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Hansa Biopharma, listed on Nasdaq Stockholm under the ticker HNSA, is a pioneering commercial-stage biopharmaceutical company based in Lund, Sweden. The company specializes in developing and commercializing innovative enzyme-based treatments for rare immunological conditions. Hansa has established itself as a leader in the industry with its proprietary immunoglobulin G (IgG) antibody-cleaving enzyme technology, which aims to address significant unmet medical needs in transplantation, autoimmune diseases, gene therapy, and cancer.
Hansa's flagship product, Imlifidase (marketed under the trade name Idefirix®), is an antibody-cleaving enzyme that specifically targets IgG antibodies, enabling kidney transplantation in highly sensitized patients with a positive crossmatch against an available deceased donor. Imlifidase has received conditional marketing approval in Europe and is currently being evaluated in several ongoing trials to expand its indications, including in autoimmune diseases and as a pre-treatment to gene therapy.
Recent notable achievements include the successful recruitment and randomization of patients in the pivotal Phase 3 ConfIdeS trial, which aims to support a Biologic License Application (BLA) submission to the US FDA. This trial seeks to validate imlifidase's role in desensitizing highly sensitized kidney transplant patients in the United States.
The company also announced key executive appointments, such as Dr. Hitto Kaufmann as Chief Scientific Officer and Evan Ballantyne as Chief Financial Officer, to bolster its leadership team. These appointments are part of Hansa's broader strategy to enhance its research, development, and commercial capabilities.
Hansa's research and development pipeline is robust, with multiple clinical trials underway, including studies investigating the efficacy of imlifidase in treating Guillain-Barré Syndrome (GBS) and antibody-mediated rejection (AMR) episodes following kidney transplantation. Preliminary data from these trials have shown promising results, demonstrating imlifidase's potential to improve patient outcomes significantly.
Financially, Hansa is focused on optimizing investments and aligning its resources with key growth opportunities. The company recently announced a planned restructuring to reduce its workforce by 20-25%, expected to result in annual savings of approximately 75-85 million SEK. This move aims to position Hansa for long-term success while continuing to deliver on its mission of developing life-altering treatments for patients with rare diseases.
Hansa Biopharma remains committed to advancing its innovative treatments and expanding its global reach. The company's dedication to scientific excellence and patient-centric approach underscores its potential to make a substantial impact in the biopharmaceutical landscape.
Hansa Biopharma announced positive full results from its Phase 2 study of imlifidase in Guillain-Barré Syndrome (GBS). The study showed that severe GBS patients treated with imlifidase plus IVIg achieved faster recovery, with a median time of 16 days to walk independently. The treatment demonstrated significant advantages compared to standard IVIg therapy alone, with patients walking independently 6 weeks sooner than the control group.
Key findings include: 37% of patients could walk independently within the first week, 67% by eight weeks, and 63% could run or had no functional disability after six months. The comparative analysis showed patients were 6.4 times more likely to walk independently at week 1 and 4.2 times more likely at week 4 compared to the control group.
Hansa Biopharma has completed patient enrollment in the GOOD-IDES-02 trial, a global pivotal Phase 3 trial testing imlifidase for anti-glomerular basement membrane (anti-GBM) disease. The trial enrolled 50 patients across 40+ centers in the US, UK, and EU, ahead of the original 2025 schedule. The study randomized 25 patients to receive imlifidase plus standard of care (SoC) and 25 to receive SoC alone.
The trial aims to evaluate kidney function improvement through estimated glomerular filtration rate (eGFR) and dialysis needs at 6 months. Anti-GBM is a rare autoimmune condition affecting 1.6 people per million annually, with most patients losing kidney function. Imlifidase has received orphan drug designation from both FDA and EMA. Results are expected in 2025.
Hansa Biopharma and Genethon have initiated GNT-018-IDES, a Phase 2 trial evaluating imlifidase as pre-treatment to gene therapy GNT-0003 in patients with Crigler-Najjar syndrome who have pre-existing antibodies against AAV vectors. The trial aims to enable gene therapy treatment for patients previously excluded due to anti-AAV antibodies, which affect up to 1 in 3 potential recipients. The study will include three patients aged ≥18 years requiring phototherapy, with data expected in 2025. GNT-0003 is currently in a pivotal trial and has received EMA PRIME status, potentially becoming the first gene therapy for Crigler-Najjar syndrome.
