Hansa Biopharma (HNSA) Leerink Global Healthcare Conference 2026 summary

Clinical development and trial results

• Phase 3 data for imlifidase will be presented at the American Transplant Congress in June, with plans to start a new trial before year-end.

• Imlifidase enables rapid and predictable desensitization in highly sensitized kidney transplant patients, reducing IgG by over 95% within 2–6 hours.

• ConfIdeS pivotal trial showed only 3 of 32 control patients could proceed to transplant, versus 27 in the imlifidase arm, highlighting significant unmet need.

• 12-month eGFR was 59.3 mL/min for imlifidase-treated patients versus 23.1 mL/min for controls, indicating strong kidney function outcomes.

• Long-term pooled data show outcomes for imlifidase-treated patients are comparable to non-sensitized transplant recipients.

Regulatory and approval status

• FDA was highly involved in trial design, insisting on a control arm despite lack of standard of care.

• BLA was accepted in February, with a standard review assigned after internal FDA debate.

• FDA communications have been positive, with no AdCom expected for the application.

Commercial strategy and market access

• U.S. launch will target 100 centers responsible for 80% of kidney transplants, with a field team of 15–20 people.

• 25 of these centers participated in the ConfIdeS trial, ensuring strong clinical familiarity.

• Pre-commercial activities focus on stakeholder engagement and market access, leveraging DRG codes and applying for NTAP to secure additional reimbursement.

• European experience highlighted the importance of clinical experience and robust data for adoption; U.S. market is better positioned due to broader trial participation and established reimbursement pathways.