Hansa Biopharma Submits BLA to FDA for Imlifidase in desensitization for Kidney Transplantation

Rhea-AI Summary

Hansa Biopharma (NASDAQ: HNSA) submitted a Biologics License Application (BLA) to the FDA on Dec 19, 2025 for imlifidase to enable desensitization of highly sensitized adult patients undergoing deceased-donor kidney transplantation.

The BLA is supported by the pivotal US Phase 3 ConfIdeS trial which met its primary endpoint with significantly improved 12‑month kidney function by mean eGFR (p < 0.0001) and a key secondary endpoint of 12‑month dialysis independence (p = 0.0007). FDA has granted Fast Track and Orphan Drug Designation; Hansa has requested Priority Review, which if granted could allow approval as early as Q3 2026.

Positive

• Phase 3 ConfIdeS met primary endpoint: mean eGFR improvement (p < 0.0001)
• Key secondary endpoint: 12‑month dialysis independence significant (p = 0.0007)
• Regulatory designations: FDA Fast Track and Orphan Drug
• Priority Review requested, potential approval as early as Q3 2026

Negative

• Priority Review is requested but not yet granted, so 6‑month PDUFA timeline is uncertain
• Approval remains conditional on FDA review; not guaranteed despite positive trial

Key Figures

Trial phase: Phase 3 Follow-up duration: 12 months Sensitization level: cPRA ≥99.9% +4 more

7 metrics

Trial phase Phase 3 Pivotal US ConfIdeS trial

Follow-up duration 12 months Kidney function evaluation in ConfIdeS trial

Sensitization level cPRA ≥99.9% Highly sensitized adult kidney transplant patients

Primary endpoint p-value p < 0.0001 eGFR improvement at 12 months vs control

Dialysis independence p-value p = 0.0007 Dialysis independence at 12 months, secondary endpoint

Review cycle length six-month Potential FDA Priority Review cycle

Potential approval timing Q3 2026 If BLA accepted and Priority Review granted

Market Reality Check

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Market Pulse Summary

This announcement details a key regulatory milestone, with a BLA submission for imlifidase supported...

Analysis

This announcement details a key regulatory milestone, with a BLA submission for imlifidase supported by a pivotal Phase 3 trial showing highly significant efficacy (eGFR p < 0.0001, dialysis independence p = 0.0007). Fast Track and Orphan Drug Designation, along with a requested Priority Review and a possible Q3 2026 decision under PDUFA, highlight a structured path forward. Investors may watch for FDA acceptance of the filing, review designation, and any emerging safety or efficacy updates.

Key Terms

biologics license application, immunoglobulin g (igg), orphan drug designation, fast track, +4 more

8 terms

biologics license application regulatory

"announced the submission of a Biologics License Application (BLA) to the U.S."

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

immunoglobulin g (igg) medical

"cleaves all types of immunoglobulin G (IgG) antibodies both intra- and extra-vascularly"

Immunoglobulin G (IgG) is the most abundant antibody the body makes to spot and neutralize germs and to remember past infections; think of it as the immune system’s long-term security cameras and memory cards. For investors, IgG matters because tests that measure IgG, medicines built from or mimicking IgG, and engineered IgG therapies are common products in diagnostics, vaccines and biopharma pipelines, influencing clinical results, regulatory decisions and potential revenues.

orphan drug designation regulatory

"FDA has granted Hansa Biopharma Fast Track and Orphan Drug Designation"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

fast track regulatory

"FDA has granted Hansa Biopharma Fast Track and Orphan Drug Designation"

A fast track designation is a regulatory label that speeds up the review and communication between a drug developer and regulators for treatments addressing serious illnesses or unmet medical needs. For investors, it matters because it can shorten development time and reduce regulatory delays—like getting a VIP lane at the airport—raising the chance of earlier market access and potential revenue, though it does not guarantee approval.

priority review regulatory

"Hansa has requested Priority ReviewLUND, Sweden, Dec. 19, 2025"

Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.

estimated glomerular filtration rate (egfr) medical

"as measured by mean estimated glomerular filtration rate (eGFR) (p < 0.0001)."

Estimated glomerular filtration rate (eGFR) is a test that measures how well your kidneys are filtering waste from your blood. It helps doctors check kidney health and detect problems early, much like how a water filter's effectiveness can be tested by how clean the water becomes.

prescription drug user fee act (pdufa) regulatory

"communicate a target action date under the Prescription Drug User Fee Act (PDUFA)."

