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    XBIOTECH INC - Eine neue Novartis? - 500 Beiträge pro Seite

    eröffnet am 25.04.15 18:50:59 von
    neuester Beitrag 30.01.21 22:32:51 von
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      schrieb am 25.04.15 18:50:59
      Beitrag Nr. 1 ()
      Gegründet 2005

      IPO erfolgt und somit Nasdaq gelistet (XBIT) seit 15.04.15, durch IPO USD 76.0 Mio eingeholt

      http://www.nasdaq.com/press-release/xbiotech-closes-initial-…

      Mit D. Vasella ist der EX CEO Novartis im VR +

      "Für das Jungunternehmen seien unter anderen bereits Nobelpreisträger und Ex-Novartis-Verwaltungsrat Rolf Zinkernagel sowie Thomas Kündig, ein Forschungsleiter am Unispital Zürich, seit Jahren im Hintergrund tätig."

      http://www.handelszeitung.ch/news/daniel-vasella-wird-verwal…

      XBiotech ist in den Bereichen Onkologie, Therapie von Antibiotika-resistenten Erregern, Herz-Kreislauferkrankungen, Dermatologie und Diabetes Typ 2 aktiv, wie der Webseite des Unternehmens zu entnehmen ist. Derzeit werden Patienten für zwei Phase-III-Studie mit dem Prüfmedikament Xilonix zur Behandlung von Kolorektalkrebs sowie für Phase-II-Tests mit RA-18C3 zur Therapie der schweren Hauterkrankung Pyoderma Gangrenosum (Dermatitis ulcerosa) rekrutiert. Der Ansatz des Unternehmens basiert dabei auf menschlichen Antikörpern, die aus der Reaktion des menschlichen Immunsystems stammen.

      http://www.handelszeitung.ch/news/daniel-vasella-wird-verwal…

      Eindrückliche Pipeline welche breit Indikationen abdeckt:
      http://www.xbiotech.com/clinical/index.html
      Vieles in PII, zwei Programme in PIII

      MK aktuell ca. 700 Mio.
      Bisheriger Kursrange 21.67 - 32.50

      Meinungen?
      1 Antwort
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      schrieb am 27.04.15 21:05:45
      Beitrag Nr. 2 ()
      Gutes Investment aber momentan viel zu hoch bewertet.
      1 Antwort
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      schrieb am 27.04.15 22:51:28
      Beitrag Nr. 3 ()
      Antwort auf Beitrag Nr.: 49.655.579 von lunatics am 27.04.15 21:05:45
      Zitat von lunatics: Gutes Investment aber momentan viel zu hoch bewertet.


      Was wäre deiner Meinung nach eine faire Bewertung und warum?
      Avatar
      schrieb am 30.04.15 07:56:30
      Beitrag Nr. 4 ()
      XBiotech Enrolls First Patient Under Revised Protocol for U.S. Phase 3 Registration Study Using Xilonix(TM) for Treatment of Metastatic Colorectal Cancer

      Revised Phase 3 Study Now Open to More Patients With Colorectal Cancer

      AUSTIN, Texas, April 29, 2015 (GLOBE NEWSWIRE) -- XBiotech (XBIT), a leading developer of next-generation True Human(TM) therapeutic antibodies, announced today that it has enrolled the first patient into its revised U.S. Phase 3 study of Xilonix(TM) in metastatic colorectal cancer patients. Xilonix, XBiotech's monoclonal True Human antibody therapy, is designed to block chronic inflammation associated with malignant tumor growth.

      The U.S. Phase 3 study was initially launched in March 2013, and patients were recruited at more than 60 U.S. cancer centers. The Company previously paused the study to propose to the FDA changes in inclusion criteria to allow broader eligibility for cancer patient enrollment. The newly approved protocol enables recruitment of advanced, refractory colorectal cancer patients that includes those who have failed all standard therapies.

      Dr. George Fisher, Principal Investigator of the study and Professor of Medicine, Stanford University School of Medicine, said, "Metastatic colorectal cancer is a devastating disease and one of the leading causes of cancer-related deaths in the world. Patients diagnosed with this disease have limited treatment options, thus new therapies are urgently needed. Xilonix is intended to target the inflammatory environment of tumor cells and in so doing, slow the growth and spread of the cancer while improving the symptoms associated with advanced disease. Preliminary results have been encouraging and the absence of serious side effects would be a welcome change from standard chemotherapy agents."

      John Simard, President and CEO of XBiotech, commented, "We are very pleased to have begun enrollment in this global Phase 3 study of Xilonix in metastatic colorectal cancer under the revised protocol. This is an important milestone for our Xilonix pipeline as well as our True Human antibody therapy platform."

      At the time of the protocol revision, 40 patients had entered the study with approximately equal numbers in each arm. An analysis of the primary and secondary endpoints of the study was conducted, and though statistical significance was unachievable due to the relatively small number of patients (the statistical model was designed for 656 patients), the trends observed were encouraging and suggested continuation of the study.

      http://finance.yahoo.com/news/xbiotech-enrolls-first-patient…
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      schrieb am 19.05.15 15:09:16
      Beitrag Nr. 5 ()
      05.18.15 - XBiotech Secures Approval from Data Safety Monitoring Board to Continue Phase 3 Registration Study in Europe for its Novel Cancer Immunotherapy

      XBiotech (NASDAQ: XBIT), developer of Xilonix anti-cancer therapy for the treatment of colorectal cancer, announced today that the Data Safety Monitoring Board (DSMB) has recommended continuation of the Company’s Phase 3 registration study underway in Europe. The study, launched in March of 2014, is on schedule for completion this year. The DSMB decision follows a pre-scheduled interim review as part of the study plan. The DSMB board consists of an independent panel of medical experts that oversee execution of the study. While a DSMB’s primary responsibilities are related to safety, they also generally evaluate study conduct with respect to good clinical practices and make recommendations concerning continuation, modification or termination of the trial.

      As part of the only planned DSMB review, the group was tasked with assessing what fraction of patients enrolled had completed all endpoints. Normally, not all patients enrolled make it through all the data endpoints. Based on these findings, the DSMB was to make a recommendation for increasing the patient sample size to maintain statistical power of the study. The DSMB made a recommendation for sample size increase that was within expectations and the Company states enrollment remains on pace to meet the completion timelines.

      The primary objective of the double-blinded, placebo-controlled, multi-center study is to assess the effectiveness of Xilonix for treating patients with symptomatic colorectal cancer. Xilonix blocks interleukin-1 alpha (IL-1a), an inflammatory mediator that acts at the site of the tumor to stimulate growth of tumor blood supply and support tumor growth. In addition, IL-1a may aid circulating tumor cells to form new sites of metastasis and also be involved as a messenger in the brain, where it can trigger fatigue, anxiety and metabolic dysregulation seen in advanced cancer. In a previous study at MD Anderson, Xilonix therapy appeared to not only have anti-tumor effects and prolong survival, but also seemed to improve symptoms of muscle loss, fatigue, appetite loss, and pain in patients with advanced cancer.

      In the current study, anti-tumor effect will be measured by assessing the change in these symptoms for patients treated with Xilonix versus those treated with placebo. Reversal of muscle loss will be assessed with a novel type of radiology called dual energy X-ray absorptiometry, or DEXA. Improvement in pain, appetite loss, and fatigue will be measured with a well-established and validated questionnaire that reliably assesses patient well being as reported by patients themselves.

      John Simard, President and CEO of XBiotech, commented, “The DSMB recommendation is indeed an important milestone for our lead oncology therapy. While the DSMB outcome confirms Xilonix’s extraordinary safety profile, this result also demonstrates that our study is being well-executed and proceeding according to plan. We are all looking forward to unblinding this remarkable study later this year.”

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      schrieb am 26.05.15 23:36:18
      Beitrag Nr. 6 ()
      XBiotech Successfully Clones First Anti-Ebola Therapeutic Antibody Product Candidate

      AUSTIN, Texas, May 26, 2015 (GLOBE NEWSWIRE) -- XBiotech (XBIT), the developer of True Human(TM) therapeutic antibodies, announced today that it has successfully isolated and cloned an anti-Ebola product candidate using its True Human antibody discovery platform.

      True Human antibodies are derived directly from human donors that have natural immunity to disease. The anti-Ebola product candidate was developed from a blood donation received earlier this year from a patient who recovered from Ebola infection.

      John Simard, President and CEO of XBiotech, stated, "Our response to the Ebola outbreak has been a very special project in several ways. Our technology offered us the ability to develop a curative therapy to a deadly disease that was ravaging nations and even threatened us here at home; and it offered the potential to develop a therapy with unparalleled speed. What started with selfless donations from Ebola survivors only a few months ago has resulted in a True Human antibody therapeutic candidate that could be used to treat the disease. We are very proud of the capabilities we have developed and are humbled by the potential to address serious unmet medical need at home and abroad."

      Simard continued, "Additionally, the results of our Ebola program further represent how XBiotech's core strength in efficient drug discovery makes the company uniquely capable to quickly respond to disease outbreaks."
      Avatar
      schrieb am 28.05.15 15:06:48
      Beitrag Nr. 7 ()
      XBiotech Launching Phase 1/2 Clinical Study of Novel True Human(TM) Therapeutic Antibody for Treating Serious Infections Due to Staphylococcus Aureus

      AUSTIN, Texas, May 28, 2015 (GLOBE NEWSWIRE) -- XBiotech Inc. (XBIT), a leading developer of next-generation True Human(TM) therapeutic antibodies, announced today that the Food and Drug Administration (FDA) has lifted its clinical hold from the Company's IND, enabling launch of its therapy for S. aureus infections. XBiotech was placed on clinical hold while it worked with the agency to prepare its novel therapy and manufacturing process for human studies. XBiotech will now begin enrollment of approximately 52 patients in a Phase 1/2 randomized, placebo-controlled, dose escalation study, which will evaluate safety and efficacy of the therapy to treat serious S. aureus infections.

      This drug candidate was developed using XBiotech's True Human antibody discovery platform, which involves screening healthy individuals to identify those with natural immunity to specific diseases. The therapy was derived from an individual that harbored natural antibodies capable of neutralizing S. aureus, including drug-resistant strains of the disease. The treatment is being developed to treat all forms of staph infections and will first be tested in patients with life-threatening infections that are present in the blood, known as bacteremia. The antibody is capable of blocking the key mechanism that S. aureus uses to evade the body's immune system. The therapy can thus at once undermine the bacteria's escape mechanism and facilitate its natural clearance by the body's immune system.

      John Simard, the Company's Chief Executive Officer said, "We are grateful to the FDA for working very closely with us to launch the first of our new infectious disease therapies. It would be difficult to overstate the potential impact this new therapy could have on how therapies are developed and used to treat infections. Derived from natural immunity, this true human antibody offers the means to provide safer, more effective treatments that are not susceptible to present forms of drug resistance. Our antibody therapy represents what we foresee as the launch of '21st century antibiotics,' and the coming of age of biotechnology in the area of infectious disease."
      1 Antwort
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      schrieb am 06.06.15 09:45:44
      Beitrag Nr. 8 ()
      Antwort auf Beitrag Nr.: 49.866.412 von Aurum2010 am 28.05.15 15:06:48Guten Morgen miteinander,

      aus meiner Sicht ein spannendes Investment mit viel Luft nach oben.
      Erfahrenes Management, diversifizierte Pipeline, innovative Technologieplattfom!

