Imlifidase, an IgG-destroying enzyme, could receive FDA approval in the second half of 2026 and hit peak sales of $306 million, according to William Blair.
Hansa Biopharma’s investigational enzyme therapy imlifidase demonstrated significant kidney function improvements in a late-stage study of kidney transplant patients, clearing the biotech’s path toward an FDA filing.
These data, presented Wednesday, come from the Phase III ConfideS trial, which enrolled 64 adults who had undergone kidney transplantation. Treatment with imlifidase resulted in “statistically significant and clinically meaningful” kidney function benefits at 12 months, as measured by mean estimated glomerular filtration rate, compared to a control arm.
ConfideS also showed that significantly more patients on imlifidase were no longer dependent on dialysis at 12 months.
“This is a key inflection for Hansa, as it will unlock the large U.S. kidney transplant market opportunity,” according to analysts at William Blair, who in a note to investors on Thursday estimated peak imlifidase sales of $306 million. Hansa plans to file a Biologics License Application for the drug candidate by the end of the year, which William Blair expects could lead to an approval “in the second half of 2026.”
Still, the analysts in their Thursday note pointed to other key secondary outcomes, such as graft and patient survival, which Hansa told investors in a call on Thursday failed to reach significance. This did not seem to deter William Blair, which wrote that “we would not have expected a 12-month survival endpoint to show a statistically significant benefit for imlifidase and believe longer follow-up will be needed to gauge any” significant impact of treatment.
ConfideS also detected episodes of delayed graft function (DGF), according to William Blair, though cases were balanced between the imlifidase and control arms. Antibody-mediated rejections (AMR) did not lead to transplant losses. “Rates of DGF and AMR will be important for assessing the ability of imlifidase to drive longer-term clinical benefit in patients,” the analysts wrote, noting that Hansa is still currently conducting a more thorough analysis of these outcomes.
Shares of Hansa in Stockholm are up about 7.4% in Friday trading.
Designed to be administered intravenously, imlifidase is a protease extracted from IgG-degrading enzymes in Streptococcus pyogenes bacteria. It works by specifically targeting IgG antibodies and cleaving them, in turn suppressing the body’s ability to reject kidney transplants. The therapy was approved in August 2020 in the European Union, where it is marketed under the brand name Idefirix.
