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  • Cyxone AB
    Hyllie Boulevard 34, 215 32 Malmö, Sweden
    +46 708882172
    +46 708882172
    https://cyxone.com/en/

    • Quotes

    We are happy to announce the positive study outcomes, an instrumental part of the preparations for the Phase 2 study in RA patients set to start late next year. Equally, we are eagerly looking forward to the imminent initiation of our clinical study of Rabeximod in Covid-19 patients. Combined with the new patent applications recently filed, with potential to substantially prolong market exclusivity, and with a stockpile of drug substance enabling further clinical studies beyond those currently in the pipeline, we stand with a strong foothold in future partnering negotiations. All in all, Cyxone is well-positioned for the development of safe and innovative treatments toward serious immune system disorders.
    Tara Heitner, CEO, Cyxone
    After thorough evaluation, we were able to decide upon this CRO as our partner of choice for these preclinical studies. The selected CRO has an excellent reputation and we got a great impression of their quality and professionalism from the start. We now look forward to take the next step in the development program for our Phase II candidate Rabeximod.
    Malin Berthold, Head of Project Management at Cyxone
    This market maker is now being implemented to increase liquidity of our stock, which has sometimes been low. We look very favorably on this support measure, which is primarily done to benefit our shareholders through reduced trading risks.
    Kjell G. Stenberg, CEO of Cyxone
    The acquisition of Rabeximod is the most important milestone since Cyxone was founded. I have been following Rabeximod's development in OxyPharma for a long time and believe that this investment is very beneficial for our shareholders. We have in a short time been able to build a world-class autoimmune product portfolio, which has permeated the discussions we have had with different stakeholders regarding the financing of Rabeximod's phase IIb study. This is why we are now taking the opportunity to complete the payment and hope to return soon to our shareholders with more positive news regarding Rabeximod.
    Kjell G. Stenberg, CEO of Cyxone
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    Safety confirmation and observed trends in Covid-19 study build further confidence in Cyxone’s rheumatoid arthritis program

    Cyxone AB (publ), the Swedish biotech company that develops disease modifying therapies for diseases such as rheumatoid arthritis (RA) confirms the previously demonstrated favorable safety and tolerability profile for its drug candidate Rabeximod, in the Clinical Study Report from its exploratory phase 2 study in Covid-19 patients. Other observations include a trend showing patients that were given Rabeximod, in comparison to the placebo group, had a higher rate of early release from the hospital. Exploratory endpoints analysis indicated modulation of disease relevant cytokine biomarkers by

    Cyxone presents top-line results from a phase 2 study of Rabeximod in Covid-19 patients

    Cyxone (publ) today announces top-line results from a phase 2 study of Rabeximod in Covid-19 patients with moderate disease. The primary endpoint, ultimately proposed by the FDA, was to document the difference of the proportion of subjects alive and free of respiratory failure at day 28 between placebo (standard of care treatment) and Rabeximod plus standard of care. The topline data analysis showed that almost all patients were alive and free of respiratory failure at day 28 in the different treatment arms. No statistical difference between treatment arms could be observed at day 28, thus

    Cyxone will leverage IND and use FDA pre-review for Covid-19 phase 2 trial

    Cyxone AB (publ) announces today that the company is expecting to communicate top-line results from a recently concluded Phase 2 trial of its drug candidate Rabeximod in Covid-19 patients during the fourth quarter. The results were previously slated for the third quarter. The postponement is due to the company’s decision to leverage the U.S. Food and Drug Administration (FDA) initiative to pre-review the statistical analysis plan for the clinical trial, whereby the exact timing of the results will depend on the process and discussion required with the FDA. This is an extraordinary opportunity

    Cyxone announces Rabeximod in Covid-19 Phase 2 trial closed, data to be reported in Q3

