#HNSA

StockTitan

@stocktitan.net

1 month ago

Hansa Biopharma has won the 2025 SwedenBIO Award Hansa Biopharma (NASDAQ: HNSA) won the 2025 SwedenBIO Award, presented at the SwedenBIO Summit in Stockholm on 21 January 2026. The award recognized Hansa for converting Swedish scientific excellence into global medical impact, building commercial capabilities for global markets, and advancing enzyme technology that enables transplantation for highly sensitized patients.The company noted strong clinical progress, referencing U.S. Phase 3 data, an upcoming FDA review process, and an anticipated European Phase 3 readout later in 2026. CEO Renée Aguiar-Lucander said the award reflects momentum heading into 2026 and honored the Hansa team.

#HNSA Hansa Biopharma has won the 2025 SwedenBIO Award

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StockTitan

@stocktitan.net

2 months ago

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

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

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StockTitan

@stocktitan.net

4 months ago

Hansa Biopharma Reports Third Quarter and Interim Year to Date 2025 Financial Results Imlifidase successfully met primary endpoint in pivotal US Phase 3 ConfIdeS trial in kidney transplantation. First clinical data supports imlifidase ability to substantially reduce anti-AAV antibodies to allow administration of gene therapy.. LUND, Sweden, Oct. 30, 2025/ PRNewswire/-- Hansa Biopharma AB, "Hansa", today announced its interim report for...

#HNSA Hansa Biopharma Reports Third Quarter and Interim Year to Date 2025 Financial Results

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StockTitan

@stocktitan.net

4 months ago

Hansa hosts call with distinguished transplant surgeons: Insights on clinical practice and imlifidase Phase 3 Results Hansa (Nasdaq: HNSA) will host a virtual event on Wednesday 12 November 2025 at 9:00 AM EST / 15:00 CET featuring transplant surgeons Professor Robert Montgomery and Professor Matthew Cooper.The session includes an introduction by CEO Renée Aguiar-Lucander, presentation of topline results from the US Phase 3 ConfIdeS trial by CMO Richard Philipson, a moderated discussion on clinical practice and the medical need for highly sensitized kidney transplant patients, and a live Q&A.The event aims to provide clinician perspectives on the clinical relevance of the ConfIdeS topline results and potential implications for standard of care in the US transplant community.

#HNSA Hansa hosts call with distinguished transplant surgeons: Insights on clinical practice and imlifidase Phase 3 Results

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Alia Parker

@aliaparker.bsky.social

4 months ago

Announcing the ARA Historical Novel Prize Winners — HNSA - Historical Novel Society Australasia The Historical Novel Society Australasia (HNSA), in conjunction with its generous sponsor ARA Group, is delighted to announce the winners of the richest individual literary prize in Australasia with p...

It’s a tie! This year’s $100,000 Historical Novel Prize has been split down the middle by Robbie Arnott’s Dusk and Tasma Walton’s I am Nannertgarrook. 👏
hnsa.org.au/news-updates...
#hnsa #prize #booksky #authors #writers #australia

Semper Gumby

@dbfenthusiast.bsky.social

5 months ago

Missing #HNSA this year in Buffalo but such is the price of settling into a new job.

StockTitan

@stocktitan.net

5 months ago

Imlifidase successfully meets primary endpoint in pivotal US Phase 3 ConfIdeS trial in kidney transplantation At 12 months, mean eGFR was 51.5 mL/min/1. 73 m 2 in the imlifidase arm versus 19.3 mL/min/1. 73 m 2 in the control arm with a statistically significant and clinically meaningful difference of 32.2 mL/min/1. 73 m 2 (p Imlifidase was generally well tolerated with a safety profile consistent with previous clinical trial experience Submission of a Biologic License...