The Prescription Drug User Fee Act (PDUFA) is a law that allows drug companies to pay fees to the government to help speed up the review process for new medicines. This funding aims to ensure that important drugs reach patients faster, which can influence a company's ability to bring products to market efficiently. For investors, PDUFA-related decisions can impact drug approval timelines and company performance.

phase 3 medical

"based on the successful outcome of the pivotal US Phase 3 ConfIdeS trial"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

AI-generated analysis. Not financial advice.

• The application is based on the successful outcome of the pivotal US Phase 3 ConfIdeS trial in highly sensitized patients
• Imlifidase is an enzyme that rapidly and efficiently cleaves all types of immunoglobulin G (IgG) antibodies both intra- and extra-vascularly to inhibit IgG-mediated immune response
• FDA has granted Hansa Biopharma Fast Track and Orphan Drug Designation and Hansa has requested Priority Review

LUND, Sweden, Dec. 19, 2025 /PRNewswire/ -- Hansa Biopharma AB, ("Hansa" or "the Company"), (Nasdaq Stockholm: HNSA), today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for imlifidase. The Company is requesting priority review of the BLA for the use of imlifidase in the desensitization of highly sensitized adult patients undergoing deceased donor kidney transplantation.

Renée Aguiar-Lucander, CEO, Hansa Biopharma said: "The submission of our BLA to the FDA marks a pivotal milestone for Hansa Biopharma and for highly sensitized patients living with end-stage renal disease in the US. If approved, imlifidase has the potential to transform the kidney transplant landscape by enabling highly sensitized patients to also have access to a potentially life-changing kidney transplant that would otherwise be out of reach."

The BLA submission for imlifidase is supported by the highly statistically significant outcome of the pivotal US Phase 3 ConfIdeS trial, which evaluated 12-month kidney function in highly sensitized adult kidney transplant patients (cPRA ≥99.9%) with a positive crossmatch against a deceased donor, compared to a control arm. The trial successfully met its primary endpoint, demonstrating significantly improved kidney function in the imlifidase arm at 12 months as measured by mean estimated glomerular filtration rate (eGFR) (p < 0.0001). A key secondary endpoint—dialysis independence at 12 months—was also statistically significant in favor of imlifidase (p = 0.0007). Imlifidase was generally well tolerated, with a safety profile consistent with previous clinical trial experience.

Upon determination of acceptance of the application for review, FDA will communicate a target action date under the Prescription Drug User Fee Act (PDUFA). Hansa has requested priority review for the BLA, which if granted would establish a six-month review cycle with a potential for an approval as early as Q3 2026. 

About ConfIdeS

ConfIdeS is a pivotal Phase 3 open label, randomized, controlled trial of imlifidase in kidney transplantation. The trial evaluated kidney function at 12 months in 64 highly sensitized (cPRA ≥99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with a control arm. A total of 25 US sites participated in the trial, and the primary endpoint was kidney graft function at 12 months, measured by mean eGFR (estimated glomerular filtration rate). The total trial duration is five years, which includes a long-term follow-up agreed with the FDA as part of the accelerated approval pathway. 

About imlifidase

Imlifidase is conditionally approved in the European Union, Norway, Lichtenstein, Iceland and the UK under the tradename IDEFIRIX^® for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. IDEFIRIX^® is also approved in Australia and Switzerland.

Information about the trial is available at ClinicalTrials.gov: NCT04935177

This is information that Hansa Biopharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 20:35 CET on December 19, 2025.

Contacts for more information:

Evan Ballantyne, Chief Financial Officer
IR@hansabiopharma.com

Kerstin Falck Lagercrantz, VP Global Corporate Affairs
media@hansabiopharma.com
kerstin.falck@hansabiopharma.com

Notes to editors

About IDEFIRIX^® (imlifidase)

Imlifidase is an antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets and cleaves immunoglobulin G (IgG) antibodies and inhibits IgG-mediated immune response.¹ It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration.

Imlifidase has conditional marketing approval in Europe and is marketed under the tradename IDEFIRIX for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. The use of IDEFIRIX should be reserved for patients who are unlikely to be transplanted under the available kidney allocation system, including prioritization programs for highly sensitized patients.¹ IDEFIRIX was reviewed as part of the European Medicines Agency's (EMA) PRIority Medicines (PRIME) program, which supports medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options.¹

The efficacy and safety of imlifidase as a pre-transplant treatment to reduce donor-specific IgG was studied in four Phase 2 open-label, single-arm, six-month clinical trials.^2,3-5 Hansa is collecting further clinical evidence and will submit additional efficacy and safety data based on one observational follow-up study and one post-approval efficacy study.

Full EU product information can be accessed via the initial Summary of Product Characteristics found here.