      Homepage:

      http://www.xbiotech.com/index.html

      Pipeline:



      Laufende, klinische Studien:

      1.A Phase 3 Study to Evaluate Xilonix as an Anticancer Therapy in Patients With Symptomatic Colorectal Cancer:
      https://clinicaltrials.gov/ct2/show/NCT02138422?term=xbiotec…
      Estimated Study Completion Date: September 2015

      2.A Phase III Study of Xilonix in Patients With Advanced Colorectal Cancer (XCITE):
      https://clinicaltrials.gov/ct2/show/NCT01767857?term=xbiotec…
      Estimated Study Completion Date: December 2016

      3.A Study of the Safety and Efficacy of 514G3 in Subjects Hospitalized With Bacteremia Due to Staphylococcus Aureus:
      https://clinicaltrials.gov/ct2/show/NCT02357966?term=xbiotec…
      Estimated Study Completion Date: October 2015

      4.RA-18C3 Therapy for Subjects With Pyoderma Gangrenosum:
      https://clinicaltrials.gov/ct2/show?term=xbiotech&rank=2
      Estimated Study Completion Date: April 2015
      Avatar
      schrieb am 09.06.15 15:07:53
      Beitrag Nr. 9 ()
      XBiotech Appoints Kelly R. Thornburg as Senior Vice President of Operations
      Former Amgen, Inc. Executive Director, Quality Site Head to Lead XBiotech's True Human(TM) Antibody Production and Manufacturing

      AUSTIN, Texas, June 8, 2015 (GLOBE NEWSWIRE) -- XBiotech (Nasdaq:XBIT), the developer of True Human™ therapeutic antibodies, announced today that Kelly R. Thornburg has joined the company as Senior Vice President of Operations. Mr. Thornburg brings more than 30 years of pharmaceutical operations experience to XBiotech, the prior 16 years spent at Amgen, Inc.

      Mr. Thornburg will oversee manufacturing operations for the production of the Company's True Human therapeutic antibodies. Among his duties, Mr. Thornburg will oversee the transition from Phase 3 clinical manufacturing to launch of commercial production. This will include oversight of the completion and validation of XBiotech's commercial manufacturing facility now under construction.

      During Mr. Thornburg's tenure with Amgen he provided strategic and tactical leadership of manufacturing related programs, including interactions with regulatory agencies, resulting in the successful approval of four protein therapeutics including: Kineret® (anakinra), Kepivance® (palifermin), Nplate® (romiplostim), and Prolia® (denosumab). He also worked on Amgen's pipeline products supporting commercialization strategy and regulatory filing activities.

      John Simard, President and CEO of XBiotech, stated, "Instrumental to our vision of redefining the paradigm for antibody therapeutics is our unique manufacturing system. We are replacing the massively complex plant and equipment infrastructure used by other manufacturers with a simple, disposable bioreactor technology. We believe that this will enable commercial-scale production of novel antibodies at a fraction of the cost, and with shorter lead-time and greater production flexibility than normally required. Kelly's significant operational and quality experience gives him an excellent combination of skills necessary to lead our operations as we transition to commercial production. We are all very excited to have Kelly as part of the XBiotech team."

      Mr. Thornburg added, "Having spent the previous 16 years at Amgen, considered one of the pioneers of today's biotechnology industry, I believe that XBiotech possesses many of the same visionary qualities that have been essential to Amgen's success. I greatly look forward to applying my expertise in operations and quality to XBiotech as the Company utilizes its True Human technology platform to redefine how antibodies are discovered, developed and manufactured."

      Prior to joining XBiotech, Thornburg spent 16 years at Amgen where he held a variety of senior level positions. Thornburg served as an Executive Director, Quality Site Head at Amgen's Colorado facility, where he managed all aspects of Amgen's quality functions with responsibility for two protein drug substance manufacturing plants and GMP warehouse facilities. Before that, Thornburg served as Executive Director, Quality Control, where he managed the Quality Control Laboratory function for the Amgen Manufacturing site in Juncos, Puerto Rico.

      - See more at: http://globenewswire.com/news-release/2015/06/08/742823/1013…
      Avatar
      schrieb am 15.06.15 14:11:11
      Beitrag Nr. 10 ()
      XBiotech Announces Publication of Phase 2 Clinical Results for Its True Human(TM) Antibody MABp1 for Treating Acne Vulgaris
      Monotherapy Led to Rapid Improvement in Skin Lesions and Acne-Associated Psychological Symptoms

      AUSTIN, Texas, June 15, 2015 (GLOBE NEWSWIRE) -- XBiotech (Nasdaq:XBIT), the developer of True Human™ therapeutic antibodies, announces positive results from the Company's Phase 2 study of its MABp1 antibody for treating acne vulgaris. Findings are published in the June 2015 issue of Journal of Drugs in Dermatology1. The study concluded that MABp1, due to its unique molecular target, may be a safe and effective means of treating not only inflammatory acne lesions, but also improving feelings of depression and anxiety commonly associated with acne.

      MABp1 is a novel True Human monoclonal antibody that neutralizes interleukin-1 alpha (IL-1α), a potent inflammatory substance naturally produced by the body in minute quantities but which can cause disease when not effectively controlled. Previous studies suggest that IL-1α plays a role in the early stages of acne lesion formation, so the effect of IL-1α blockade with MABp1 on reducing lesion count was assessed. Furthermore, IL-1α signaling in the hypothalamus region of the brain is also known to mediate triggering feelings of anxiety and depression, which are commonly reported by acne patients, suggesting a second potential point of intervention that is unique to MABp1.

      Dr. Michael Stecher, author and Medical Director for XBiotech, said, "The initial response demonstrated in this trial suggests that the novel mechanism of IL-1α blockade may represent a promising new strategy in the treatment of moderate to severe acne. Interestingly, it is the first clinical study to demonstrate a compelling mechanistic link between the physical and mental symptoms of the disease by showing both could be improved by IL-1α inhibition. It may indeed be the first agent that could potentially treat both skin lesions as well as the psychiatric manifestations of this disorder. Further studies using this antibody are warranted in this patient population."

      John Simard, President and CEO of XBiotech, added, "We are very pleased to publish the data from our Phase 2 study of MABp1 in this journal. Not only does it serve to highlight our potential breakthrough therapy for treating acne, it also showcases the remarkably broad applicability of our MABp1 True Human antibody, for which we have shown significant potential to treat the key inflammatory processes that play a role in exacerbation or progression of a wide range of diseases, including colorectal cancer, non-small cell lung cancer, type-2 diabetes and other dermatological indications such as psoriasis and pyoderma gangrenosum."

      In the open-label Phase 2 clinical study, ten patients with moderate to severe acne received three subcutaneous injections of MABp1 monotherapy over a six-week period and were followed for a total of 70 days to assess safety and efficacy endpoints. MABp1 showed excellent tolerability in the study, with no serious adverse events reported and only few mild adverse events. Disease severity, as measured by inflammatory lesion count, improved consistently, with a median 36% reduction by day 56. MABp1 monotherapy also resulted in clinically meaningful improvements in anxiety/depression and body image scores using two clinically validated questionnaires (Hospital Anxiety and Depression Scale (HADS), median score of 6 reduced to 1 on day 56; and Body Image Disturbance Questionnaire (BIDQ), mean overall score improved from 2.3+.09 to 2.1+.01).

      1Carrasco et al., "An Open Label Phase 2 Study of MABp1 Monotherapy for the Treatment of Acne Vulgaris and Psychiatric Comorbidity." J Drugs Dermatol. June 2015;14(6):560-564. The Journal of Drugs in Dermatology is a peer-reviewed publication offering original articles, award-winning case reports, and timely features pertaining to new methods, techniques, and drug therapy in dermatology.
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      schrieb am 24.06.15 16:17:13
      Beitrag Nr. 11 ()
      XBiotech Added to Russell 2000 Index

      AUSTIN, Texas, June 24, 2015 (GLOBE NEWSWIRE) -- XBiotech Inc., (Nasdaq:XBIT), the developer of True HumanTM therapeutic antibodies, announced today that the Company has been added to the Russell 2000 Index, Russell 3000 Index, Russell Global Index, and Russell Microcap Index as part of Russell Investments' annual index rebalance on June 29, 2015. A preliminary list of companies in the Microcap and other indices can be found at www.russell.com/indexes.

      John Simard, CEO of XBiotech, stated, "XBiotech's addition to the Russell 2000 Index is a gratifying milestone for the company following our successful IPO. Inclusion in the Index should serve to increase our exposure among investors and add value for our shareholders. Our mission to discover and deliver new antibody therapies based on natural immunity to disease is nothing short of a paradigm shift in medicine, while our dramatic cost reduction of the manufacturing process is setting new expectations for the cost of drug development. We have received strong support from the investment community to date and inclusion in the Russell Index offers further objective measure of the investment opportunity."

      Russell Investments reconstitutes its indices annually, determining membership for its equity indexes primarily by objective, rules-based market-capitalization rankings and style attributes. Membership in the Russell 2000, which remains in place for one year, is based on membership in the broad-market Russell 3000 Index. Membership in the Russell Indexes means automatic inclusion in the appropriate growth and value style indexes.

      The Indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for both passive and active investment strategies. Russell calculates more than 700,000 benchmarks daily, covering approximately 98% of the investment market globally, 80 countries, and more than 10,000 securities. Approximately $5.7 trillion in assets are benchmarked to Russell Indices.

      About FTSE Russell:

      Russell Indexes is part of FTSE Russell, a leading global index provider. Institutional and retail investors use FTSE Russell index expertise and products extensively. Leading asset owners, asset managers, ETF providers and investment banks use FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives.

      A core set of universal principles guides FTSE Russell index design and management: independent committees of leading market participants inform a transparent rules-based methodology. FTSE Russell is focused on applying the highest industry standards in index design and governance. FTSE Russell is also focused on index innovation and client collaboration as it seeks to enhance the breadth, depth and reach of its offering.

      FTSE Russell is wholly owned by London Stock Exchange Group. For more information, visit www.ftserussell.com.
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      schrieb am 26.06.15 16:07:10
      Beitrag Nr. 12 ()
      Veröffentlichung von Ergebnissen unter http://archderm.jamanetwork.com/article.aspx?articleid=21689…

      Open-Label Trial of MABp1, a True Human Monoclonal Antibody Targeting Interleukin 1α, for the Treatment of Psoriasis
      Kyle M. Coleman, MD1; Johann E. Gudjonsson, MD, PhD2; Michael Stecher,
      JAMA Dermatol. 2015;151(5):555-556. doi:10.1001/jamadermatol.2014.5391

      "MABp1is a true human monoclonal antibody specific for interleukin 1α (IL-1α), a key proinflammatory cytokine involved in sterile inflammation that is abundantly present in psoriatic skin lesions.1 MABp1 differs from previous generations of therapeutic antibodies in that it was cloned from an Epstein-Barr virus–immortalized human B cell that was isolated from an individual with endogenous anti–IL-1α antibodies, and it has not undergone any in vitro affinity maturation.2 Thus, there is potential for decreased antidrug antibody formation, which should lead to a profile of fewer adverse effects and less loss of effectiveness over time."
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      schrieb am 01.07.15 15:34:25
      Beitrag Nr. 13 ()
      XBiotech Conducts Investigators Meeting to Update the Status of Its Phase III Registration Study Underway in Europe

      AUSTIN, Texas, July 1, 2015 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT), the developer of True Human™ therapeutic antibodies, announced today that it held an investigators meeting to update clinicians and support staff on the overall status of the Company's Phase III study in colorectal cancer. The Company is conducting a double-blinded, placebo-controlled registration study of its anticancer agent for the treatment of advanced colorectal cancer. The novel anti-cancer agent, Xilonix™, is being developed with a regulatory path that the Company established in collaboration with the scientific advisory committee of the EMA.

