Hansa Biopharma AB Reports Positive Phase‑3 Results for Imlifidase in Kidney Transplantation

Hansa Biopharma AB (stock ticker: HANSAB on the Swedish Stock Exchange) announced on Thursday that its lead product, the immunomodulatory enzyme imlifidase, achieved its primary endpoint in the pivotal Confides Phase‑3 trial. The study evaluated the drug in highly sensitised patients awaiting kidney transplantation, a population for whom conventional desensitisation strategies are often inadequate.

Trial Highlights

  • Population: High‑sensitised kidney transplant candidates (positive PRA > 80 %).
  • Design: Randomised, controlled, double‑blind, multicentre U.S. study.
  • Primary Endpoint: Successful desensitisation, defined as a reduction of anti‑HLA antibodies below the threshold required for transplantation, with no graft loss at 6 months.
  • Result: 82 % of patients treated with imlifidase met the primary endpoint compared with 16 % in the placebo group (p < 0.001).

The study also demonstrated a favourable safety profile, with the most common adverse events being mild infusion‑related reactions, consistent with the drug’s mechanism of action.

Market Reaction

Following the announcement, Hansa Biopharma’s shares surged 24.3 % in early trading on the Swedish Stock Exchange, pushing the closing price to 33.12 SEK on 23 September 2025. The move reflects investor optimism about the potential for U.S. market entry and the drug’s commercial prospects.

Strategic Implications

CEO Renée Aguiar‑Lucander stated that the positive data “position Hansa Biopharma to tap into the lucrative U.S. market.” The company has been targeting the United States for regulatory approval and commercial launch, where the prevalence of sensitised transplant patients and the high reimbursement rates for specialised therapies create a substantial opportunity.

The success in Confides also strengthens Hansa Biopharma’s pipeline, which focuses on immunomodulatory enzymes for rare diseases and transplant rejection management. With a market cap of 2.68 billion SEK and a current price‑to‑earnings ratio of –3.77, the company remains valued primarily on its developmental achievements rather than on existing revenues.

Outlook

  • Regulatory: The company is expected to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the coming months.
  • Commercial: If approved, imlifidase could become the first approved enzyme therapy for desensitisation in kidney transplantation, potentially generating multi‑million‑dollar revenues.
  • Financial: The share price volatility reflects the high‑growth, high‑risk nature of a biotech with a single product candidate.

Investors and analysts will be watching closely for FDA feedback, pricing negotiations with payers, and the company’s ability to scale manufacturing for a U.S. launch.

This article synthesises publicly available information as of 25 September 2025 and does not constitute investment advice.