Hansa Biopharma Pursues Nasdaq Listing Ahead of FDA Decision

Hansa Biopharma is pursuing a Nasdaq listing ahead of the U.S. Food and Drug Administration’s decision on its kidney transplant treatment.

According to Fierce Pharma on the 25th local time, Swedish pharmaceutical company Hansa Biopharma said it submitted draft documents to the U.S. Securities and Exchange Commission last week for an initial public offering of American depositary shares.

The company also presented plans for a private placement targeting certain European investors. However, it explained in the registration statement that the number of shares to be issued, the price and the timing had not yet been determined.

If the plan proceeds, Hansa Biopharma is expected to trade on Nasdaq under the ticker ‘HNSA.’ The company said its ordinary shares, currently listed on Nasdaq Stockholm, will remain listed under the same symbol.

The filing is the first step toward a U.S. listing. However, the company added that the final listing remains subject to review by Nasdaq and the SEC.

Hansa Biopharma entered the commercialization stage in 2020, when the European Union approved imlifidase as a desensitization treatment for kidney transplant patients. The drug has also been approved in Australia, Norway, the United Kingdom and Switzerland, where it is marketed under the brand name Idefirix.

Its commercial success in the United States depends on the FDA’s Prescription Drug User Fee Act goal date for imlifidase, scheduled for Dec. 19.

Hansa Biopharma secured positive results in a U.S. phase 3 trial of highly sensitized kidney transplant patients at the end of September last year. Kidney function, assessed by estimated glomerular filtration rate 1 year after dosing, improved with statistical significance, meeting the primary endpoint.

At the time, Maria Törnsten, chief operating officer and head of the U.S. business, said, “The unmet need in the U.S. kidney transplant market is substantial.” The highly sensitized patients she referred to account for 10% to 15% of approximately 100,000 people on the U.S. kidney transplant waiting list.

Meanwhile, signaling its commitment to the U.S. market, Hansa Biopharma agreed in May to sell Servier Pharmaceuticals the development and commercialization rights for Idefirix in the EU, the United Kingdom, Switzerland and the Middle East and North Africa. The transaction is valued at €115 million (approximately 161 billion won).

The transaction closed July 1. “This agreement strengthens our financial foundation as we prepare for the U.S. launch of imlifidase, subject to U.S. approval, and expand our research and development pipeline,” said René Aguiar-Lucander, chief executive officer.