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First Commercial Brain Gene Therapy Treatments Delivered in US Using ClearPoint Neuro's SmartFlow Cannula

FDA ApprovalRare DiseaseNeurology
  • The first commercial gene therapy treatments ever delivered directly to the brain in the United States have been successfully performed using ClearPoint Neuro's SmartFlow Neuro Cannula to administer KEBILIDI for AADC deficiency.
  • KEBILIDI (eladocagene exuparvovec-tneq) is delivered directly to the putamen region of the brain through stereotactic neurosurgery, with the SmartFlow cannula being the only FDA-authorized device for this administration.
  • ClearPoint Neuro reported record clinical activity in July with 17 global patients treated across 11 different drug platforms, while nine of the company's partners have now been accepted into FDA expedited review programs.
  • New ICD-10 codes specific to neuro infusions will become effective October 1, 2025, to assist in tracking commercial use of brain-delivered therapies.

TransMedics Receives FDA Approval for Largest Heart Transplant Preservation Trial

FDA Approval
  • TransMedics received FDA conditional approval for its Investigational Device Exemption to initiate the Next-Generation OCS ENHANCE Heart trial, marking a significant regulatory milestone.
  • The two-part ENHANCE trial will exceed 650 patients and aims to demonstrate superiority of OCS Heart perfusion over static cold storage methods in donation after brain death cases.
  • The company plans to initiate both the ENHANCE Heart and DENOVO Lung trials in Q4 2025, positioning these studies as major catalysts for clinical adoption throughout 2026.
  • TransMedics believes this will constitute the largest heart preservation for transplant trial ever conducted worldwide, addressing critical unmet needs in cardiothoracic transplantation.

Anbogen Receives FDA Clearance for Phase 1/2 Trial of ABT-301 Triplet Therapy in Metastatic Colorectal Cancer

FDA Approval
  • Anbogen Therapeutics received FDA approval for its Investigational New Drug application to initiate a Phase 1/2 clinical trial of ABT-301 combined with tislelizumab and bevacizumab for metastatic colorectal cancer patients.
  • The open-label, multi-center international study will enroll 66 patients with proficient mismatch repair or non-microsatellite instability-high metastatic colorectal cancer in Taiwan and Australia.
  • ABT-301 is an oral HDAC1/2/3 inhibitor that converts "cold tumors" into "hot tumors" by promoting CD8+ T cell infiltration and enhancing immune checkpoint inhibitor efficacy.
  • The therapy targets approximately 95% of metastatic colorectal cancer patients who respond poorly to current immunotherapies, representing a potential $9 billion market opportunity.

Dose-Seeking Study of MPT0E028 in Subjects With Advanced Solid Malignancies Without Standard Treatment

NCT02350868CompletedPhase 1
Taipei Medical University
Posted 4/24/2015

MAGENTIQ EYE Secures Series A Funding to Advance AI-Powered Colonoscopy Technology

AIFDA Approval
  • MAGENTIQ EYE completed its Series A funding round led by aMoon to accelerate commercialization of its FDA- and CE-approved AI colonoscopy software MAGENTIQ-COLO in the USA and Europe.
  • The company's AI-powered software significantly improves adenoma detection rates during colonoscopies and offers real-time polyp analysis with size and type estimation capabilities.
  • Funding will support ongoing clinical trials for diagnostic tools targeting ulcerative colitis, Barrett's esophagus dysplasia, and gastric intestinal metaplasia while expanding global market access.
  • The investment reflects growing commercial traction with dozens of daily procedures and a robust pipeline of trial and purchase requests across international markets.

Alphamab Oncology's HER2-Targeting ADC JSKN003 Receives FDA Orphan Drug Designation for Gastric Cancer

FDA Approval
  • Alphamab Oncology's anti-HER2 biparatopic antibody-drug conjugate JSKN003 has been granted FDA Orphan Drug Designation for treating gastric cancer and gastroesophageal junction cancer.
  • The designation provides significant regulatory advantages including tax credits, fee waivers, accelerated review processes, and potential seven-year market exclusivity upon approval.
  • JSKN003 demonstrated favorable safety and promising efficacy in Phase I clinical studies, particularly in heavily pretreated patients with high HER2-expressing gastrointestinal tumors.
  • Gastric and gastroesophageal junction cancers represent a significant unmet medical need with poor survival outcomes, affecting approximately 960,000 new cases globally and 26,890 cases in the U.S. annually.