      The potential breakthrough cancer drug is being evaluated under the EMA's "Guideline on Evaluation of Anticancer Medicinal Products in Man," which offers the possibility to establish novel approval endpoints for anti-cancer agents. In advanced cancer, historically only modest tumor responses are seen in a small percentage of the population. The EMA is thus seeking new endpoints and novel agents that will enable the evaluation of anti-tumor therapy based on patient recovery. Thus the EMA has proposed in its guidelines that, "In patients with tumour-related symptoms at baseline, symptom control, if related to anti-tumour effects, is a valid measure of therapeutic activity and may serve as primary endpoints in late line therapy studies."

      The Company's Xilonix therapeutic monoclonal antibody targets the molecular signalling that leads to neoangiogenesis and other processes that support tumor vascularization and growth. However, the same molecular target is known to signal the brain to cause pain, fatigue, anxiety, appetite suppression and hypermetabolic syndrome seen in advanced cancer. Earlier observations of physical recovery that strongly correlated with improved overall survival were unprecedented findings with Xilonix therapy in advanced cancer patients. The results were published in April 2014 in Lancet Oncology. These findings positioned Xilonix to be able to take advantage of the EMA's unique regulatory pathway for anti-cancer drug development.

      The data presented today to investigators summarized the major findings to date. Although the study was not unblinded and only aggregate data were presented, physicians and support staff involved in the study were given an opportunity to gain a better sense of the overall patient performance. The Company explained that the unprecedented nature of the study design means that physicians have little or no idea of what the overall expectations should be for study participants. The Company is providing the blinded data as requested so that physicians and other care givers may be better able to provide patients with expectations for overall outcomes, so that patients may be better informed when deciding whether to participate in this study.

      The following data were presented:

      A total of 220 patients were reported to be currently enrolled in the study. Data were provided relating to patient performance in the study. As of June 15, 2015, the company stated that 183 patients had completed at least one cycle of therapy and 98 patients had baseline and follow-up DEXA and EORTC-QLQc30 data available. It was also reported that 35 patients had dropped out before completing the 8-week treatment regimen, while there were a further 50 patients at various stages of the 8 week treatment regimen. The Company reported that 61 patients (62% of evaluable patients) were considered to have a positive DEXA outcome as defined for the responder endpoint, with an average LBM change of 2.1 ± 2.8 kg (median 1.2 [IQR 0.5 to 2.0] kg). At the time of analysis, there were also 59 patient responders (60% of evaluable patients) according to the EORTC responder definition. There were 93 patients evaluable for RECIST, which included 2 partial responses (PR) and 23 patients with stable disease (SD). The study was also said to be on schedule for completion as planned this year.

      DEXA, or dual-energy X-ray absorptiometry, is a type of X-ray machine that can measure body compartments, and distinguish between bone, fat and lean tissue (i.e. muscle). The DEXA can thus be used to measure non-fat weight gain in patients. EORTC-QLQ30 is a validated questionnaire developed in Europe that is used to accurately record patient reported health status, such as levels of fatigue, pain and appetite. A DEXA and EORTC performance composite was used to identify patient response to therapy. To be a responder individual patients must meet both DEXA and EORTC response criteria. The study has been designed to compare responders in the treatment arm versus the placebo.

      John Simard, XBiotech's CEO, stated, "The observation of recovery in advanced cancer patients treated with Xilonix made it an ideal therapy for us to work with the EMA to pioneer new endpoints for evaluating cancer therapy in advanced disease. It is widely recognized that in the presence of uncontrolled disease, symptom recovery cannot be anticipated. So the EMA's concept to develop cancer therapies around symptom recovery guides us towards developing anticancer agents that are better for the patient. I think this is tremendously insightful and a definite positive force for creating new and better therapies that keep the well being of cancer patients in mind. To date, however, due to toxicities of most agents, few anti-cancer therapies have been demonstrated to facilitate symptom recovery in a controlled study. Xilonix is thus at the crossroads of being a truly breakthrough anti-cancer agent that helps cancer patients feel better while treating their tumors, while Xilonix also sets a historic precedence for the way cancer therapies are conceived and evaluated in the clinic."
      1 Antwort
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      schrieb am 07.07.15 20:38:21
      Beitrag Nr. 14 ()
      Antwort auf Beitrag Nr.: 50.091.084 von Aurum2010 am 01.07.15 15:34:25Heute (schon wieder;)) positive News:

      XBiotech Announces Publication of Clinical Results Supporting Its True Human(TM) Antibody Therapy for Type 2 Diabetes Mellitus

      http://www.4-traders.com/XBIOTECH-INC-20708500/news/XBiotech…
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      schrieb am 23.07.15 13:54:19
      Beitrag Nr. 15 ()
      meint ihr nicht, dass diese aktie zurzeit überbewertet ist und noch verwässern wird während der forschungszeit?
      1 Antwort
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      schrieb am 23.07.15 13:59:39
      Beitrag Nr. 16 ()
      Antwort auf Beitrag Nr.: 50.249.424 von logicalbrain am 23.07.15 13:54:19
      Zitat von logicalbrain: meint ihr nicht, dass diese aktie zurzeit überbewertet ist und noch verwässern wird während der forschungszeit?


      Ob Überbewertet kann ich dir nicht genau sagen, ich finde die Pipeline und den Ansatz jedoch äusserst Interessant und wertig.

      Verwässern werden Sie auf jeden Fall, die Frage ist nur was für News vorher kommen und zu welchen Kursen ;)
      Avatar
      schrieb am 23.07.15 14:15:03
      Beitrag Nr. 17 ()
      finde die pipeline auch äusserst interessant, macht einen guten eindruck. jedoch habe ich noch mühe damit, bei 19 euro einzusteigen.. falls die big news bei der beschleunigten FDA zulassung schon bald anstehen, dann wird die aktie die 19 vermutlich bei weitem übertreffen und sich darüber etablieren. lässt sich die studie jedoch noch 3 jahre zeit, dann seh ich einen einstieg in 2 jahren bei verwässerten einstelligen kursen als den besseren plan..
      5 Antworten
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      schrieb am 23.07.15 14:38:18
      Beitrag Nr. 18 ()
      Antwort auf Beitrag Nr.: 50.249.637 von logicalbrain am 23.07.15 14:15:03
      Zitat von logicalbrain: finde die pipeline auch äusserst interessant, macht einen guten eindruck. jedoch habe ich noch mühe damit, bei 19 euro einzusteigen.. falls die big news bei der beschleunigten FDA zulassung schon bald anstehen, dann wird die aktie die 19 vermutlich bei weitem übertreffen und sich darüber etablieren. lässt sich die studie jedoch noch 3 jahre zeit, dann seh ich einen einstieg in 2 jahren bei verwässerten einstelligen kursen als den besseren plan..


      "Received FDA Fast Track Designations in both colorectal cancer and in vascular disease"
      http://www.sec.gov/Archives/edgar/data/1626878/0001193125151…" target="_blank" rel="nofollow ugc noopener">
      http://www.sec.gov/Archives/edgar/data/1626878/0001193125151…

      Page 7 - Clinical Development
      4 Antworten
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      schrieb am 23.07.15 14:45:08
      Beitrag Nr. 19 ()
      Antwort auf Beitrag Nr.: 50.249.826 von Aurum2010 am 23.07.15 14:38:18link funktioniert leider nicht.. wie lange denkst du denn, dass eine solche beschleunigte FDA prozedur dauert im vergleich zu einer normalen?
      3 Antworten
      Avatar
      schrieb am 23.07.15 14:57:37
      Beitrag Nr. 20 ()
      Antwort auf Beitrag Nr.: 50.249.895 von logicalbrain am 23.07.15 14:45:08
      Zitat von logicalbrain: link funktioniert leider nicht.. wie lange denkst du denn, dass eine solche beschleunigte FDA prozedur dauert im vergleich zu einer normalen?


      Ev. geht folgender Link
      http://investors.xbiotech.com/phoenix.zhtml?c=253990&p=irol-…" target="_blank" rel="nofollow ugc noopener">
      http://investors.xbiotech.com/phoenix.zhtml?c=253990&p=irol-…

      Zu Fast Track:
      https://de.wikipedia.org/wiki/FDA_Expedited_Program
      2 Antworten
      Avatar
      schrieb am 23.07.15 15:02:15
      Beitrag Nr. 21 ()
      Antwort auf Beitrag Nr.: 50.250.003 von Aurum2010 am 23.07.15 14:57:371. link leider nein

      2. link danke ;)

      3. bist du denn investiert und zu welchem kurs wenn ich fragen darf? ;)
      1 Antwort
      Avatar
      schrieb am 23.07.15 15:23:48
      Beitrag Nr. 22 ()
      Antwort auf Beitrag Nr.: 50.250.051 von logicalbrain am 23.07.15 15:02:15
      Zitat von logicalbrain: 1. link leider nein

      2. link danke ;)

      3. bist du denn investiert und zu welchem kurs wenn ich fragen darf? ;)


      Weiss nicht was mit den Links los ist aber Du kannst ja Googlen:

      "Received FDA Fast Track Designations in both colorectal cancer and in vascular disease"

      Ich habe diese Woche verkauft, der Run von 15 auf 21 hat für einen ersten Gewinn gereicht und muss m.M verdaut werden.

      Habe eine neue Order jedoch platziert, etwas tiefer als wir gerade Kurstechnisch stehen.

      Wichtig nächste Woche:
      AUSTIN, Texas, July 15, 2015 (GLOBE NEWSWIRE) -- XBiotech Inc., (NASDAQ:XBIT), the world's leading developer of next-generation True Human™ therapeutic antibodies, will host its inaugural quarterly business update conference call and live webcast on July 28, 2015, at 8:30am Eastern Time. The Company is hosting this quarterly update in the context of its achievement of very significant milestones both in the clinic and with its R&D programs.

      John Simard, President and CEO of XBiotech, stated, "We are eager to provide an update where we can review the remarkable accomplishments we have made over our first quarter as a public company. There is nothing but good news to report and the Company's programs are firing on all cylinders. There is indeed tremendous excitement for our programs in cancer and infectious disease, as well as for our True Human antibody platform. With our strong cash position, excellent runway, advanced-stage assets and impressive commercialization infrastructure, the company represents a very compelling case. We look forward to the update call and invite all interested parties to mark the date."
      Avatar
      schrieb am 28.07.15 12:58:37
      Beitrag Nr. 23 ()
      XBiotech Provides Second Quarter 2015 Corporate and Clinical Update
      Conference Call and Audio Webcast Today at 8:30 a.m. ET

      Recent Highlights:

      Completed initial public offering April 17, 2015

      Enrolled first patient in global Phase 3 study of Xilonix™ for treating metastatic colorectal cancer under revised protocol

      Reported aggregate patient data from ongoing, blinded Xilonix Phase 3 registration study in Europe

      Phase 3 European study on schedule for 2015 Completion

      Reported positive results for first patient treated in clinical study of antibody therapy for life-threatening S. aureus infections

      Peer-reviewed publication of clinical results for True Human™ antibody therapy in both acne vulgaris and type 2 diabetes mellitus

      AUSTIN, Texas, July 28, 2015 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT), the world's leading developer of next-generation True Human therapeutic antibodies, today provided a corporate and clinical update for the second quarter ended June 30, 2015. This marks XBiotech's first time hosting a quarterly investor call and it provides an opportunity to review the significant accomplishments achieved during the Company's first full quarter as a public company.