#HNSBF #HNSA Imlifidase successfully meets primary endpoint in pivotal US Phase 3 ConfIdeS trial in kidney transplantation

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StockTitan

@stocktitan.net

7 months ago

Hansa Biopharma announces key executive appointments to support continued growth Hansa Biopharma (Nasdaq Stockholm: HNSA) has announced three key executive appointments to strengthen its leadership team ahead of potential US market expansion. Brian Gorman joins as Chief Legal Officer and Corporate Secretary, bringing over 20 years of global experience, including significant M&A expertise from roles at Sinclair Pharma, Calliditas Therapeutics, and Opiant Pharmaceuticals.Sandra Frithiof has been appointed as Chief Human Resources Officer, leveraging 25 years of HR experience, notably in supporting US market entry at Calliditas Therapeutics. Additionally, Kerstin Falck Lagercrantz will join as VP Corporate Affairs, bringing extensive experience from Pfizer AB in corporate affairs and commercial operations.These appointments come at a crucial time as Hansa prepares for two Phase 3 readouts and its first BLA submission while strengthening its US pre-commercial activities.

#HNSA Hansa Biopharma announces key executive appointments to support continued growth

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StockTitan

@stocktitan.net

7 months ago

Hansa Biopharma Reports Second Quarter and Interim January-June 2025 Financial Results Hansa Biopharma (NASDAQ:HNSA) reported Q2 2025 financial results, highlighting a 76% year-over-year increase in IDEFIRIX product sales to 47.8 MSEK. The company secured a directed cash share issue of 232 MSEK (US $24.3M) and restructured its NovaQuest debt, with US $14.9M of outstanding debt converted to equity.First half 2025 IDEFIRIX sales reached 113.5 MSEK, representing a 52% increase over 1H 2024. The company's pipeline progress includes upcoming data readouts from two Phase 3 programs in kidney transplantation and anti-GBM, with a planned BLA submission to FDA in second half 2025. The secured financing extends cash runway into Q2 2026.

#HNSA Hansa Biopharma Reports Second Quarter and Interim January-June 2025 Financial Results

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StockTitan

@stocktitan.net

8 months ago

Hansa Biopharma presents positive outcomes of five-year follow-up study of imlifidase in kidney transplantation at ESOT Congress 2025 in London Hansa Biopharma (Nasdaq Stockholm: HNSA) presented positive five-year follow-up data from the 17-HMedIdeS-14 study of imlifidase in kidney transplantation at the 2025 ESOT Congress in London. The extended pooled analysis demonstrated sustained positive outcomes in highly sensitized patients who received imlifidase-enabled kidney transplants.Key findings include a 90% patient survival rate at five years (with three deaths occurring between six months and one year) and a death-censored graft survival rate of 82%. The mean estimated glomerular filtration rate (eGFR) at five years was 50 mL/min/m2, indicating favorable kidney function compared to typical post-transplant outcomes where eGFR usually ranges between 40-60 ml/min per 1.73 m2 at three years with continued decline at five years.The presentation by Dr. Massimo Mangiola from NYU Langone Transplant Institute builds on previously published data in the American Journal of Transplantation, confirming imlifidase as a viable option for HLA-incompatible transplantation with long-term benefits comparable to standard kidney transplants.

#HNSA Hansa Biopharma presents positive outcomes of five-year follow-up study of imlifidase in kidney transplantation at ESOT Congress 2025 in London

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Joey

@suspendedjoey.bsky.social

9 months ago

Sarepta, nytt dödsfall och delar av patientpopulation stoppas från dosering. Hansas studie med Sarepta on clinical hold #srpt #hnsa

Gustav Skanby

@gustavskanby.bsky.social

9 months ago

Tbx i #hnsa?

StockTitan

@stocktitan.net

10 months ago

Breakthrough Phase 2 Results: New Drug Shows Promise in Treating Severe Guillain-Barré Syndrome New clinical data reveals imlifidase's potential as first-in-class treatment for Guillain-Barré Syndrome. Multi-center study demonstrates safety and efficacy. See detailed results.

