MedPath

Tagged News

Medtronic Initiates PELE Clinical Trial for Onyx Liquid Embolic System in Peripheral Arterial Hemorrhage

FDA Approval
  • Medtronic has enrolled the first patient in the PELE clinical trial to evaluate the Onyx Liquid Embolic System for treating arterial hemorrhage in peripheral vasculature.
  • The pivotal study will enroll up to 119 patients across 25 U.S. sites to assess safety and effectiveness through 30 days post-treatment.
  • The trial aims to provide evidence for U.S. regulatory approval, as Onyx LES is already available with peripheral indications in many international markets.
  • The first procedure was successfully performed by Dr. Christopher Stark at Albany Medical Center for a patient with bleeding from a ruptured blood vessel.

Iovance Biotherapeutics Recruits Former FDA Oncology Leader Marc Theoret as Senior VP of Regulatory Strategy

FDA Approval
  • Iovance Biotherapeutics has appointed Marc R. Theoret, M.D., former FDA Deputy Center Director, to the newly created position of Senior Vice President, Regulatory Strategy.
  • Dr. Theoret brings over 15 years of FDA experience, including five years as Deputy Center Director of the Oncology Center of Excellence and leadership in regulatory reviews for hematological malignancies and solid tumors.
  • The appointment strengthens Iovance's regulatory capabilities as the company advances its tumor infiltrating lymphocyte (TIL) therapy pipeline across multiple solid tumor cancers.
  • Iovance's Amtagvi represents the first FDA-approved T cell therapy for a solid tumor indication, positioning the company as a leader in the TIL therapy space.

Neurizon Receives FDA Approval for Strategy to Lift Clinical Hold on ALS Drug NUZ-001

FDA Approval
  • Neurizon Therapeutics received written FDA confirmation accepting its strategy to lift the clinical hold on NUZ-001, an investigational treatment for amyotrophic lateral sclerosis (ALS).
  • The company has completed two required preclinical pharmacokinetic studies ahead of schedule to address FDA concerns about systemic exposure data.
  • Neurizon anticipates submitting its complete response to the FDA in the coming weeks and expects the clinical hold to be lifted by August 2025.
  • The regulatory progress positions NUZ-001 for entry into the HEALEY ALS Platform Trial in the second half of 2025.

Formycon Completes Enrollment for Keytruda Biosimilar Study, Skips Phase III Trial with FDA Approval

FDA ApprovalOncology
  • Formycon AG successfully completed patient enrollment for its Dahlia pharmacokinetic study with 96 participants, comparing biosimilar candidate FYB206 to Keytruda in melanoma patients.
  • The FDA approved a streamlined clinical development program allowing Formycon to skip the Phase III trial, accelerating development and reducing costs significantly.
  • Results from the primary endpoint are expected in Q1 2026, with potential market entry after Keytruda's exclusivity expires in 2029 for the US and 2030 for the EU.
  • The development targets the world's best-selling drug with $29.5 billion in 2024 sales, potentially reaching over $50 billion by 2032.

Imagion Biosystems Receives FDA Fast-Track Approval for MagSense HER2 Breast Cancer Imaging Agent

FDA Approval
  • Imagion Biosystems has received FDA fast-track approval for its MagSense HER2 imaging agent ahead of a Phase 2 breast cancer trial scheduled for this year.
  • The FDA provided positive feedback and constructive input regarding the study plan after detailed discussions with Imagion's clinical team, with no issues identified that could negatively impact future clinical and commercial development.
  • The multi-site open-label Phase 2 trial will be led by Dr. William Dooley from the University of Oklahoma Health Sciences College of Medicine to optimize dosing and imaging protocols for diagnostic performance.
  • The company expects to complete final manufacturing and testing steps by the end of September and file the Investigational New Drug (IND) application in the third quarter of 2025.