      John Simard, the Company's Chief Executive Officer, stated, "In the few short months since our IPO, XBiotech has made remarkable advancements across our lead oncology and infectious disease programs. During the quarter, we resumed patient enrollment for our global Phase 3 study of our lead candidate Xilonix for treating metastatic colorectal cancer under a revised patient inclusion criteria designed to accelerate enrollment. We have since begun an aggressive clinical campaign to bring on nearly 200 clinical sites across Europe, North and South America. We also received a positive recommendation from the DSMB to continue our European pivotal study of Xilonix, for which we expect to complete enrollment in 2015. During a recent meeting of our investigators for the European study, we reported summary data to date, based on enrollment of 220 colorectal cancer patients. While the study remains blinded we are encouraged by the fact that a substantial number of patients showed anticipated signs of recovery as defined by an increase in lean body mass, and reductions in pain, fatigue and appetite loss, which were key observations in our previous Xilonix study and together constitute the primary endpoint for this study."

      "In July, we announced very encouraging results for the first patient dosed in our Phase 1/2 clinical study of 514G3, an antibody therapy to treat S. aureus infections. This patient showed significant signs of recovery from life-threatening MRSA bacteremia within 24 hours of receiving our therapy. Clinical results from this study are expected in the first quarter of 2016, and depending on the results, a pivotal trial is planned for 2016. These lead programs represent our core efforts and we believe they will be first to demonstrate the breakthrough potential of our True Human antibody platform."

      Mr. Simard continued, "We also have demonstrated very encouraging clinical results in several other high-need indications, including lung cancer, vascular disease, diabetes, and certain dermatological conditions. Publication of these clinical results continues to underscore the breadth of our opportunity to treat chronic inflammatory disease and we were proud to have two manuscripts accepted by peer-reviewed medical journals during the second quarter – namely the positive results of our Phase 2 study for treating acne vulgaris, as well as similarly positive findings for our pilot study for treating patients with type 2 diabetes."

      Mr. Simard concluded, "Our recent IPO marked an important milestone in the growth of XBiotech as we prepare to transition from clinical development to commercialization with our lead product candidate, Xilonix. To support significant future growth and to accommodate larger-scale manufacturing, we are now nearing completion on a new manufacturing facility, which we expect to begin operations in 2016. From this facility we will be capable of producing several hundred thousand doses of antibody annually. As we strive to advance our pipeline of novel antibody therapies, leveraging our unique manufacturing process represents a key commercialization strategy."

      Significant Upcoming Milestones

      Complete enrollment in the European Phase 3 colorectal cancer study in the third quarter 2015; report top-line data late 2015 or early 2016

      Report results from Phase 1/2 study of 514G3 therapeutic antibody against S. aureus in first quarter 2016

      Complete enrollment and report interim data for global Phase 3 Xilonix study in late 2016

      Complete construction of new manufacturing and begin operations in the second quarter 2016

      Financial Summary

      On April 14, 2015, XBiotech priced its initial public offering of 4,000,000 shares of its common stock at $19.00 per share, for gross proceeds of $76,000,000 before the underwriting discount. The shares began trading on The NASDAQ Global Select Market under the ticker symbol "XBIT" on April 15, 2015.

      As of June 30, 2015, XBiotech had cash and cash equivalents of approximately $117 million, which included net proceeds from its IPO of approximately $70.9 million.

      Conference Call Information

      XBiotech will host a conference call and audio webcast on July 28, 2015, at 8:30 a.m. Eastern Time to discuss its corporate and clinical updates.

      The conference call can be accessed by dialing:

      U.S. toll free: 866-295-6002
      International: 412-455-6209
      Passcode: 86655088
      The audio webcast can be accessed on the Investor Relations section of the XBiotech website at investors.xbiotech.com. The webcast will be archived for 90 days.
      Avatar
      schrieb am 05.08.15 09:37:18
      Beitrag Nr. 24 ()
      Artikel vom 15.07.15

      Krebspatienten sterben oft nicht am Tumor selbst, sondern an der Auszehrung, die er mit sich bringt.

      Auf diese Erkenntnis baut XBiotech. Gegründet wurde das US-Biotech-Unternehmen mit Schweizer Wurzeln 2005 von Medizinnobelpreisträger Rolf Zinkernagel, dem Schweizer Dermatologen Thomas Kündig und vom amerikanischen Biochemiker John Simard. Im Verwaltungsrat sitzt unter anderem der frühere Verwaltungsratspräsident von Novartis Daniel Vasella.

      Schwere Entzündungen sind keine Seltenheit bei Tumorpatienten. Sie werden durch die Reaktion des Immunsystems auf den Krebs ausgelöst und sorgen für neue Blutgefässe, die den hohen Energiebedarf des Tumors decken. Gleichzeitig zerstören sie das umliegende Gewebe und die Knochen, sodass der Krebs wachsen und sich ausbreiten kann. Für die Entzündungen verantwortlich ist das Immunhormon IL-1a. Wird es blockiert, verschwinden auch die Infektionen. XBiotech hat nun einen Antikörper kreiert, der die Hormonausschüttung unterbindet.

      Der Antikörper, der direkt aus Menschen kloniert wurde – was an sich schon ein Durchbruch in der Forschung ist –, zeigte in ersten Versuchen am Menschen bereits Wirkung. Patienten, die vom Krebs ausgezehrt waren, lebten plötzlich beschwerdefrei und auch länger. Der Tumor war zwar nicht weg, das Wohlbefinden konnte aber deutlich verbessert werden. Das ist im Vergleich zu der mit starken Nebenwirkungen verbundenen Chemotherapie ein grosses Plus.

      Die US-Gesundheitsbehörde FDA zeigte sich beeindruckt und hat dem Wirkstoff mit dem Namen Xilonix für weitere klinische Studien ein beschleunigtes Verfahren zugesprochen. Damit müssen weniger Patienten in die künftigen Tests miteinbezogen werden, was die Kosten mindert. Xilonix wird derzeit in einer zulassungsrelevanten Studie (Phase III) bei verschiedenen Krebsarten getestet. Bei weiteren entzündlichen Krankheiten, wie Schuppenflechte, Diabetes und Akne, laufen klinische Phase-II-Studien. Damit die teuren Tests bei Krebs nicht an einem Liquiditätsmangel scheitern, wagte XBiotech im April den Börsengang an die US-Technologiebörse Nasdaq. Dort konnte sie rund 76 Mio. $ sammeln.

      Nur 60% aller Pharmaprojekte in der Phase III schaffen es statistisch gesehen bis zum Markteintritt, und bei XBiotech ist mit weiteren Finanzierungsrunden und damit mit einer Verwässerung des künftigen Gewinns zu rechnen. Für risikofähige Anleger mit dem nötigen medizinischen Fachwissen bietet sich dennoch eine Einstiegsgelegenheit. Die Aktien sind mittlerweile zu einem Preis von 16.88 $ zu haben, was 11% unter dem Ausgabepreis beim Börsengang ist.

      http://www.fuw.ch/article/hot-corner-schmerzfrei/
      Avatar
      schrieb am 07.08.15 15:41:45
      Beitrag Nr. 25 ()
      XBiotech Announces Expansion of Global Phase 3 Registration Study in Europe using Xilonix(TM) for Treatment of Metastatic Colorectal Cancer

      irst Patients Screened in Europe to Mark Worldwide Expansion of U.S. FDA Colorectal Cancer Study

      AUSTIN, Texas, Aug. 7, 2015 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT), the world's leading developer of next-generation True Human™ therapeutic antibodies, announced today it has expanded its "XCITE" cancer study into Europe. XCITE is an FDA Fast Tracked, Pivotal Phase 3 study of its cancer drug Xilonix™ for treatment of metastatic colorectal cancer. Screening has now begun at the Marii Skłodowskiej-Curie Oncology Center in Warsaw, Poland, marking the first patient recruitment site outside the U.S. and the commencement in earnest of the global phase of the FDA study.

      Xilonix™ Colorectal cancer Immunotherapy Treatment Evaluation ("XCITE"), is designed to assess improvement in overall survival of patients in response to monotherapy with XBiotech's True Human™ monoclonal antibody. The double-blinded, placebo controlled study currently has about 98 sites in the United States and with this launch in Poland, will bring on line more than 80 sites across Eastern and Western Europe. The XCITE trial will continue to expand to include nearly 200 clinical sites across 20 countries worldwide including Australia, Canada and South America. As previously disclosed, XBiotech expects to complete enrollment of this study by the end of 2016.

      Dr. Michael Stecher, XBiotech's Medical Director, stated, "Our on-time launch of XCITE into Europe marks an important milestone in our oncology program and signifies we are moving as planned toward completing enrollment by the end of 2016. Since we have been operating another Phase III oncology program in colorectal cancer in Europe, it was important to time the launch of the U.S. FDA study into Europe so as not to compete for patient enrollment. Our clinical operations team has managed to dovetail this important study with impeccable timing to coincide almost precisely with the completion of the European Phase III program. We expect the rapidly escalating engagement we have seen with our European study will now spill over to this new program, which gives us good confidence that we will achieve our enrollment objectives in 2016 as well as report interim survival data around the time of enrollment completion."

      Total enrollment in the XCITE study will consist of 600 patients. The primary objective of the trial is to assess the ability of Xilonix to improve overall survival in patients with metastatic colorectal cancer who have failed standard therapies. The study will also assess progression free survival, tumor response, change in muscle mass and improvements in quality of life. Earlier observations of Xilonix therapy in advanced cancer patients revealed physical recovery that strongly correlated with significant improvements in survival. The results were published in April 2014 in Lancet Oncology. Based on these results, XBiotech received Fast Track designation from the FDA in October 2012 to develop Xilonix as a treatment in the setting of metastatic colorectal cancer.

      To learn more about the XCITE study please visit: www.xcitecolontrial.com
      Avatar
      schrieb am 17.08.15 13:23:38
      Beitrag Nr. 26 ()
      XBiotech Completes Enrollment for Xilonix(TM) Phase III Registration Study in Europe

      AUSTIN, Texas, Aug. 17, 2015 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT), the world's leading developer of next-generation True Human™ therapeutic antibodies, announced today it has completed enrollment of the Company's pivotal, randomized double-blinded placebo controlled Phase III study in Europe of Xilonix™ for the treatment of advanced colorectal cancer. Xilonix, a novel anti-cancer agent, is being developed via a ground-breaking regulatory path that XBiotech established in collaboration with the scientific advisory committee of the European Medicines Agency (EMA). The Phase III program has now met the enrollment objective for study completion and the Company remains on track to announce results by year end.

      Dr. Tamas Hickish, lead investigator of the European program, said, "I believe this study of a completely novel drug will give new insight into how to treat advanced bowel cancer. The innovative approach to target IL-1a is a fascinating concept in the treatment of advanced cancer. The strong enrollment is a reflection of the need for anti-cancer therapies that maintain patient health while treating the disease."

      John Simard, President and CEO, stated, "To get to this point, we brought together a novel manufacturing program, distributed drug across Western and Eastern Europe, and executed a first-of-its-kind multinational clinical study—so I am especially pleased to say that we have completed enrollment of the Phase III study on schedule for a 2015 readout."

      Mr. Simard further stated, "Robust enrollment speaks to the support Xilonix gained among caregivers and patients. Keep in mind that XBiotech has spent less than $9 million for execution of this study."

      The Company's Xilonix therapeutic monoclonal antibody targets the molecular signaling known to stimulate growth of blood vessels and breakdown of connective tissue. The same signals may be involved in metastasis and messaging to the brain to cause pain, fatigue, anxiety, appetite suppression and hypermetabolic syndrome seen in advanced cancer. Earlier observations of Xilonix therapy in advanced cancer patients suggested physical recovery that strongly correlated with significant improvement in survival in colorectal cancer (Hong et al. Lancet Oncology 2014). These findings formed the basis for developing this unique regulatory pathway in Europe in collaboration with the EMA.

