Ongoing Phase 2 VacSYn study to expand to sites in USA with Investigational New Drug (IND) clearance Recent positive interim results showed safety and immunogenicity with early signals of activity Full week-100 results from Part 1 of VacSYn trial expected in H2 2026 Lausanne, Switzerland, August 11, 2026 – AC Immune SA (NASDAQ: ACIU), […]
FDA feedback supports Poolbeg’s proposed development pathway for POLB 001, providing further clarity for ongoing partnering discussions 26 May 2026- Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’), a clinical-stage biopharmaceutical company with a core focus on transforming the cancer immunotherapy field, announces the positive outcome of a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug […]
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 […]
