EMA Grants PRIME Designation to TolerogenixX’s MIC-Lx Therapy for Donor-Specific Immune Tolerance in Kidney Transplantation
— MIC-Lx therapy receives EMA PRIME designation for its potential to reduce or eliminate life-long immunosuppressive therapy
— Long‑term clinical data with up to 10-year follow‑up support sustained safety and reduced immunosuppression
TolerogenixX, a clinical-stage biopharmaceutical company developing personalized cell therapies to induce sustained immune tolerance in organ transplantation and autoimmune diseases, today announced that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation to its lead cell therapy candidate MIC-Lx for individualized immuno-suppression in living donor kidney transplantation. The PRIME scheme supports medicines addressing serious diseases with significant unmet medical need and provides early and enhanced regulatory interaction with the EMA to accelerate clinical development and patient access.
New data demonstrate medical and health‑economic benefits of digital sleep apnea screening
— Analysis shows significant patient benefit and substantial cost‑saving potential through early digital screening for obstructive sleep apnea (OSA)
— Digital, smartphone‑based solutions enable systematic, low‑threshold screening
— More than 20 percent of the adult population in Germany are affected by obstructive sleep apnea requiring treatment
Obstructive sleep apnea (OSA) is a widespread, chronic condition that often remains undiagnosed for long periods and can lead to serious comorbidities such as hypertension or diabetes. Sleep apnea episodes are breathing pauses of up to one minute, during which the body receives less oxygen. These pauses can occur several hundred times per night and may have substantial health consequences. The risk of stroke is doubled and the risk of heart attack is fourfold increased. This can lead to severe health outcomes and significant costs for healthcare systems. Studies indicate that more than 20% of the adult population in Germany suffer from obstructive sleep apnea requiring treatment.
News from akampion
We are pleased to announce that akampion has further strengthened its senior team with the addition of two highly experienced consultants — Francina Agosti, PhD, a trained neuroscientist, and Almut Gebhard, MSc, a trained biologist.
This move further expands akampion’s core strength: senior-level strategic communications advisory in situations where communications become truly value-critical — including financings, key data readouts, strategic milestones, leadership transitions, and early company-building phases.
