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Investing.com -- Jefferies in a note dated Wednesday has initiated coverage on Hansa Biopharma AB with a “buy” rating and a price target of SEK 100, citing momentum from its first-in-class IgG-cleaving enzyme Idefirix and the company’s planned expansion into the U.S. market.
Shares of the Sweden-based biotechnology company were up 5.9% at 08:22 ET (12:22 GMT).
The analysts said that “HNSA’s value is anchored by first‑in‑class IgG‑cleaving enzyme Idefirix for kidney‑transplant desensitization, already commercial in EU w/ expanding real‑world validation, and newly de‑risked in the U.S. w/ +(ve) pivotal readout.”
Idefirix, also known as imlifidase, is conditionally approved in the European Union for highly sensitized kidney transplant patients and reimbursed in 20 countries, covering about 75% of the EU transplant volume.
Jefferies noted that 114 clinics are ready to treat and 66% show repeat use, although it cautioned that “Germany’s pause of highly sensitized prioritization program can limit near-term use.”
The U.S. pathway has been strengthened by the pivotal Phase 3 ConfIdeS trial, which met its primary endpoint. At 12 months, patients treated with Idefirix had a mean eGFR of 51.5 mL/min compared with 19.3 mL/min in the control group (p < 0.0001) and showed significantly less dialysis dependence (p = 0.0007).
The brokerage said the results “de-risk” the U.S. program ahead of a Biologics License Application (BLA) filing targeted by year-end 2025, with priority review expected.
The analysts expect U.S. approval in 2H26, NTAP inclusion for FY27, and the EU PAES readout in mid-2026 to serve as major regulatory and reimbursement milestones.
The conditional European approval, granted in August 2020, will require PAES confirmation for full approval. Jefferies stated that success could expand Idefirix use beyond highly sensitized deceased donor cases to broader transplant populations.
The company’s near-term upside is driven by regulatory catalysts and a growing commercial base in Europe.
Idefirix has moved from early-access driven sales to “broader, guideline supported launch” with product sales expected to “significantly exceed 2024” as more centers adopt the therapy.
Financially, Hansa reported a pro forma cash position of SEK 854 million (SEK 8 per share) and secured SEK 671 million through a directed share issue in October 2025.
The analysts estimate peak U.S. and EU sales of ~$600 million by 2034, compared with a consensus $350 million, noting that “Idefirix addresses a critical unmet need for highly sensitized kidney transplant pts who can’t receive organs due to pre-formed Abs.”
Jefferies also flagged risks related to policy shifts and supply chain dependency on EU contract manufacturers but emphasized that the U.S. data and cash position anchor confidence ahead of launch.
“U.S. mkt is de-risked by pivotal ConfIdeS success,” the analysts said, calling Idefirix “a game changer” for patients who “can’t receive organs due to pre-formed Abs.”