    Cyxone today announced that the Rabeximod in Covid-19 trial that has been conducted in Eastern Europe during Q1-Q2 2021 will be closed as the trial has been shown to have a sufficient number of patients enrolled to allow for statistical analysis.Recently Cyxone reported that patient recruitment for the clinical study conducted in Covid-19 patients in Eastern Europe was challenged as Covid-19 cases declined and a study delay was predicted. Approximately 90 patients have been enrolled into the trial to date, and after reanalysis of the statistical requirements for study size it has been

    Cyxone explores expanding into new regions to mitigate potential delay in Covid-19 trial completion

    Cyxone initiated a clinical trial in Eastern Europe with Rabeximod as a treatment for patients with moderate Covid-19 in January 2021. Approximately 90 patients have been successfully enrolled to date. With the declining number of hospitalized Covid-19 patients in Eastern Europe, Cyxone is now considering opening up trial sites in more countries and has had to push back the projected study readout later than Q3 2021.After discovering that the rheumatoid arthritis drug candidate Rabeximod, could be effective in patients with moderate Covid-19, Cyxone started a Phase 2 clinical trial in

    Cyxone reports first Covid-19 patient screened in Phase 2 clinical trial of Rabeximod

    Cyxone (publ.) announced today that the first patient has been screened in the Phase 2 clinical trial of Rabeximod in Covid-19. The trial will evaluate the efficacy and safety of oral treatment with Rabeximod to prevent disease progression in hospitalized Covid-19 patients and shorten the time to recovery. The study will include 300 patients at clinical centers in Poland, Slovakia and up to three additional countries in Europe. Cyxone expects to announce preliminary results in the third quarter of 2021.Cyxone recently announced that the company had received regulatory approval to initiate a

    Cyxone has filed an IND in the US with Rabeximod following positive feed-back from pre-IND meeting with the FDA

    Cyxone (publ.), a clinical stage biotech company developing first-in-class drugs for diseases of the immune system, announced today that the company has filed an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) pertaining to its drug candidate Rabeximod. The application follows on a productive pre-IND meeting with the authority, where valuable advice was received on inter alia the protocol for its imminent European Phase 2 clinical study in moderate Covid-19. The IND covers the development of Rabeximod in Covid-19 and other indications, such as

    Cyxone receives regulatory approval to initiate a clinical Phase 2 study with Rabeximod in Covid-19 patients

    Cyxone (publ.) announced today it has received approval from the regulatory authority and the ethics committee in Poland to initiate a Phase 2 clinical trial with Rabeximod in moderate Covid-19 patients. The oral treatment is intended to prevent the progression to acute respiratory distress symptoms (ARDS) caused by virus-related overactivation of the immune system. Preliminary results are expected in the third quarter of 2021.Most individuals infected with Covid-19 experience only mild symptoms. However, in some patients there is a risk that the immune system overreacts, triggering a

    Cyxone receives in total SEK 21.8 million in proceeds from fully utilized investment option agreement with Dr. Kalev Kask

    Cyxone AB (publ), a Swedish biotech company dedicated to developing improved treatments for autoimmune diseases, announces today that the investment option agreement with Dr. Kalev Kask has been fully utilized through a third and final utilization of the investment option. The three directed share issues carried out under the agreement brings the company a gross proceed of SEK 21.8 million in total, whereof, SEK 1.8 million has already been received through earlier utilizations. This will cover most of the costs for the planned phase 2 clinical study of Rabeximod in Covid-19 patients. This

    Cyxone plans to initiate a phase 2 clinical trial with Rabeximod in Covid-19 patients

    Cyxone (publ), a Swedish biotech company dedicated to developing improved treatments for autoimmune diseases, announces today that it plans to initiate a phase 2 clinical trial with Rabeximod in Covid-19 patients. The treatment is intended to reduce the risk of developing severe respiratory symptoms caused by virus-related overactivation of the immune system.Most people with Covid-19 experience only mild symptoms, but in severely affected patients the immune system overreacts, triggering a disproportional release of cytokines and chemokines that leads to hyperinflammation and severe

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