Hansa Biopharma (HNSA) and Genethon announced the initiation of GNT-018-IDES, a Phase 2 trial combining imlifidase with gene therapy GNT-0003 for Crigler-Najjar syndrome patients with pre-existing anti-AAV antibodies. The trial will evaluate a single intravenous administration of GNT-0003 following imlifidase pre-treatment in three adult patients requiring phototherapy. This collaboration aims to address a significant challenge, as anti-AAV antibodies prevent up to 1 in 3 people from accessing gene therapies. Data from the trial is expected in 2025. GNT-0003 is currently in a pivotal trial and has received EMA PRIME priority status.
Hansa Biopharma (Nasdaq Stockholm: HNSA) announced its participation in the Truist Securities BioPharma Symposium on November 7 in New York. Chief R&D Officer Hitto Kaufmann will join a panel discussion on 'Inflammatory Insights: Advancing Novel Therapeutics Across Autoimmune and Inflammatory Indications' from 10:30 to 11:20 AM EST.
The company recently completed a 12-month follow-up analysis of the NICE-01 trial for HNSA-5487, their next-generation molecule. Results show the drug effectively reduces IgG levels rapidly, offers redosing potential, and maintains a favorable safety profile. Hansa, a pioneer in immunological treatments, has developed a first-in-class IgG antibody-cleaving enzyme therapy for kidney transplantation in highly sensitized patients.
Hansa Biopharma announced positive results from a 12-month follow-up analysis of the NICE-01 trial for HNSA-5487, their next-generation IgG-cleaving molecule. Key findings include:
1. Rapid and robust IgG reduction by over 95% within hours of treatment
2. IgG levels returned to normal range after 6 months
3. Lower pre-treatment anti-drug antibody (ADA) levels and reduced ADA responses compared to imlifidase
4. Clear redosing potential and favorable safety profile
The company plans to focus HNSA-5487's clinical development on chronic autoimmune diseases such as MOGAD, NMO, and MG. These conditions have high unmet medical needs and are caused by misguided IgG antibodies. HNSA-5487's ability to quickly reduce IgG levels could potentially address various symptoms associated with these diseases.
Hansa Biopharma AB (Nasdaq Stockholm: HNSA) has announced the departure of Matthew Shaulis, Chief Commercial Officer and US President, effective late September 2024. The Commercial Leadership team will now report directly to Søren Tulstrup, President and CEO, while a search for a new CCO and US President is underway.
Shaulis expressed pride in the company's progress and its commitment to developing transformative products for patients with rare immunological diseases. Tulstrup acknowledged Shaulis's significant contributions, including commercialization efforts in Europe, acceleration of the ConfIdeS US pivotal study, and initiation of US launch planning.
Hansa Biopharma (NASDAQ Stockholm: HNSA) announced it will publish its interim report for January-June 2024 on July 18, 2024. The company will host a quarterly conference call on the same day at 14:00 CEST/8:00 AM EST, featuring presentations from key executives including CEO Søren Tulstrup and CFO Evan Ballantyne. The call will provide a comprehensive review of the interim results along with a business and pipeline update. The event will be conducted in English, and presentation slides will be available on the Hansa Biopharma website.
Interested participants can join the call using the provided dial-in details for Sweden, the UK, and the US, or access the live webcast through the company's event webpage.
Hansa Biopharma has increased its registered share capital and the number of shares and votes. The company issued 2,305,260 new ordinary shares, raising the number of votes by the same amount and increasing the share capital by SEK 2,305,260.
Additionally, all 2,362,445 issued class C shares were converted into ordinary shares to deliver ordinary shares to participants in Hansa's incentive programs and to cover social contributions resulting from these programs.
As of June 28, 2024, Hansa Biopharma's total number of registered shares stands at 67,814,241, all of which are ordinary shares. Correspondingly, the number of votes also totals 67,814,241, and the registered share capital amounts to SEK 67,814,241.
Hansa Biopharma (HNSA) has completed the randomization phase in its pivotal Phase 3 US ConfIdeS trial. This trial evaluates the efficacy of imlifidase in kidney transplantation for highly sensitized patients. The trial involves 64 patients and is conducted across 24 US sites. The primary endpoint is kidney graft function at 12 months, measured by eGFR. Data from this trial will support a Biologic License Application (BLA) to the FDA, expected in H2 2025. Imlifidase, already conditionally approved in Europe under IDEFIRIX® for similar indications, is also being explored for autoimmune diseases and as a pre-treatment in gene therapy.
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