      The Phase III trial is evaluating the efficacy of Xilonix in patients with metastatic colorectal cancer that is refractory to standard therapy. The trial design is double-blind, placebo-controlled and randomizes patients (2:1) to Xilonix plus best supportive care (BSC), or to placebo plus BSC. Eligible patients have metastatic colorectal cancer, have progressed on an oxaliplatin- and irinotecan-based regimen and are experiencing symptoms due to their underlying malignancy. The co-primary endpoint of improvement in lean body mass and improvement in quality of life is assessed after eight weeks of therapy, using whole body DEXA scanning for body composition assessment and the validated EORTC QLQ-C30 questionnaire for life quality assessment. The co-primary endpoints were designed to capture important surrogates for anti-cancer treatment effect, especially those that have been found in the past to correlate independently with improved overall survival. After completing assessment of the primary endpoint at eight weeks, patients are eligible to cross over into an open label extension of Xilonix.
      Avatar
      schrieb am 21.08.15 21:23:36
      Beitrag Nr. 27 ()
      XBIT gehört zu den zukünftigen Biotechperlen. Werden bei den ersten sein, die nach dem Crash massivst gekauft werden. Kohle ohne Ende.

      Avatar
      schrieb am 01.10.15 14:50:31
      Beitrag Nr. 28 ()
      XBiotech Receives FDA Fast Track Designation for Its Novel True Human(TM) Therapeutic Antibody for Treating Serious Infections Due to Staphylococcus Aureus

      AUSTIN, Texas, Oct. 1, 2015 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT), the world's leading developer of next-generation True Human™ therapeutic antibodies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its novel True Human monoclonal antibody therapy intended to treat all forms of Staphylococcus aureus infections, including Methicillin-resistant S. aureus (MRSA).

      XBiotech's antibody therapy, known as 514G3, is currently being evaluated in a Phase 1/2 clinical study and was developed from a human donor with natural antibodies effective at neutralizing MRSA and non-MRSA forms of S. aureus. 514G3 knocks out the principle immune evasion mechanism of the bacteria, allowing white blood cells to detect and destroy the bacteria. 514G3 is expected to treat all strains of MRSA and can be used without consideration for strain-specific resistance to various antibiotics. As a True Human monoclonal antibody, 514G3 is expected to be well tolerated without the side effects or risks of antibiotics.

      John Simard, the Company's Chief Executive Officer, said, "Receiving FDA Fast Track Designation highlights the importance for this product candidate to treat life-threatening bacterial infections. We look forward to reporting on further developments as this important program continues to generate clinical findings."
      Avatar
      schrieb am 19.10.15 15:06:57
      Beitrag Nr. 29 ()
      XBiotech Announces Publication of Clinical Results Supporting the Potential of Its True Human(TM) Antibody as a Cardiovascular Therapy

      Results Published in the Journal of Vascular Surgery Suggest Potential to Target Inflammation to Treat Acute Vascular Injury

      AUSTIN, Texas, Oct. 2, 2015 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT), the world's leading developer of next-generation True Human™ therapeutic antibodies, announced publication of clinical results from a Phase 2 open label, randomized, parallel-group, multicenter study examining SFA restenosis in patients following successful percutaneous revascularization. The results, now available online as an "Article in Press" in the Journal of Vascular Surgery, point towards Xilonix's potential as a safe and effective therapy to preserve vessel patency after endovascular intervention. This program has previously been granted Fast Track Designation by the US FDA.

      In the article titled, "A Randomized Phase II Study of Xilonix, a Targeted Therapy Against Interleukin 1 alpha, for the Prevention of Superficial Femoral Artery Restenosis After Percutaneous Revascularization," XBiotech reported that researchers observed tendencies toward improved vessel patency and fewer major adverse cardiovascular events following dosing of MABp1 over a 3-month period.

      Hosam El Sayed, M.D., Ph.D., associate professor of surgery in the Division of Vascular Diseases and Surgery at The Ohio State University Medical Center and lead author, said, "The cardiovascular field has marked many advancements in recent years, and endovascular interventions to treat peripheral arterial disease have saved and improved many lives, however, the natural history of these lesions after intervention appears to be progression to restenosis. Even as initial reports on newer endovascular technologies have reported lower rates of restenosis of arteries in the lower extremities, a systemic pharmacologic approach to prolong the restenosis free duration would be a major step forward for the treatment of these patients."

      John Simard, President and CEO of XBiotech, added, "The pathological role of inflammation in atherosclerosis and acute vascular events is well established. We are excited to provide the first data that a therapeutic antibody may be used as a potentially safe and effective means to reduce restenosis and major adverse cardiovascular events following revascularization."

      The study enrolled a total of 43 patients with symptomatic, peripheral vascular disease. Upon successful percutaneous revascularization, patients were randomized to Xilonix or standard of care. Xilonix was administered intravenously immediately following revascularization, and every 2 weeks intravenously for 3 additional doses, with additional subcutaneous doses administered monthly. The major efficacy endpoints were target vessel restenosis and incidence of major adverse cardiovascular events (MACE). At 3-month follow-up, which covers the intravenous dosing period, a trend toward lower incidence of restenosis (0/22 [0%] vs. 2/21 [10%], p=0.14) and MACE (2/22[9%] vs. 5/21 [24%], p=0.22) was observed in the Xilonix cohort. Adverse events were equally distributed in both arms.

      http://investors.xbiotech.com/phoenix.zhtml?c=253990&p=irol-…
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      schrieb am 12.11.15 08:34:54
      Beitrag Nr. 30 ()
      XBiotech to Provide Third Quarter Business Update

      AUSTIN, Texas, Nov. 5, 2015 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT), the world's leading developer of True Human™ therapeutic antibodies, announced today it will host a conference call and live audio webcast on Thursday, November 12, 2015, at 8:30 a.m. ET, to provide an overview of its corporate and clinical activities. The call will encompass developments during the third quarter ended September 30, 2015.

      Conference Call Information:

      Interested participants and investors may access the conference call by dialing:

      1 (877) 242-7960 (U.S.)
      1 (330) 863-3267 (international)
      Conference ID: 73120913

      An audio webcast will also be accessible via the Investors Relations section of the XBiotech website www.xbiotech.com/about/investors.html. The webcast replay will remain available for 90 days.
      Avatar
      schrieb am 12.11.15 08:35:12
      Beitrag Nr. 31 ()
      XBiotech Announces Positive Results for Its Anti-Ebola Therapeutic Candidates Following Evaluation by USAMRIID

      AUSTIN, Texas, Nov. 9, 2015 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT), the world's leading developer of True Human™ therapeutic antibodies, announced today positive results for its True Human antibody therapeutic against Ebola virus infection. The results were part of the Company's collaborative research with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). USAMRIID tested the Company's recently developed therapeutic antibodies for their ability to neutralize live virus. The results showed that 8 out of 10 of the antibodies tested were able to effectively neutralize the Ebola virus.

      The Company discovered the anti-Ebola therapeutic antibodies from blood donations it received earlier this year from convalescent patients who had recovered from Ebola virus infections. Once infected by the virus, patients who survive develop natural antibodies that can protect against further infection with the virus. The Company thus used blood from individuals recovered from Ebola virus infection to identify natural antibodies that neutralize the virus. The Company claims that the therapeutic antibodies tested by USAMRIID are the only true human therapeutic antibodies developed against the Ebola virus outbreak that peaked in Africa in 2013-2014 and that also infected patients in the USA and Europe. The Company has also already developed production capability for these therapeutic antibodies that could be used in large scale manufacturing.

      Dr. Pamela Glass, Chief, Viral Biology Department, USAMRIID, who supervised the testing of identified antibodies, said, "These studies demonstrate the capability of the True Human platform to identify functional antibodies from survivors of Ebola or any biological agent infection."

      Dr. Sushma Shivaswamy, Vice President of Research and Development at XBiotech, stated, "We launched the discovery program only earlier this year to clone candidate therapeutic antibodies from Ebola-recovered patients. It is gratifying to now confirm that these antibodies indeed neutralize virus, proving again the powerful potential of our True Human antibody platform. Of course these findings today would not be possible without the courageous work from the USAMRIID scientific team, whose work with live Ebola virus confirmed the neutralizing activity of these antibodies. We are eager to make this candidate therapy available to help relieve suffering from this devastating virus."
      Avatar
      schrieb am 12.11.15 08:35:25
      Beitrag Nr. 32 ()
      XBiotech Identifies Positive Donors for Anti-Clostridium difficile Therapeutic Antibody Only Two Weeks After Initial Screening Company to Clone Genes Responsible for Natural Antibody Against C. difficile

      AUSTIN, Texas, Nov. 11, 2015 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT), developer of True Human™ therapeutic antibodies, announced today that it has already identified positive donors for its first anti-Clostridium difficile (C. difficile) product candidate. Just two weeks after initial screening of blood donations from healthy volunteers, XBiotech has identified donors that have antibody reactivity against its targeted moieties on the C. difficile bacteria. Identifying natural antibodies against C. difficile in the healthy population is the first step in the discovery process for True Human therapeutic antibodies. Since it is unknown at the onset whether or not natural antibodies will be present in the healthy population, the Company believes that identifying these antibodies, especially so quickly, is a good indication that they are important in protection against disease.

      John Simard, President and CEO of XBiotech, stated, "Once again, we have demonstrated the remarkable efficiency of our True Human platform to identify leads for the development of natural human antibodies against disease. We look forward to now cloning the anti-C. difficile antibody genes, and potentially advancing a lead antibody toward clinical studies. With our C. difficile program we are attempting to do something quite extraordinary—unlike any other marketed antibody therapy, our goal is to develop the first oral-delivered monoclonal antibody therapy. Gut infection with C. difficile is a dreadful disease that attacks the most vulnerable, including the aged and infirm. An oral antibody therapy in this population could be a very important advance. We look forward to achieving further milestones in this program."

      About C. difficile infection

      C. difficile infection occurs most often in patients—such as those in healthcare settings, especially hospitals or nursing homes—who recently took certain antibiotics or other medications. The incidence of C. difficile infection is higher in certain patient populations, including people 65 years of age or older, and in patients with compromised immune systems due to an underlying disease or from treatment. Recurrence is a major challenge in C. difficile infection, with approximately one-in-four patients experiencing a recurrence after the initial episode, and more than 40 percent of these patients having further C. difficile recurrence.

      Current treatments for C. difficile include stopping treatment with the antibiotic-associated infection, if possible, and treatment with one of a limited number of antibiotics that have anti-C. difficile activity. For patients with severe pain, organ failure or inflammation of the lining of the abdominal wall, surgery to remove the diseased portion of the colon may be the only option. The use of monoclonal antibodies against C. difficile toxin has been investigated in animal models and human clinical trials as an alternative to or in combination with traditional antibiotic therapy as treatment for C. difficile infection.
      Avatar
      schrieb am 12.11.15 08:41:40
      Beitrag Nr. 33 ()
      Satter Newsflow, Kurstechnisch jedoch keinen Einfluss bisher...

      Denke XBIT ist noch nicht wirklich auf dem Radar der dicken Fische, bisher anur 2% Institutionelle Anleger und keine mir bekannten Ratings.

