Imlifidase

With the FDA expected to weigh in on its kidney transplant drug, imlifidase, shortly before year-end, Hansa Biopharma is mulling over its stock listing options in the U.S. Late last week, the Swedish drugmaker said it had submitted draft forms to the Securities and Exchange Commission (SEC) for a possible initial public offering of American Depositary Shares (ADS) in the U.S., plus a proposed private placement in Europe for certain investors. In its securities filing, Hansa clarified that it has yet to decide how many shares to offer, at what price or when. Should the plan progress, Hansa said it aims to trade on the Nasdaq under the HNSA ticker. At the same time, the company says it would maintain the listing of its ordinary shares on Nasdaq Stockholm, where it trades under the same symbol. The paperwork represents a first step by Hansa for a potential U.S. listing. The plan remains subject to Nasdaq and SEC review, the biopharma said with a caveat. Hansa has operated as a commercial-stage drugmaker since 2020, when the European Union cleared the way for imlifidase for desensitization in kidney transplant patients who have difficulty finding an organ match because their bodies produce high levels of antibodies that are meant to attack foreign tissues. The drug has secured green lights in Australia, Norway, Liechtenstein, Iceland, the United Kingdom and Switzerland, as well, where it is marketed under the brand name Idefirix. Now, the company’s commercial fate in the U.S. comes down to an FDA target decision date on imlifidase set for Dec. 19. Hansa reported positive U.S. phase 3 results on the antibody-cleaving enzyme for desensitization treatment in highly sensitive kidney patients late last September, paving the way for its FDA filing. Patients in the study who received Hansa’s drug charted statistically significant improvements in kidney function, as tracked by estimated glomerular filtration rate (eGFR), at the one-year mark, helping the trial meet its primary endpoint. At the time, Hansa’s chief operating officer and U.S. chief, Maria Törnsén, noted on a call that “[t]he unmet needs in the U.S. kidney transplant market are significant.” The highly sensitized patients Hansa is targeting make up about 10% to 15% of the roughly 100,000 people on the U.S. kidney transplant list, she added. In another potential signal toward Hansa’s intended focus on the U.S. market, the company in May agreed to sell Idefirix development and commercialization rights in the EU, U.K., Switzerland, Norway, Liechtenstein, Iceland and the Middle East and North Africa region to privately held SERB Pharmaceuticals, pocketing 115 million euros in the process. The deal closed on July 1, with Hansa’s CEO, Renée Aguiar-Lucander, noting in an announcement that 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.”

Sweden-based Hansa Biopharma AB (Nasdaq Stockholm: HNSA), a commercial-stage immunology company with an EU-approved enzyme therapy and a pending US FDA decision due in December, has submitted a confidential draft Form F-1 registration statement to the SEC for a potential US offering and listing of American Depositary Shares (ADSs) on the Nasdaq Global Market under the ticker HNSA. The company is also considering a concurrent private placement of ordinary shares to qualified investors in Europe. The proposed transaction would effectively give Hansa a secondary US listing while retaining its existing Nasdaq Stockholm listing. The ADS-to-share ratio, offering size, price range, and use of proceeds have not yet been determined, and completion remains subject to market and other conditions. In March 2026, Hansa secured USD 30 million in convertible senior notes from funds managed by Athyrium Capital Management, extending its cash runway into mid-2027. A US listing could broaden the company's access to specialist biotech investors as it approaches a major regulatory catalyst for its lead asset. Hansa's lead product, imlifidase (Idefirix), is a first-in-class IgG-cleaving enzyme conditionally approved in the EU, Australia, and Switzerland for desensitization of highly sensitized kidney transplant patients. The US FDA accepted Hansa's Biologics License Application (BLA) in February 2026 and assigned a December 19, 2026 Prescription Drug User Fee Act (PDUFA) action date. The pivotal Phase III ConfIdeS trial met its primary endpoint with statistical significance (p<0.0001), according to the company. The timing of the proposed US listing therefore comes ahead of a potentially significant expansion of Hansa's commercial footprint. Imlifidase is not currently approved in the US, where highly sensitized kidney transplant candidates are managed using approaches including plasmapheresis and intravenous immunoglobulin rather than an approved IgG-cleaving desensitization therapy. Hansa's pipeline also includes HNSA-5487, a next-generation IgG-cleaving enzyme being developed for Guillain-Barré syndrome. Access the AllSci platform to explore the science behind the news. Spot something wrong? Report an issue with this article