanced Parkinson's disease, expanding therapeutic options for over 50,000 patients.
  • The incisionless procedure uses MRI-guided focused ultrasound to precisely target brain areas without requiring implanted hardware, offering a lower risk profile compared to traditional surgical interventions.
  • Clinical trials conducted at nine centers across the U.S., Europe, and Asia demonstrated encouraging outcomes supporting FDA approval, with full results expected to be published later this year.
  • Insightec plans a limited launch of the bilateral procedure in select centers during 2025, with ongoing efforts to establish routine reimbursement pathways for broader patient access.

Evaluation of the Safety and Effectiveness of Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD)

NCT04728295Active, Not RecruitingNot Applicable
InSightec
Posted 5/14/2021

Verified Clinical Trials Launches Advanced Subject Registry Platform in Japan to Combat Duplicate Trial Participants

  • Verified Clinical Trials has officially launched operations in Japan through partnerships with Medical Revolutions Japan and JACIC to address the growing challenge of duplicate research subjects in clinical trials.
  • The VCT platform replaces Japan's 30-year-old system that was limited to Phase 1 studies, extending protection across Phase I through Phase IV trials with advanced biometric capabilities.
  • The global registry system, already deployed in up to 40 countries, provides real-time detection and prevention of duplicate subjects and protocol violations during screening and throughout trial duration.

Dual-Payload ADCs Enter Clinical Testing as Innovent and Chengdu Kanghong Pioneer Next-Generation Cancer Therapeutics

Oncology
  • Innovent's IBI3020, a dual-payload ADC targeting CEACAM5, has begun first-in-human trials for solid tumors, marking a significant milestone in next-generation cancer therapeutics.
  • The dual-payload ADC field has rapidly expanded with two clinical-stage assets now in development, positioning these companies ahead of traditional single-payload approaches.
  • Chengdu Kanghong's TROP2-targeting KH815 was initially planned to be the first dual-payload ADC in clinical trials but has yet to begin patient recruitment despite regulatory approval.
  • Multiple companies are pursuing dual-payload ADC strategies based on the hypothesis that two different warheads may provide superior therapeutic outcomes compared to single-payload designs.

Anthem Biosciences Launches ₹3,395 Crore IPO as Contract Research Organization Targets Public Markets

  • Anthem Biosciences, a Contract Research, Development, and Manufacturing Organization (CRDMO), is launching a ₹3,395 crore IPO from July 14-16 with shares priced at ₹540-570 each.
  • The company reported strong financial performance with revenue growing 30% year-on-year to ₹1,844 crore in FY25 and profit after tax increasing 23% to ₹451 crore.
  • The IPO is entirely an offer for sale by existing shareholders, meaning no proceeds will go to the company for expansion or operations.
  • Anthem operates integrated pharmaceutical services from drug discovery to manufacturing, specializing in complex fermentation-based APIs including probiotics, enzymes, and biosimilars.

Simcere Submits New Drug Application for Rademikibart in China's 70 Million Patient Atopic Dermatitis Market

Monoclonal Antibody
  • Simcere Pharmaceutical has submitted a New Drug Application to China's NMPA for rademikibart, targeting atopic dermatitis treatment in adults and adolescents.
  • The IL-4Rα-targeting monoclonal antibody addresses China's substantial atopic dermatitis market, estimated at 70 million patients.
  • Connect Biopharma stands to receive up to $110 million in milestone payments and tiered royalties from the exclusive licensing agreement established in 2023.

Sarilumab Combination Achieves 63.6% Response Rate in Advanced Melanoma Phase 2 Trial

  • A phase 2 study demonstrated that adding sarilumab to ipilimumab, nivolumab, and relatlimab achieved a 63.6% overall response rate in patients with unresectable stage III or IV melanoma.
  • The combination showed one of the highest response rates observed in melanoma checkpoint inhibitor studies to date, with a 78.8% clinical benefit rate at 24 weeks.
  • Grade 3/4 immune-related adverse events occurred in only 12.1% of patients, significantly lower than comparable studies using anti-CTLA-4 regimens.
  • The IL-6 receptor blocking approach appears to enhance efficacy while reducing toxicity compared to existing checkpoint inhibitor combinations.

Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma

NCT05428007RecruitingPhase 2
NYU Langone Health
Posted 12/16/2022

Johnson & Johnson Submits FDA Application for CAPLYTA Schizophrenia Relapse Prevention Based on 63% Risk Reduction Data

Drug Approval
  • Johnson & Johnson submitted a supplemental New Drug Application to the FDA for CAPLYTA (lumateperone) for schizophrenia relapse prevention based on Phase 3 data showing 63% reduction in relapse risk versus placebo.
  • The multicenter, double-blind trial demonstrated significantly longer time to relapse during 26-week treatment phase (p=0.0002) and delayed time to all-cause discontinuation (p=0.0007).
  • CAPLYTA is already FDA-approved for schizophrenia treatment and bipolar depression, with this expansion potentially addressing a critical unmet need in long-term schizophrenia management.
  • The safety profile remained consistent with existing clinical data, with headache being the most commonly reported adverse event at rates exceeding placebo.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.