      Heute Third Quarter Business Update, mal schauen ob das Impulse gibt.
      Avatar
      schrieb am 12.11.15 13:23:47
      Beitrag Nr. 34 ()
      XBiotech Provides Third Quarter 2015 Corporate and Clinical Update

      Conference Call and Audio Webcast Today at 8:30 a.m. ET

      Recent Highlights:

      - Completed enrollment of Xilonix's Phase 3 European registration study in CRC
      - Reported encouraging data from ongoing S. aureus Phase 1/2 clinical study
      - Received FDA Fast Track designation for anti-S. aureus antibody
      - Published positive Phase 2 results in cardiovascular therapy
      - Enhanced intellectual property protection for True Human™ discovery engine
      - Initiated discovery program in C. difficile
      - Announced positive results for anti-Ebola candidates in collaboration with USAMRIID
      - Identified positive donors for anti-C. difficile antibodies

      AUSTIN, Texas, Nov. 12, 2015 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT), the world's leading developer of next-generation True Human™ therapeutic antibodies, today provided a corporate and clinical update for the third quarter ended September 30, 2015. The Company's CEO and other key members of XBiotech's management team will provide updates on the company's clinical, R&D and manufacturing operations during this morning's conference call and audio webcast today at 8:30 a.m. ET.

      John Simard, the Company's Chief Executive Officer, stated, "XBiotech has taken great strides to advance and build value across our entire business, including our lead clinical programs in oncology and infectious disease. We've also expanded our research and development pipeline and moved closer to significantly enhancing our manufacturing capabilities to support commercial production of our True Human antibody therapies. During the quarter, we completed patient enrollment for our European Phase 3 study of our lead candidate Xilonix™ for treating metastatic colorectal cancer and remain on track to report top line data from the pivotal trial by the end of this year. Additionally, we expanded our XCITE U.S. colorectal cancer study, which continues to ramp up to an anticipated 200 clinical sites across 30 countries worldwide by early next year. We remain on track to complete enrollment in this global FDA study, for which we also received Fast Track designation, by the end of 2016."

      "At an investigators' meeting in October, we announced very encouraging early results from our ongoing Phase 1/2 clinical study of 514G3, an antibody therapy to treat S. aureus infections. The findings provided compelling evidence that 514G3 may enable elimination of S. aureus by the immune system, based on the ability of treated patients' blood to mediate in vitro clearance of S. aureus. We expect to begin enrolling the randomized, blinded Phase 2 stage of the study in February 2016 and complete the study by May 2016. Our program in S. aureus represents a potential franchise XBiotech can build around infectious disease. In addition to S. aureus, we began working to identify novel monoclonal antibodies against Clostridium difficile (C. difficile) using our True Human discovery platform. C. difficile infection can lead to a potentially devastating colitis. We were proud to announce that we successfully identified C. difficile-reactive blood donors just two weeks after beginning our initial screening. Confirmation of anti-C. difficile antibodies in the donor population is the first, crucial milestone in our discovery process. The presence of these antibodies provides the first empirical evidence that C. difficile antibodies exist in healthy individuals, suggesting that these antibodies work to clear C. difficile infection before it can become clinically relevant—thus providing a strong indicator we are on the right track to finding a C. difficile antibody therapeutic.

      Similar to our successful Ebola program, the speed with which we identified donors harboring anti-C. difficile antibodies speaks to our unique ability to generate novel True Human antibodies in the face of urgent medical need. Contingent on donor availability, we can expect to have therapeutic candidates for anti-C. difficile as early as second quarter 2016."

      Mr. Simard continued, "We continue to publish positive results for all of our key clinical programs and this quarter we announced a publication in the Journal of Vascular Surgery highlighting positive results from a Phase 2 study examining Xilonix in patients undergoing procedures to restore peripheral circulation, for which it also has FDA Fast Track designation. These data point towards Xilonix's potential as a safe and effective therapy to preserve vessel patency after endovascular intervention and builds upon the potential for targeting interleukin-1 alpha for a range of sterile inflammatory diseases."

      Mr. Simard concluded, "We are building infrastructure to support future growth in our pipeline and to accommodate commercial-scale manufacturing. We are now nearing completion on a new manufacturing facility, which we expect to begin operations in 2016 and will produce several hundred thousand doses of antibody per year. The construction progress to expand our manufacturing capabilities, strengthened intellectual property surrounding True Human discovery technology, FDA Fast Track designation along with all the significant advances with R&D and clinical programs made for a very positive third quarter."

      Significant Upcoming Milestones

      - Report top-line data for Pivotal European Phase 3 colorectal cancer study by year end 2015
      - Complete construction of new manufacturing facility in March 2016
      - Complete Phase 1/2 study of 514G3 therapeutic antibody against S. aureus by May 2016
      - Complete enrollment and report interim data for global XCITE Phase 3 Xilonix study in late 2016

      Financial Summary

      On April 14, 2015, XBiotech priced its initial public offering of 4,000,000 shares of its common stock at $19.00 per share, for gross proceeds of $76,000,000 before the underwriting discount. The shares began trading on The NASDAQ Global Select Market under the ticker symbol "XBIT" on April 15, 2015.

      As of September 30, 2015, XBiotech had cash and cash equivalents of approximately $105 million. XBiotech continues to have no debt. XBiotech believes their current cash and cash equivalents on-hand will be sufficient to fund operations through calendar year 2017.

      The conference call can be accessed by dialing:

      U.S. toll free: 877-242-7960
      International: 330-863-3267
      Conference ID: 73120913
      The live audio webcast can be accessed on the Investor Relations section of the XBiotech website at investors.xbiotech.com. The webcast will be archived for 90 days.
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      schrieb am 24.11.15 09:49:17
      Beitrag Nr. 35 ()
      XBiotech Provides Update on Phase III Oncology Study in Europe

      AUSTIN, Texas, Nov. 23, 2015 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT), developer of True Human™ therapeutic antibodies, announced today findings related to enrollment in the study. The Company is reporting that data cleaning has revealed a fewer number of per protocol patients available for primary endpoint evaluation. The Company found 25 patients dropped off study prior to receiving any dosing with drug or placebo. Analysis of patient blood samples also revealed that 14 patients erroneously received either placebo or study drug. In addition, 33 patients completed the study but failed to receive scheduled DEXA scans, properly complete EORTC evaluation, or both. The Company reports that these combined irregularities compromises data from 72 patients in the study.

      While the study was oversampled to accommodate loss of patients due to disease progression prior to 8 week evaluation, oversampling was not performed to accommodate data loss as described above. With the loss of an additional patients, the study will have reduced statistical power to demonstrate the proposed effect. All patient samples and data has not yet been received and analyzed by XBiotech. The final number of patients affected is expected to increase or decrease only slightly by the final analysis.

      John Simard, President and CEO of XBiotech, stated, "These findings relating to the execution of the study is disappointing. We anticipate approximately another 10 days to complete ongoing analysis of patient samples and data. At such time, we will provide an update on our findings. These findings will not necessarily delay the scheduled unblinding or final analysis of the data."

      XBiotech has been conducting two separate Phase III studies in colorectal cancer with different study designs under the Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulatory paths, respectively. This update pertains to the European study, which was developed in collaboration with the EMA. The novel study design is a double-blind, placebo-controlled study that randomizes patients (2:1) to receive Xilonix plus best supportive care, or placebo plus best supportive care. The co-primary endpoints being assessed are change in lean body mass and change in patient reported symptoms from baseline to the 8 week follow up. Improvements in lean body mass are measured using a form of X-ray imaging called DEXA, combined with an assessment of patient well-being with respect to pain, fatigue and/or appetite loss. Specifically, stabilization or a gain in lean body mass at the 8-week follow up combined with improvement or no worsening in two of the latter measures of patient well-being, as measured by the validated EORTC QLQ-C30 questionnaire, enable a patient to be considered a responder for the purposes of the primary endpoint. The co-primary endpoints were designed to capture important surrogates for anti-cancer treatment effect, especially those that have been found in the past to correlate independently with improved overall survival. After completing assessment of the primary endpoint at eight weeks, patients are eligible to cross over into an open label extension of Xilonix.

      The Company's second colorectal cancer study is a global Phase 3 study being conducted under a Fast Track designation from the FDA. This study is randomized 2:1 with patients receiving Xilonix or placebo plus best supportive care. Patients are required to have metastatic colorectal cancer, and have failed regimens including flouropyrimidines, oxaliplatin, and irinotecan. Unlike the EMA trial, symptoms at baseline are not required for entry. Patients continue on study until there is evidence of radiographic progression. The primary endpoint of this study is overall survival, with secondary endpoints of objective response rate, progression free survival, change in lean body mass as measured by DEXA, and improvement in patient reported quality of life using the validated EORTC QLQ C30 questionnaire.

      http://investors.xbiotech.com/phoenix.zhtml?c=253990&p=irol-…" target="_blank" rel="nofollow ugc noopener">
      http://investors.xbiotech.com/phoenix.zhtml?c=253990&p=irol-…

      Sehr peinlich... Das wird heute nicht schön...

      After Hours unter kaum Volumen:
      XBIT $9 (-4.25) -32.08%
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      schrieb am 07.12.15 14:43:50
      Beitrag Nr. 36 ()
      XBiotech Announces Positive Results in European Phase III Study for Its Breakthrough Therapy for Colorectal Cancer

      Company Now Seeking Marketing Authorization With EMA & Other Jurisdictions

      AUSTIN, Texas, Dec. 7, 2015 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT), developer of True Human™ therapeutic antibodies, announced today that it met the primary endpoint in its European Phase III clinical study of Xilonix™, a novel therapy for patients with symptomatic, advanced colorectal cancer. Patients enrolled in the double-blinded, placebo-controlled study had refractory, metastatic colorectal cancer and suffered from cancer-associated symptoms such as fatigue, pain, elevated inflammatory markers, weight loss and reduced physical ability at baseline. Patients were randomized 2:1 to receive either Xilonix therapeutic antibody or placebo, respectively.

      Significantly more patients treated with Xilonix were responders compared to those given placebo. One-third (33%) of the 207 patients randomized to Xilonix treatment met responder criteria, compared to less than one-fifth (19%) of the 102 placebo patients (p=0.009). Based on a modified intent to treat analysis plan, patients with missing endpoint data or those who received Xilonix instead of placebo were considered non-responders. In total, there were 333 patients enrolled in the study. As per the prospective analysis plan, 24 patients who failed to receive either Xilonix or placebo were excluded from analysis.

      Patients were assessed for anti-tumor activity using a novel co-primary endpoint. X-ray imaging was used to quantify change in lean body mass and health status was assessed based on patient-reported outcomes using the European Organization of Research and Evaluation of Cancer instrument (EORTC-QLQ-C30). The study outcome was based on a responder analysis, such that patients with conserved or improved lean body mass and EORTC-QLQ-C30 performance over the treatment period were considered responders. Responder analysis was determined after 4 cycles of therapy (8 weeks). The Company has been developing the responder analysis as a novel surrogate measure of anti-cancer activity.

      The Xilonix therapeutic antibody uniquely blocks the inflammation that is believed to support tumor growth, spread and symptomatic effects of the disease. In the presence of progressive disease, patient condition is known to deteriorate. In the context of an antitumor therapy, the control or reversal of symptoms related to disease is considered to be evidence of anticancer activity and a prognosticator of better survival.

      This study, developed in collaboration with the EMA, represents the first use of such a responder analysis in a controlled study for the development of an anticancer agent. Xilonix is thus the first anticancer agent evaluated using surrogate measures based on conservation of patient health status, and is believed to be the first anticancer therapy to demonstrate an ability to conserve or improve patient health status with treatment.

      The Company plans to proceed with the marketing authorization process with the EMA and other jurisdictions.

