Dagens industri: Hansa Biopharma Eyes Multi-Billion Dollar US Market

Following the successful completion of a Phase 3 study for its drug imlifidase, Hansa Biopharma (STO:HNSA) experienced a significant stock surge, as reported by Dagens industri. Shares rose over 20%, increasing the company's market capitalization by approximately 650 million kronor. The study met its primary endpoint, paving the way for a potential U.S. market launch. Imlifidase is designed to facilitate kidney transplants for highly sensitized patients awaiting donor organs. CEO Renée Aguiar-Lucander lauded the "very strong result" and estimated the potential U.S. market opportunity to be "several billion dollars." Hansa Biopharma intends to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) before the end of the year. The company is hopeful that the FDA will grant priority review status, potentially accelerating approval to the third quarter of the following year. Absent priority review, approval is anticipated in the fourth quarter. Aguiar-Lucander believes priority review is highly probable, given the rare disease designation and the absence of currently approved treatments for this patient population. An estimated 10,000 to 15,000 of the 100,000 individuals in the U.S. awaiting kidney transplantation are classified as highly sensitized. This achievement marks a significant milestone for Aguiar-Lucander, formerly the CEO of Calliditas Therapeutics (CALT) prior to its acquisition. Since her appointment as CEO of Hansa Biopharma in April, the company's stock has increased by 85%, reaching its highest level in nearly a year, according to Dagens industri.