#HNSA Hansa Biopharma data at the 2025 PNS Annual Meeting demonstrates potential of imlifidase in the treatment of GBS

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StockTitan

@stocktitan.net

10 months ago

Hansa Biopharma Reports First Quarter and Interim January-March 2025 Financial Results Hansa Biopharma (HNSA) reported strong Q1 2025 financial results with total revenue of 66.3 MSEK, driven by IDEFIRIX® product sales of 65.7 MSEK, representing a 39% increase from Q1 2024. Key operational highlights include:- Completed enrollment in Post Authorization Efficacy and Safety study- Secured access in three additional European markets- Growing repeat utilization of IDEFIRIX® across Europe- Appointment of Renée Aguiar-Lucander as new CEOFinancial metrics:- SG&A expenses: 76.0 MSEK- R&D expenses: 64.3 MSEK- Operating loss: 93.4 MSEK- Net loss: 37.1 MSEK- Cash position: 250.2 MSEKMultiple pipeline catalysts expected in H2 2025, including data readouts from U.S. ConfIdeS Phase 3 trial in kidney transplantation and anti-GBM Phase 3 trial.

#HNSA Hansa Biopharma Reports First Quarter and Interim January-March 2025 Financial Results

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StockTitan

@stocktitan.net

1 year ago

Major Milestone: Hansa's Kidney Transplant Drug Advances with 114-Patient Phase 3 Study Hansa Biopharma achieves key milestone in European Phase 3 study of IDEFIRIX, enrolling 114 patients across 22 sites. Critical data for full EU approval expected in 2026.

#HNSA Hansa Biopharma completes enrolment in European Phase 3 20-HMedIdeS-19 Post Authorization Efficacy and Safety study in highly sensitized kidney transplant patients

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StockTitan

@stocktitan.net

1 year ago

Hansa Biopharma Reports Fourth Quarter and Full Year 2024 Financial Results Hansa Biopharma reported strong financial results for Q4 and full year 2024, with IDEFIRIX product sales showing an 83% increase to 189.7 MSEK compared to the previous year (103.7 MSEK), excluding a 49.6 MSEK provision for retroactive price adjustments. Including the provision, 2024 IDEFIRIX sales reached 140.1 MSEK, a 35% increase year-over-year.The company achieved significant pipeline milestones, including positive Phase 2 results in Guillain-Barré Syndrome, favorable 12-month analysis from the NICE-01 study of HNSA-5487, and completion of enrollment in the GOOD-IDES-02 Phase 3 study. Total revenue for 2024 was 220.9 MSEK (171.3 MSEK after provision), representing a 28% increase from 2023.Q4 2024 showed IDEFIRIX product sales of 25.6 MSEK, with quarterly fluctuations due to European kidney allocation systems. The company's operating loss improved to -637.4 MSEK for 2024 compared to -788.5 MSEK in 2023.

#HNSA Hansa Biopharma Reports Fourth Quarter and Full Year 2024 Financial Results

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StockTitan

@stocktitan.net

1 year ago

Hansa Biopharma's GBS Treatment Shows Breakthrough Results: Patients Walk 6 Weeks Sooner in Phase 2 Trial Hansa's imlifidase demonstrates remarkable efficacy in Guillain-Barré Syndrome, enabling patients to walk independently 6 weeks faster than standard therapy, with 67% walking by week 8.

#HNSA Hansa Biopharma announces positive full results from 15-HMedIdeS-09 Phase 2 study and comparative analysis of imlifidase in patients with Guillain-Barré Syndrome

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StockTitan

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1 year ago

Hansa Biopharma Accelerates Phase 3 Trial for Rare Kidney Disease Treatment, Completes Enrollment Ahead of Schedule | HNSA Stock News Hansa Biopharma reaches milestone in pivotal Phase 3 trial for anti-GBM disease treatment, enrolling 50 patients across global centers. Results expected in 2025.

#HNSA Hansa Biopharma Completes Enrolment in Global Pivotal Phase 3 Trial of imlifidase in Anti-Glomerular Basement Membrane Disease

#StockMarket #stocks #news

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