      John Simard, CEO of XBiotech, stated, "We are gratified to announce these findings with Xilonix. The ability of Xilonix to help improve the health of patients with cancer has been demonstrated. We look forward to seeking approval to deliver this unprecedented cancer agent to patients."

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      schrieb am 11.02.16 23:19:34
      Beitrag Nr. 37 ()
      02.11.16 - XBiotech Engages in Research for Heart Attack Antibody Therapy

      XBiotech Inc. (NASDAQ: XBIT), developer of True Human™ therapeutic antibodies, announced today the signing of a Material Transfer Agreement (MTA) with Brigham and Women’s Hospital and Massachusetts General Hospital. XBiotech will provide Antibodies to block the inflammatory mediator interleukin 1 alpha while Novartis Pharmaceuticals will provide an interleukin 1 beta antibody to a research team headed by cardiovascular medicine specialist Dr. Peter Libby. The research team will conduct pre-clinical studies to assess the potential of these antibodies to reduce injury to the heart muscle after heart attack and to calm inflammation in atherosclerotic plaques.

      Dr. Libby, a cardiovascular medicine specialist at Brigham and Women’s Hospital (BWH) and the Mallinckrodt Professor of Medicine at Harvard Medical School (HMS), is the principal investigator of the research project. He has authored more than 370 peer-reviewed articles related to his interest in atherosclerosis and preventative cardiology. Dr. Libby’s research includes studying the messengers created by the body that may produce arterial plaque and blockages. Dr. Libby has received research recognitions on four continents including the highest basic research awards from the American Heart Association and American College of Cardiology, the Gold Medal of the European Society of Cardiology, and the Anitchkow award from the European Atherosclerosis Society.

      Dr. Libby stated “I have researched IL-1’s cardiovascular actions for many years, and am excited about the opportunity to be able to inhibit selectively IL-1 isoforms experimentally to define their roles and thus inform the design of future clinical trials targeting IL-1 in cardiovascular diseases.”

      John Simard, the Company’s Chief Executive Officer, commented, “Dr. Libby’s pioneering work to explore the role of inflammation in cardiovascular disease has been inspirational to our endeavors. Indeed the body of evidence he has generated during his remarkable career forms a key basis to XBiotech’s rationale for using its inflammation-blocking antibody therapy to treat vascular disease. This collaboration is intended to extend these observations by evaluating the role of antibody therapy in reducing injury to heart muscle associated with heart attacks.”

      MABp1 has been in a number of human clinical trials. XBiotech has reported that the antibody therapy has shown promising results in a Phase II randomized study, where the therapy was used to reduce major adverse cardiovascular events and restenosis to the blood vessel after revascularization procedures. The therapy has been Fast Tracked by the US FDA for clinical development in this indication. The animal analogue, FLO1 is a monoclonal antibody that neutralizes the same inflammatory target, IL-1a, as MABp1, but specifically targets the murine form of IL-1a. The use of FLO1 allows it to be well tolerated and function within the animal immune system in a way that is analogous to MABp1 in humans.
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      schrieb am 02.03.16 08:25:55
      Beitrag Nr. 38 ()
      XBiotech to Deliver Presentation on Novel Study Design and Phase III Results From European Study on Xilonix(TM) During Meeting at the European Parliament

      USTIN, Texas, March 02, 2016 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT), developer of True Human(TM) therapeutic antibodies, announced today that its Medical Director Michael Stecher, M.D., will be included in a delegation assembled by EuropaColon to present the latest colorectal cancer research and advocacy-related perspective in a meeting at the European Parliament hosted by MEP Dr Alfred Sant.

      EuropaColon is a patient advocacy group that aims to unite patients, caregivers, healthcare professionals, politicians, the media and the public in the fight against colorectal cancer. The meeting at the European Parliament will launch European Colorectal Cancer Awareness Month, an annual initiative held in March now in its ninth prestigious year.

      #ECCAM16 aims to raise awareness of colorectal cancer across Europe about the critical importance of screening and to reduce deaths through early diagnosis with increased knowledge and better understanding of how the disease can be prevented and treated.

      Dr. Stecher's presentation will cover the results of the recently completed Phase III European study for Xilonix(TM), a True Human(TM) monoclonal (IgG1k) antibody, in the treatment of advanced, symptomatic colorectal cancer. In addition, Dr. Stecher will highlight the novel design of the study endpoints which were developed in conjunction with the European Medicines Agency.

      Jola Gore-Booth, Founder and CEO of EuropaColon, commented, "Colorectal cancer is treatable and potentially curable when diagnosed early, making formal population screening programs key in the fight against this disease. It also is critical that patients have access to the latest treatment options, particularly for those with advanced disease who are suffering from symptoms that preclude treatment with currently approved therapies. I am delighted to be able to feature information on an innovative phase III study design at this meeting."

      Dr. Stecher added, "It is important to participate in multidisciplinary efforts to improve colorectal cancer care at all stages, from screening to late-line therapy. As we prepare to submit our Marketing Authorization Application to the European Medicines Agency for Xilonix(TM) in the treatment of advanced colorectal cancer, we're excited to participate in this meeting."

      Every year approximately 470,000 people are diagnosed with colorectal cancer in Europe and half this number will not survive.1 Colorectal cancer is currently the second leading cause of cancer death in Europe2, and the incidence of colorectal cancer is expected to rise 12 percent by 20203. However, a number of European countries still do not have formal population screening programs for colorectal cancer.

      About European Colorectal Cancer Awareness Month

      Launched in 2008 at the European Parliament in Brussels by EuropaColon, European Colorectal Awareness Month (ECCAM) is an annual awareness-raising initiative held in March; coordinated at European level by the organization and by its Member Groups at national level.

      Predominantly organized by EuropaColon's Member Groups, many events have taken place throughout Europe over the years. The political momentum generated by ECCAM also serves as an important advocacy tool and it has notably contributed to the advancement of National Cancer Plans and policies in a number of European countries.

      #ECCAM16 aims to raise the profile and awareness of Colorectal Cancer (also known as Bowel Cancer) across Europe and the critical importance of screening; to reduce deaths through increased knowledge of the risks and better understanding of how the disease can be prevented.

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      schrieb am 04.03.16 14:48:17
      Beitrag Nr. 39 ()
      European Medicines Agency Grants Eligibility for Submission of XBiotech’s Marketing Authorization Application (MAA)

      AUSTIN, Texas, March 04, 2016 (GLOBE NEWSWIRE) -- XBiotech Inc. (XBIT) announced today that the Company has been granted eligibility by the European Medicines Agency (EMA) to submit a Marketing Authorization Application (MAA) for its candidate therapy Xilonix™ for the treatment of advanced colorectal cancer. An MAA contains all relevant clinical, scientific and manufacturing information that describes how a drug works and is manufactured. The MAA is submitted as the first step in the process of seeking approval to sell the drug in the European Union member nations. XBiotech was granted the ability to submit its MAA through the Centralised Procedure and has been assigned Rapporteurs, the highly specialized project managers that will shepherd the MAA through the review process. The Company expects to submit an MAA shortly.

      John Simard, CEO of XBiotech, stated, "We are gratified that our marketing application has been granted eligibility by the European Medicines Agency. We are looking forward to the submission and review process.”

      In a recently concluded Phase III study in the EU, patients treated with the antibody therapy Xilonix had failed all conventional therapies and had inoperable or metastatic disease. Patients were also required to have multiple symptoms of disease—each of which correlated with poor prognosis. Treatment of these advanced colorectal cancer patients indicated that the Xilonix antibody therapy was able to control tumour-related symptoms associated with morbidity and death. Furthermore, the Phase III study indicated that Xilonix therapy appears to lack the frank toxicity of many other anti-cancer agents, and that the therapy may not cause the negative hematological effects that result in immunosuppression, eliminating a troubling toxicity and life-threatening risk factor of other anti-cancer therapies used to treat advanced disease.

      In the advanced cancer patients treated in this recently completed Phase III study for Xilonix, there was a 76% relative improvement in response rate in patients treated with the antibody, as compared to placebo (p=0.0045). Secondary endpoints used in the Phase III study—control of thrombocytosis and systemic inflammation—which are known prognosticators of overall survival, were also significantly improved in the treated patients compared to controls (respectively p=0.003, p=0.004). In addition to these planned analyses, the study revealed a higher incidence of stable disease in the antibody-treated patients, and there were fewer significant adverse events (SAEs) in the treatment arm than in the placebo group.

      The Company believes that the recent and earlier clinical findings to be presented in its MAA provide a compelling case for the clinical benefit of the antibody therapy and establish Xilonix as a groundbreaking therapy for advanced colorectal cancer.

      Few agents are reliably able to mediate durable responses in metastatic disease; and many agents have significant trade-offs in terms of side effects, such that the overall benefit of therapy may be questionable in patients with advanced cancer. Based on novel objective response (OR) criteria, developed by XBiotech in conjunction with the EMA’s Scientific Advice Working Group, XBiotech’s Xilonix was evaluated for its ability to control disease-related symptoms that inversely correlate with survival. The Company believes that using this symptom-based objective response criteria will allow better assessment of overall benefit from therapy in advanced cancer patients.
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      schrieb am 23.03.16 13:36:09
      Beitrag Nr. 40 ()
      XBiotech Announces European Medicines Agency (EMA) Validates Marketing Authorization Application (MAA) for Xilonix™ in the Treatment of Advanced Colorectal Cancer

      AUSTIN, Texas, March 23, 2016 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that the Company’s Marketing Authorization Application (MAA) for Xilonix™, which is intended for the treatment of advanced colorectal cancer, has been validated by the European Medicines Agency (EMA). With this validation, the application process is complete and the EMA’s Committee for Medicinal Products for Human Use (CHMP) will now begin the assessment of Xilonix through the centralized review procedure. If approved through this procedure, Xilonix will be licensed in all EU member states.

      “The MAA for Xilonix is based on a recently completed Phase III double-blind, placebo-controlled clinical study where the antibody therapy met its primary and secondary endpoints in advanced colorectal cancer,” said John Simard, CEO of XBiotech. "The acceptance of our application for review by the EMA is a significant milestone in our oncology program and leads us one step closer towards potentially addressing a serious and growing unmet medical need for patients suffering from advanced colorectal cancer in the European Union. We look forward to continuing to work with the EMA during the review process.”

      The incidence of advanced, symptomatic colorectal cancer is growing globally with economic development and aging demographics. Persons with advanced colorectal cancer are frequently weakened from successive rounds of cytotoxic therapy, and the risk-benefit associated with further therapy is often questionable. Objective response criteria were developed by XBiotech in collaboration with the EMA’s Scientific Advice Working Group and used to establish clinical benefit in a Phase III study of Xilonix. Findings showed a significant improvement in overall response rate for Xilonix-treated patients versus placebo. The objective response criteria consisted of controlling key symptoms (pain, fatigue, appetite loss, and muscle loss) associated with disease progression and prognosis for overall survival. The Company believes that these criteria will allow excellent assessment of overall clinical benefit from therapy in advanced cancer patients.