Neuros Medical Secures $56 Million Series D to Commercialize FDA-Approved Post-Amputation Pain Treatment

FDA Approval
  • EQT Life Sciences co-led a $56 million Series D financing round for Neuros Medical to support U.S. commercialization of Altius®, an FDA-approved direct electrical nerve stimulation system.
  • Post-amputation pain affects up to 80% of amputees in the U.S., representing a severely underserved indication with few effective non-opioid treatment options available.
  • Altius® is currently the only FDA-approved solution for post-amputation pain, delivering targeted nerve stimulation through patient-controlled, on-demand therapy.
  • The oversubscribed funding round will enable Neuros Medical to scale commercial operations and expand access to this breakthrough non-opioid treatment for amputees.

Venture Medical Leads €6 Million Investment in Cold Plasma Wound Therapy Developer Plasmacure

FDA Approval
  • Venture Medical leads a €6 million Series A funding round for Dutch MedTech company Plasmacure, developer of PLASOMA cold plasma therapy for chronic wound healing.
  • PLASOMA demonstrated 2.5 times more wound closure than current standards of care in recent clinical trials, targeting diabetic foot ulcers and other hard-to-heal wounds.
  • The investment includes over $10 million in additional commitments to support FDA regulatory approval and U.S. market expansion for the breakthrough technology.
  • Cold plasma therapy offers antimicrobial effects while promoting tissue regeneration, addressing the growing burden of chronic wounds that lead to amputations and sepsis.

CorFlow Therapeutics Receives FDA Approval for MOCA-II Pivotal Trial Testing Novel Heart Attack Diagnostic Technology

FDA Approval
  • CorFlow Therapeutics received FDA investigational device exemption approval for its MOCA-II pivotal trial, enabling enrollment of over 200 STEMI patients at U.S. and European research institutions.
  • The trial will validate the diagnostic accuracy of CorFlow's CoFl system in detecting microvascular obstruction during primary PCI procedures, comparing results to cardiac MRI reference standards.
  • More than half of STEMI heart attack patients have microvascular obstruction, which drives adverse clinical outcomes, yet no approved diagnostic technologies currently exist for real-time detection during interventions.
  • The technology represents a potential breakthrough in heart attack care, as someone experiences a heart attack every 30 seconds in the U.S. with approximately 800,000 cases annually.

Gallant Raises $18M to Develop First FDA-Approved Off-the-Shelf Stem Cell Therapy for Pets

FDA Approval
  • San Diego startup Gallant has secured $18 million in Series A funding to advance the first FDA-approved ready-to-use stem cell therapy for veterinary medicine.
  • The company's initial target is Feline Chronic Gingivostomatitis (FCGS), a painful mouth condition in cats, with FDA approval expected by early 2026.
  • Gallant's approach uses ready-to-use stem cells from donor animals, potentially across species, eliminating the need for patient-specific cell harvesting.
  • Previous studies in dogs with arthritis showed improvements in pain and mobility lasting up to two years, though results for kidney disease in cats were mixed.

FDA Approves Thermo Fisher's Rapid NGS Companion Diagnostic for ZEGFROVY in NSCLC

FDA Approval
  • The FDA has approved Thermo Fisher's Oncomine Dx Express Test on the Ion Torrent Genexus Dx Integrated Sequencer as a companion diagnostic for ZEGFROVY (sunvozertinib) and for tumor profiling.
  • The rapid next-generation sequencing assay delivers genomic insights in as little as 24 hours, bringing precision oncology testing to decentralized clinical settings.
  • ZEGFROVY is the only approved EGFR TKI targeting EGFR exon 20 insertion mutations in non-small cell lung cancer patients.
  • The automated sequencer makes NGS technology accessible to smaller laboratories without previous NGS expertise, potentially improving patient access to targeted therapies.

Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer with EGFR or HER2 Mutation (WU-KONG1)

NCT03974022Active, Not RecruitingPhase 1
Dizal Pharmaceuticals
Posted 7/9/2019

MedPath

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

© 2025 MedPath, Inc. All rights reserved.