Swedish drugmaker Hansa Biopharma is positioning itself for a potential US stock market listing as a critical regulatory verdict on its kidney transplant drug draws near.
The company submitted draft forms to the Securities and Exchange Commission for a possible initial public offering of American Depositary Shares in the US, alongside a proposed private placement in Europe for certain investors.
Hansa clarified in its securities filing that it has yet to decide how many shares to offer, at what price, or when the offering might take place.
Should the plan move forward, Hansa intends to trade on the Nasdaq under the ticker HNSA, while maintaining its existing listing on Nasdaq Stockholm under the same symbol.
The submission represents an early step in a longer process, with the plan remaining subject to review by both Nasdaq and the SEC before any listing can proceed.
The FDA has set a target decision date of December 19 for imlifidase, the company’s antibody-cleaving enzyme designed for desensitization treatment in highly sensitized kidney transplant patients.
Hansa has operated as a commercial-stage company since 2020, when the European Union approved imlifidase for kidney transplant patients who struggle to find organ matches due to high antibody levels that attack foreign tissues.
The drug, marketed under the brand name Idefirix, has also received regulatory clearance in Australia, Norway, Liechtenstein, Iceland, the United Kingdom, and Switzerland.
Positive US phase 3 results reported in late September 2025 showed that patients receiving imlifidase achieved statistically significant improvements in kidney function, as measured by estimated glomerular filtration rate at the one-year mark, helping the trial meet its primary endpoint.
Hansa’s chief operating officer and US chief, Maria Törnsén, stated that “[t]he unmet needs in the US kidney transplant market are significant,” adding that the highly sensitized patients the company targets represent roughly 10% to 15% of the approximately 100,000 people on the US kidney transplant waiting list.
In May, Hansa agreed to sell Idefirix development and commercialization rights across the EU, UK, Switzerland, Norway, Liechtenstein, Iceland, and the Middle East and North Africa region to privately held SERB Pharmaceuticals for 115 million euros.
That deal closed on July 1, with CEO Renée Aguiar-Lucander stating the transaction “strengthens Hansa’s financial position as we continue to prepare for a potential US launch of imlifidase, subject to US approval, and advance our broader R&D pipeline.”
The divestiture of European rights signals a clear strategic pivot toward the US market, where a successful FDA approval could open access to a substantial pool of transplant patients in urgent need of desensitization options.