About kidney failure

Kidney disease can progress to kidney failure or End-Stage Renal Disease (ESRD), identified when a patient's kidney function is less than 15%.⁶ ESRD poses a significant health burden, affecting nearly 2.5 million patients worldwide.⁶ A kidney transplant is the treatment of choice for suitable patients with ESRD because it offers improved survival and quality of life benefits, and is cost savings compared to long-term dialysis. There are approximately 170,000 kidney patients in the US and Europe waiting for a new kidney.⁷

About Hansa Biopharma

Hansa Biopharma AB is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative, lifesaving and life-altering treatments for patients with rare immunological conditions. The company has a rich and expanding research and development program based on its proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in autoimmune diseases, gene therapy and transplantation. The company's portfolio includes imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients and HNSA-5487, a next-generation IgG cleaving molecule with redosing potential. Hansa Biopharma is based in Lund, Sweden, and has operations in Europe and the US The company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at www.hansabiopharma.com and follow us on LinkedIn.

©2025 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and IDEFIRIX flower logo are trademarks of Hansa Biopharma AB, Lund, Sweden. All rights reserved.

Forward-Looking Statements

This press release contains forward-looking statements relating to the business of Hansa, including, without limitation, statements regarding Hansa's strategy, commercialization efforts, business plans, regulatory submissions, clinical development plans, revenue and product sales projections or forecasts and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Hansa's business and operations, the presumed mechanism of action of imlifidase, the safety and efficacy of imlifidase in the patient population above or other potential indications, market acceptance of imlifidase, competitive products, anticipated timelines and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. Hansa cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Hansa disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Hansa's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

References

1. European Medicines Agency. Idefirix® summary of product characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/idefirix-epar-product-information_en.pdf.

2. Heidt S, et al. Highly Sensitized Patients are Well Serves by Receiving a Compatible Organ Offer Based on Acceptable Mismatches. Front Immunol. 2021;12:687254. Available at: https://pubmed.ncbi.nlm.nih.gov/34248971/

3. Jordan SC, et al. IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation. N Engl J Med. 2017 Aug 3;377(5):442-453. doi: 10.1056/NEJMoa1612567. Erratum in: N Engl J Med. 2017 Oct 26;377(17):1700. doi: 10.1056/NEJMx170015.

4. Winstedt L, et al. Complete Removal of Extracellular IgG Antibodies in a Randomized Dose-Escalation Phase I Study with the Bacterial Enzyme IdeS--A Novel Therapeutic Opportunity. PLoS One. 2015 Jul 15;10(7):e0132011. doi: 10.1371/journal.pone.0132011. PMID: 26177518; PMCID: PMC4503742.

5. Lorant T, et al. Safety, immunogenicity, pharmacokinetics, and efficacy of degradation of anti-HLA antibodies by IdeS (imlifidase) in chronic kidney disease patients. Am J Transplant. 2018 Nov;18(11):2752-2762. doi: 10.1111/ajt.14733.

6. NIH (2018). What is kidney failure? Available at: https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/what-is-kidney-failure.

7. Newsletter Transplant 2022. International figures on donation and transplantation. Available at: Newsletter Transplant - latest edition I Freepub (edgm.eu) Accessed: May 2025

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2025-12-19 imlifidase BLA submission PR ENG FINAL

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SOURCE Hansa Biopharma AB

FAQ

What did Hansa Biopharma announce about imlifidase and the FDA on Dec 19, 2025 (HNSA)?

Hansa submitted a BLA to the FDA for imlifidase for desensitization in highly sensitized adult deceased‑donor kidney transplant patients and requested Priority Review.

What were the pivotal Phase 3 ConfIdeS trial results cited in Hansa's BLA for imlifidase (HNSA)?

The ConfIdeS trial met its primary endpoint with significantly improved 12‑month mean eGFR (p < 0.0001) and showed higher 12‑month dialysis independence (p = 0.0007).

Has the FDA given any special designations for imlifidase (HNSA)?

Yes. The FDA granted Fast Track and Orphan Drug designation for imlifidase; Hansa has also requested Priority Review.

When could imlifidase potentially be approved if FDA grants Priority Review for HNSA's BLA?

If Priority Review is granted, Hansa says a six‑month review could allow potential approval as early as Q3 2026, subject to FDA action.

What population was enrolled in the ConfIdeS trial supporting Hansa's BLA (HNSA)?

The trial enrolled highly sensitized adult kidney transplant patients with calculated panel‑reactive antibody (cPRA) ≥99.9% and a positive crossmatch against a deceased donor.