If approved, imlifidase will be the first treatment to address highly sensitized patients awaiting kidney transplantation. Lund, Sweden, 4 March 2026. Hansa Biopharma AB, (“Hansa” or “the Company”), (Nasdaq Stockholm: HNSA), today announced that the Food and Drug Administration (FDA) has notified the company that the previously accepted Biologics License Application (BLA) for imlifidase has been […]
Lund, Sweden, 18 February 2026. Hansa Biopharma AB, (“Hansa” or “the Company”), (Nasdaq Stockholm: HNSA), today announced that its Biologics License Application (BLA) for imlifidase has been accepted by the U.S. Food and Drug Administration (FDA). FDA’s filing review was completed on day 60 which is meant to verify that the submission is substantially complete […]
· Strong Q4 with 76.0 MSEK in revenue, up 135% from Q4 2024. · Submission of Biologics License Application (BLA) for imlifidase for highly sensitized patients awaiting kidney transplantation. · Successfully completed a directed share issue raising 671.5 MSEK (~ $71.3M). Lund, Sweden, 11 February 2026. Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm: HNSA), today announced its […]
Company unveils patented technology designed to help maintain healthy blood flow during vascular procedures Backed by Sofinnova MD Start and led by experienced medtech entrepreneurs and cardiologists PARIS, France – November 4, 2025 – Tulyp Medical, a Paris-based startup developing a medical device for intelligent pressure-driven perfusion, emerged from stealth and announced it has submitted […]
Recognizes the potential of HDP-101 to address a serious or life-threatening condition with high unmet medical needs Enables more frequent engagement with FDA and eligibility for rolling review to support expedited development and review Ladenburg, Germany, 23 October 2025 – Heidelberg Pharma AG (FSE: HPHA), a clinical-stage biotech company developing innovative Antibody Drug Conjugates (ADCs), […]
