Tag Archive for: liver disease

Data from GNT-018-IDES trial supports feasibility of imlifidase as pretreatment in gene therapy treatment for patients with Crigler–Najjar syndrome who are immune to AAV

Results presented today at ESGCT 2025 PARIS, France, LUND, Sweden (October 10, 2025) – Genethon, a worldwide pioneer and leader in research and development of gene therapy for rare genetic diseases, and Hansa Biopharma, a Sweden-based leader in IgG cleaving enzyme technology announced today that a patient with a rare liver disease and immunity to the AAV […]

Resolution Therapeutics announces first patient dosed in Phase I/II EMERALD study of RTX001 for the treatment of end-stage liver disease

RTX001 is the first engineered Regenerative Macrophage Therapy (RMT) to be evaluated in humans with advanced liver fibrosis First patient has successfully cleared safety period with no serious adverse events Enrolment is now open for the study, with initial data readout expected in 2026 Edinburgh and London, UK, 3 September 2025 – Resolution Therapeutics (“Resolution” or “Company”), a […]

Sequana Medical Announces US FDA Approval of alfapump® for the Treatment of Recurrent or Refractory Ascites due to Liver Cirrhosis

alfapump® is the first US approved active implantable medical device (Class III) for the treatment of recurrent or refractory ascites due to liver cirrhosis PMA Approval and FDA Breakthrough Device Designation US market opportunity estimated at over $2 billion in 2025, growing at 9%[1] due to MASH/NASH[2] and alcoholic liver disease US commercial launch planned for H2 2025 […]

Resolution Therapeutics Receives MHRA Approval to Commence Phase I/II EMERALD Study for Lead Candidate RTX001

EMERALD Study will investigate safety and efficacy of engineered macrophage cell therapy in patients with decompensated liver cirrhosis Edinburgh and London, UK, 27 June 2024 – Resolution Therapeutics Limited (“Resolution”), a clinical-stage biopharmaceutical company developing macrophage cell therapies to treat end-stage liver disease today announces it has received approval from the U.K. Medicines and Healthcare […]

Sequana Medical announces submission of Investigational New Drug (IND) application for DSR® 2.0 for treatment of congestive heart failure

Ghent, Belgium – 03 April 2023 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces that it has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) on 31 March 2023 for its second-generation […]