(AGENPARL) - Roma, 30 Ottobre 2025 - (AGENPARL) – Thu 30 October 2025 7.00 AM CET / 30-Oct-2025 / Hansa Biopharma AB (STO:HNSA)
· Imlifidase successfully met primary endpoint in pivotal US Phase 3 ConfIdeS
trial in kidney transplantation.
· First clinical data supports imlifidase ability to substantially reduce anti
-AAV antibodies to allow administration of gene therapy.
Lund, Sweden, 30 October 2025. Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm:
HNSA), today announced its interim report for January-September 2025.
Renée Aguiar-Lucander, CEO, Hansa Biopharma said, “A key milestone in Q3 was the
highly statistically significant outcome of the ConfIdeS trial, where imlifidase
met its primary endpoint of eGFR at 12 months in kidney transplantation. This
marks the first time imlifidase has been evaluated in a randomized and
controlled trial, and we are thrilled with the results. The data clearly
demonstrate a statistically significant (p < 0.0001) and clinically meaningful
benefit for the highly sensitized patients in the imlifidase arm, underscoring
the urgent need for effective desensitization therapies. These findings offer
real hope to patients who currently face years on dialysis and limited
transplant options. Based on the strength of the data, we are targeting a
Biologics License Application (BLA) submission to the FDA under the accelerated
approval pathway before year-end 2025, and we intend to request Priority Review.
Two gene therapy trials, one sponsored by Sarepta and the other sponsored by
Genethon, the latter reported as a subsequent event, support the ability of
imlifidase to substantially reduce anti-AAV antibodies to allow administration
of gene therapy, which is very exciting.”
Financial Performance
Year to date IDEFIRIX product sales totalled 143.6 MSEK and represented an
increase of 29.1 MSEK or 25.4% compared to the same period a year ago (114.5
MSEK). Year to date product sales represent approximately 102% of total full
-year product sales achieved in 2024. Product sales in the third quarter of 2025
totalled 30.1 MSEK, compared to 39.8 MSEK for the same period in 2024.
Lower sales numbers in the third quarter are largely driven by fewer than
expected kidney transplants during the summer period, the pause in the German
Eurotransplant Prioritized Program and reimbursement challenges in Catalunya,
one of the largest regions in Spain. Several corporate initiatives will be
rolled out during Q4 to capture the existing market potential and support
enhanced growth in 2026 and beyond
Pipeline Progress
U.S. ConfIdeS trial: Imlifidase successfully achieved its primary endpoint in
the U.S. Phase 3 pivotal ConfIdeS study in kidney transplantation. At 12 months,
mean eGFR was 51.5 mL/min/1.73m[2] in the imlifidase arm compared to 19.3
mL/min/1.73m[2] in the control arm demonstrating a statistically significant and
clinically meaningful difference of 32.2 mL/min/1.73m[2] (p