HNSA-5487 / Hansa Biopharma - LARVOL DELTA

Hansa Biopharma publishes 2024 Annual and Sustainability Reports (PRNewswire) - "'2024 was a momentum-building year for Hansa. With year-on-year IDEFIRIX sales growth of 83%, a successful financing round'...Preparation for commercialization in the US is progressing, with complete randomization of the pivotal Phase 3 trial - ConfIdeS - announced in May 2024. Data readout for the trial and submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) are planned in 2H 2025...The company plans to align with regulatory authorities in the first half of 2025 on a clinical development path for HNSA-5487 in MG...In Autoimmune, enrolment was completed for the GOOD-IDES-02 Phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease in December, with data readout expected in the second half of 2025."

Commercial • FDA filing • P3 data • Regulatory • Immunology • Myasthenia Gravis • Rare Diseases • Transplantation

Hansa Biopharma half year report 2023 (GlobeNewswire) - "Guillain-Barré Syndrome (GBS)...Results of a comparative efficacy analysis matched to a cohort from the International GBS Outcome Study (IGOS) expected in 2024...HNSA 5487: Enrollment in the phase 1 study in healthy volunteers is completed. Once the Phase 1 data has been analyzed, we will decide on next steps for further clinical development...'Beyond our exciting programs we are very excited to announce the first patient treated with imlifidase in an investigator-initiated phase 2 trial in ANCA-associated vasculitis to assess efficacy and safety of imlifidase together with standard of care in the treatment of patients with pulmonary haemorrhage due to severe ANCA-associated vasculitis...Upcoming milestones and news flow: H2 2023 GBS Phase 2: First data readout."

Enrollment closed • Observational data • P2 data • Trial status • ANCA Vasculitis • Immunology • Vasculitis