First-In-Human Study in Subjects With Advanced or Metastatic Solid Malignant Tumors

NCT05494918CompletedPhase 1
Alphamab (Australia) Co Pty Ltd.
Posted 9/2/2022

Safety and Tolerability of JSKN003 in Chinese Subjects With Advanced Solid Tumors

NCT05744427Active, Not RecruitingPhase 1
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Posted 3/15/2023

Rigicon Initiates AUSOME Study for Artificial Urinary Sphincter FDA Approval

FDA Approval
  • Rigicon has begun patient enrollment in the AUSOME Study, a pivotal clinical investigation designed to support FDA Premarket Approval for its artificial urinary sphincter technology.
  • The first two patients were enrolled in the UK under the leadership of Dr. Rowland Rees, with the study evaluating safety, effectiveness, and patient-reported outcomes.
  • The company plans to expand enrollment across global urology centers and is developing additional product lines including electronic artificial urinary sphincter and penile prostheses.
  • Rigicon's device offers advancements in patient comfort, usability, and durability compared to existing artificial urinary sphincter solutions on the market.

Viatris Wins Patent Battle Against Novo Nordisk Over Generic Wegovy

FDA Approval
  • A federal district court in Delaware ruled that Viatris' generic version of Wegovy does not infringe on Novo Nordisk's patent for the GLP-1 receptor agonist semaglutide.
  • The court determined that Viatris' product label does not encourage use without other therapeutic agents, which was a key limitation in Novo Nordisk's patent claim.
  • This victory removes one patent obstacle for Viatris' generic Wegovy, which is currently awaiting FDA approval, while the global Wegovy market reached $8.4 billion in 2024.
  • The ruling comes amid ongoing patent disputes in the lucrative obesity drug market, with GlobalData forecasting the obesity market to exceed $173.5 billion by 2031.

FDA Rejects Replimune's Melanoma Drug Amid Evolving Regulatory Standards

FDA ApprovalOncology
  • The FDA rejected Replimune's melanoma drug in a complete response letter, citing inadequate single-arm study design and patient enrollment differences as key concerns.
  • The agency questioned whether the single-arm study provided substantial evidence of effectiveness and raised issues with the company's confirmatory trial design.
  • Analysts interpret the rejection as evidence of changing FDA approval standards, with Replimune CEO expressing surprise at the decision given prior agency meetings.
  • The rejection highlights the evolving regulatory landscape for oncology drug approvals, particularly for single-arm studies in melanoma treatment.

Nestmedic Partners with Curavit for U.S. Clinical Trial of AI-Enabled Prenatal Monitoring Device

AIFDA Approval
  • Nestmedic S.A. has selected Curavit Clinical Research to lead the U.S. clinical trial of PregnaOne, an AI-enabled remote prenatal monitoring solution designed to provide continuous insight into fetal and maternal well-being.
  • The FDA-required Non-Significant Risk study will enroll 50 expectant mothers across multiple U.S. sites over 11 months to evaluate the safety and effectiveness of home-based prenatal monitoring.
  • The trial aims to generate foundational evidence to support future regulatory approval in the U.S., with Curavit managing all aspects including IRB submissions, site selection, data management, and clinical study reporting.

MVP Health Care Partners with Renalytix to Expand Access to AI-Powered Kidney Disease Testing

AIPrecision MedicineFDA Approval
  • MVP Health Care and Renalytix announced a partnership to expand access to the FDA-approved kidneyintelX.dkd test for patients with type 2 diabetes and chronic kidney disease.
  • The collaboration aims to identify patients at higher risk for progressive kidney function decline earlier, enabling more targeted therapeutic interventions and personalized care plans.
  • The test will be available to all MVP customers in New York, including Medicare and Medicaid beneficiaries, and is recommended by KDIGO clinical guidelines.
  • Renalytix reports measurable improvements in patient outcomes and quality metrics, including HEDIS measures for blood pressure and HbA1c control in high-risk populations where the test is implemented.

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