Hansa Biopharma's Biologics License Application (BLA) for imlifidase accepted by the FDA

Rhea-AI Summary

Hansa Biopharma (Nasdaq: HNSA) announced the U.S. FDA accepted its Biologics License Application for imlifidase on Feb 18, 2026.

The FDA completed its 60-day filing review; Hansa expects a 74-Day Letter outlining review plans and timelines. The BLA is supported by a positive pivotal U.S. Phase 3 ConfIdeS trial showing significant 12-month eGFR and dialysis-independence benefits.

Imlifidase rapidly inactivates >95% of donor-specific IgG antibodies within 2–6 hours and was generally well tolerated in trials.

Positive

• FDA accepted BLA for imlifidase on Feb 18, 2026
• Phase 3 ConfIdeS met primary endpoint: significant 12-month eGFR improvement (p < 0.0001)
• Key secondary endpoint dialysis independence at 12 months significant (p = 0.0007)
• Imlifidase inactivates >95% donor-specific IgG antibodies within 2–6 hours

Negative

• FDA review outcome and final approval timeline remain uncertain pending 74-Day Letter

Key Figures

Filing review duration: 60 days Antibody inactivation: > 95% Onset window: 2–6 hours +5 more

8 metrics

Filing review duration 60 days FDA filing review completed on day 60

Antibody inactivation > 95% Donor-specific antibodies inactivated within hours of imlifidase

Onset window 2–6 hours Time to inactivate donor-specific antibodies after administration

Follow-up duration 12 months Kidney function evaluated at 12 months in Phase 3 ConfIdeS

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

Primary endpoint p-value p < 0.0001 Improved eGFR at 12 months in imlifidase arm

Secondary endpoint p-value p = 0.0007 Dialysis independence at 12 months favoring imlifidase

Dialysis independence timepoint 12 months Key secondary endpoint timing in ConfIdeS trial

Market Reality Check

normal vol

Market Pulse Summary

This announcement details FDA acceptance of the BLA for imlifidase, supported by pivotal Phase 3 Con...

Analysis

This announcement details FDA acceptance of the BLA for imlifidase, supported by pivotal Phase 3 ConfIdeS data in highly sensitized kidney transplant candidates (cPRA ≥99.9%). The trial achieved a highly significant primary endpoint in kidney function (eGFR, p < 0.0001) and a key secondary endpoint of dialysis independence (p = 0.0007). Investors may track the upcoming 74-Day Letter, overall safety profile, and progression of the regulatory review over the coming months.

Key Terms

biologics license application, u.s. food and drug administration, fda

3 terms

biologics license application regulatory

"announced that its Biologics License Application (BLA) for imlifidase"

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.

u.s. food and drug administration regulatory

"accepted by the U.S. Food and Drug Administration (FDA)."

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

fda regulatory

"accepted by the U.S. Food and Drug Administration (FDA)."

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

AI-generated analysis. Not financial advice.

LUND, Sweden, Feb. 18, 2026 /PRNewswire/ -- Hansa Biopharma AB, ("Hansa" or "the Company"), (Nasdaq Stockholm: HNSA), today announced that its Biologics License Application (BLA) for imlifidase has been accepted by the U.S. Food and Drug Administration (FDA).

FDA's filing review was completed on day 60 which is meant to verify that the submission is substantially complete and meets the requirements for a full evaluation.

Renée Aguiar-Lucander, CEO, Hansa Biopharma said: "We now look forward to receiving the 74-Day Letter which will provide details regarding review plan, timelines and other pertinent information and start working with the FDA as they go through their review over the coming months."

Imlifidase is a unique IgG-cleaving enzyme that rapidly inactivates > 95% of donor-specific antibodies within 2–6 hours of administration, providing a crucial window to enable HLA-incompatible kidney transplantation.

The BLA submission for imlifidase is supported by the previously communicated highly statistically significant outcome of the pivotal U.S. 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. 

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 U.S. 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 19:53 CET on February 18, 2026.

--- ENDS ---

Contacts for more information:

Evan Ballantyne, Chief Financial Officer
IR@hansabiopharma.com

Kerstin Falck, 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 developing and commercializing novel immunomodulatory therapies to transform care for patients with acute or complex immune disorders. Hansa's proprietary IgG-cleaving enzyme technology platform to address serious unmet medical needs in transplantation, gene therapy and autoimmune diseases. 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 that will be developed for Guillain-Barré Syndrome (GBS). Hansa Biopharma is based in Lund, Sweden, and has operations in Europe and the U.S. The company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at  www.hansabiopharma.com  and follow us on LinkedIn.

©2026 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

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/hansa-biopharma-ab/r/hansa-biopharma-s-biologics-license-application--bla--for-imlifidase-accepted-by-the-fda,c4309758

The following files are available for download:

https://mb.cision.com/Main/1219/4309758/3941886.pdf

2026-02-18 BLA FDA imlifidase PR ENG FINAL

View original content:https://www.prnewswire.com/news-releases/hansa-biopharmas-biologics-license-application-bla-for-imlifidase-accepted-by-the-fda-302691919.html

SOURCE Hansa Biopharma AB

FAQ

What does FDA acceptance of Hansa Biopharma's BLA for imlifidase (HNSA) mean?

It means the FDA will perform a full review of the BLA submission for imlifidase. According to the company, the FDA completed the 60-day filing review and will issue a 74-Day Letter detailing review plans, timelines, and next steps.

What clinical evidence supports Hansa's BLA for imlifidase (HNSA) submitted Feb 18, 2026?

The BLA is backed by the pivotal U.S. Phase 3 ConfIdeS trial showing significant benefits at 12 months. According to the company, ConfIdeS met its primary eGFR endpoint (p < 0.0001) and a key secondary, dialysis independence (p = 0.0007).

How quickly does imlifidase inactivate donor-specific antibodies as reported by Hansa (HNSA)?

Imlifidase rapidly inactivates more than 95% of donor-specific IgG antibodies within hours. According to the company, antibody inactivation occurs within 2–6 hours after administration, creating a window for HLA-incompatible kidney transplantation.

What safety outcomes did Hansa report for imlifidase in the Phase 3 ConfIdeS trial?

Imlifidase was generally well tolerated with a safety profile consistent with prior trials. According to the company, no new safety signals were reported and overall tolerability matched earlier clinical experience.

When will investors learn the FDA's review timeline for imlifidase (HNSA)?

Investors will receive detailed timing in the FDA's 74-Day Letter following acceptance. According to the company, the 74-Day Letter will outline the review plan and expected timelines over the coming months.

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

ConfIdeS enrolled highly sensitized adult kidney transplant patients with cPRA ≥99.9% and positive crossmatch to a deceased donor. According to the company, results reflect this specific high-immunologic-risk population.