      +

      AUSTIN, Texas, March 22, 2016 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT), developer of True Human™ therapeutic antibodies, announced today it will host a conference call and live audio webcast on Wednesday, March 30, 2016, at 8:30 a.m. Eastern Time, to provide an overview of its corporate and clinical activities. The call will encompass developments during the fourth quarter and year ended December 31, 2015.
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      schrieb am 04.04.16 09:19:37
      Beitrag Nr. 41 ()
      European Medicines Agency Grants Accelerated Assessment of Marketing Authorization Application for Xilonix(TM), XBiotech's True Human(TM) Therapeutic Antibody Treatment for Advanced Colorectal Cancer

      (GLOBE NEWSWIRE via COMTEX) --- Xilonix poised to be a first-in-class, True Human monoclonal (IgG1k) antibody

      - First to neutralize biological activity of interleukin-1a (IL-1a), developed specifically to treat advanced cancer

      - EMA decision could speed access to Xilonix for EU patients

      AUSTIN, Texas, April 04, 2016 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted accelerated review for Marketing Authorization of Xilonix, the Company's first-in-class True Human monoclonal (IgG1k) antibody treatment for advanced colorectal cancer. The CHMP grants accelerated review for medicines deemed to be of public health importance and that represent therapeutic innovation. The accelerated review procedure allows the CHMP to grant an opinion two months earlier than the normal 210-day procedure. With this action, a decision on Xilonix's approval could come as early as third quarter 2016.

      Xilonix is XBiotech's lead True Human therapeutic antibody and a potential breakthrough for patients with advanced colorectal cancer. Xilonix specifically targets and neutralizes interleukin-1 alpha (IL-1a), a molecule known to promote angiogenesis (the growth and spread of tumors), as well as mediate symptoms such as metabolic dysregulation (e.g., loss of weight and muscle mass), fatigue and anxiety associated with advanced cancer.

      XBiotech recently received validation of its Marketing Authorization Application (MAA) for Xilonix based on results of a Phase III study, which showed a 76% relative improvement in response rate in patients treated with the antibody, as compared to placebo (p=0.0045). Patients treated in the Phase III study had colorectal tumors that were metastatic or inoperable, had failed all recommended forms of chemotherapy and most other forms of therapy, and suffered from symptoms including pain, fatigue, anorexia and wasting. The patients treated in the Phase III study were considered to represent a large patient population that is physically and emotionally exhausted from the disease and treatment-related toxicities.

      "XBiotech is encouraged by CHMP's action to grant accelerated review of Xilonix," said John Simard, Chairman, Chief Executive and founder of XBiotech. "There is an urgency to provide advanced colorectal cancer patients with access to new treatments that have been developed with their specific needs in mind."

      In the U.S., Xilonix has received Fast Track designation by the Food and Drug Administration (FDA) for the treatment of advanced colorectal cancer.

      http://investors.xbiotech.com/phoenix.zhtml?c=253990&p=irol-…
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      schrieb am 12.05.16 16:32:44
      Beitrag Nr. 42 ()
      XBiotech to Provide First Quarter 2016 Business Update on May 18

      AUSTIN, Texas, May 11, 2016 (GLOBE NEWSWIRE) -- XBiotech Inc. (XBIT), developer of True Human™ therapeutic antibodies, announced today that it will host a live conference call and webcast on Wednesday, May 18, 2016, at 8:30 a.m. ET, to provide a quarterly overview for the first quarter ended March 31, 2016.

      Conference Call Information:
      Interested participants and investors may access the conference call by dialing:

      1 (844) 249-9385 (U.S.)
      1 (270) 823-1533 (international)
      Conference ID: 7241703

      A webcast will also be accessible via the Investors Relations section of the XBiotech website investors.xbiotech.com. The webcast replay will remain available for 90 days.
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      schrieb am 06.09.16 05:33:31
      Beitrag Nr. 43 ()
      Antwort auf Beitrag Nr.: 49.643.519 von Aurum2010 am 25.04.15 18:50:59
      http://cdn2.hubspot.net/hubfs/150154/docs/XBiotech_Executive…
      Avatar
      schrieb am 29.01.17 17:22:17
      Beitrag Nr. 44 ()
      Hier nochmal gut zusammengefasst worum es bei XBiotech geht...


      http://m.srf.ch/news/wirtschaft/xbiotech-medikamente-aus-dem…
      Avatar
      schrieb am 29.01.17 17:32:27
      Beitrag Nr. 45 ()
      Stell das nochmal separat ein, nur falls übersehen.

      http://tp.srgssr.ch/p/portal?urn=urn:srf:ais:video:53530ef8-…
      Avatar
      schrieb am 29.01.17 18:06:20
      Beitrag Nr. 46 ()
      Avatar
      schrieb am 29.01.17 20:52:23
      Beitrag Nr. 47 ()
      Danke lieber gnaraloo,
      Ich glaube das es hier um was ganz spannendes geht!
      Vasella ist dabei, Uni Zürich ist dabei, ein Nobelpreisträger ist auch dabei...
      Und werde auch bald bescheiden mit einer kleiner posi dabei sein.
      Ich werde auch recherchieren und hier posten aber heute nicht mehr
      Habe heute als Schweizer der Sieg Federers zu sehr gefeiert.....
      Avatar
      schrieb am 16.02.17 17:46:32
      Beitrag Nr. 48 ()
      Avatar
      schrieb am 21.02.17 18:16:57
      Beitrag Nr. 49 ()
      Avatar
      schrieb am 07.09.17 19:28:38
      Beitrag Nr. 50 ()
      Einstiegschance

      Die Kursreaktion nach der Einstellung der Phase-III-Studie zu Darmkrebs war zu heftig. Die Technologie birgt nach wie vor ein enormes Potential und könnte die Therapie schwerer Erkrankungen revolutionieren. Mir scheint sich jetzt ein Boden ausgebildet zu haben und man kann sich wieder mit der Umsetzung dieser fantastischen Idee Befassen. Ich denke wir werden noch jede Menge aus der Pipeline von Antikörpertherapien in den Bereichen Onkologie, entzündliche Erkrankungen und Infektionskrankheiten hören. :cool:

      XBiotech Announces Presentation of Phase 2 Study Data Evaluating MABp1 for the Treatment of Hidradenitis Suppurativa
      Results of the Randomized Phase 2 Study Evaluating MABp1 for the Treatment of Hidradenitis Suppurati

      AUSTIN, Texas, Sept. 07, 2017 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that results from the investigator sponsored randomized Phase 2 study evaluating XBiotech’s True Human™ antibody, MABp1, as a treatment for Hidradenitis Suppurativa (HS) will be presented at the European Academy of Dermatology and Venereology (EADV) Congress in Geneva Switzerland. The oral presentation titled, “MABp1, a monoclonal antibody targeting interleukin 1 alpha in patients with hidradenitis suppurativa not eligible for adalimumab: results of a phase II randomized clinical trial” will be given by Theodora Kanni, M.D., Ph.D., Attikon University Hospital in Athens Greece, on 14 September 2017 at approximately 2pm local time.
      Prof. Evangelos Giamarellos-Bourboulis, M.D., Ph.D., who supervises the Outpatients Department for HS of the 4th Department of Medicine at Attikon University Hospital in Greece where the study was conducted and also served as the Principal Investigator of the study, commented, “Hidradenitis is a chronic inflammatory disease with devastating morbidity. It is far too common in our clinic and we do not yet have adequate treatments available. We are truly excited about the results of this clinical study and the potential for MABp1 as a therapy. We look forward to sharing this data with the medical community.”
      XBiotech announced topline results earlier this year, reporting that the study met its primary endpoint and demonstrated a significant improvement in HS patients treated with MABp1 compared to control after 12 weeks of therapy (Response rate of 60% vs 10%, respectively (p=0.035)). The 20 patient double-blind, placebo-controlled study was designed to evaluate the safety and efficacy of MABp1, the Company’s True Human antibody targeting interleukin-1 alpha (IL-1α), in patients with HS not eligible for anti-TNF therapy. Patients were randomized 1:1 to receive either MABp1 or placebo every 2 weeks for 12 weeks. Patients in the study underwent primary assessment of efficacy using Hidradenitis Suppurativa Clinical Response (HiSCR) scores at 12 weeks, continued by a follow up phase to assess time to relapse after an additional 12 weeks without therapy. Efficacy measures include assessment of HiSCR scores, a validated method for evaluating efficacy in HS patients, as well as quality of life assessment and ultrasonographic evaluation. Results of the Phase 2 study are planned for publication later this year.
      About Hidradenitis Suppurativa
      Hidradenitis Suppurativa (HS) is a chronic, inflammatory skin disorder affecting areas rich in apocrine glands. Nodules appear in the affected areas and progressively become swollen with spontaneous rupture and release of pus. This process occurs repeatedly leading to formation of deep sinus tracts and painful dermal abscesses 1,2. Therefore, HS is often devastating for patients with significant impact on quality of life 3. The Dermatology Quality Life Index (DQLI) for HS is 8.9, being higher than any other skin disorder 4. Traditional treatments comprise of antibiotics, antiandrogens and surgery. Prevalence rates for HS have been estimated at up to 4%2.
      About True Human™ Therapeutic Antibodies
      Unlike previous generations of antibody therapies, XBiotech’s True Human™ antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.
      About XBiotech
      XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies based on its True Human™ proprietary technology. XBiotech currently is advancing a robust pipeline of antibody therapies to redefine the standards of care in oncology, inflammatory conditions and infectious diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative biotech manufacturing technologies designed to more rapidly, cost-effectively and flexibly produce new therapies urgently needed by patients worldwide. For more information, visit www.xbiotech.com.
      Cautionary Note on Forward-Looking Statements
      This press release contains forward-looking statements, including declarations regarding management's beliefs and expectations that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "would," "could," "expects," "plans," "contemplate," "anticipates," "believes," "estimates," "predicts," "projects," "intend" or "continue" or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties are subject to the disclosures set forth in the "Risk Factors" section of certain of our SEC filings. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
      1 Revuz J. Hidradenitis suppurativa. J Eur Acad Dermatol Venereol 2009; 23: 985-998.
      2 Alikhan A, Lynch PJ, Eisen DB. Hidradenitis suppurativa: a comprehensive review. J Am Acad Dermatol. 2009 Apr;60(4):539-61; quiz 562-3. doi: 10.1016/j.jaad.2008.11.911.
      3 Vasquez BG, Alikhan A, Weaver, AL, et al. Incidence of hidradenitis suppurativa and associated factors: a population-based study of Olmsted County, Minnesota. J Invest Dermatol. 2013 Jan;133(1):97-103. doi: 10.1038/jid.2012.255. Epub 2012 Aug 30.
      4 Révuz JE, Canoui-Poitrine F, Wolkenstein P, et al. Prevalence and factors associated with hidradenitis suppurativa: results from two case-control studies. J Am Acad Dermatol 2008; 59: 695-701.

      Quelle: GlobeNewswire, Inc
      Avatar
      schrieb am 25.01.19 09:38:00
      Beitrag Nr. 51 ()
      Steigt, steigt und steigt. Bin wieder eingestiegen.

      https://seekingalpha.com/article/4235092-xbiotech-strong-ups…
      Avatar
      schrieb am 28.01.19 19:50:25
      Beitrag Nr. 52 ()
      Wir sind drauf und dran das all time high der letzten 1 1/2 Jahre zu schlagen.
      Avatar
      schrieb am 28.01.19 20:57:55
      Beitrag Nr. 53 ()
      Kaum gepostet fällt der Kurs von +7% auf - 9% und erholt sich wieder?
      Avatar
      schrieb am 05.02.19 16:18:02
      Beitrag Nr. 54 ()
      +20%, es läuft!
      1 Antwort
      Avatar
      schrieb am 05.02.19 17:38:23
      Beitrag Nr. 55 ()
      Antwort auf Beitrag Nr.: 59.796.942 von techxxnine am 05.02.19 16:18:02
      Zitat von techxxnine: +20%, es läuft!


      Innerhalb von 2 Stunden auf -1.5% Was geht ihr denn ab!
      Avatar
      schrieb am 07.04.20 19:16:52
      Beitrag Nr. 56 ()
      Bin über den hervorragenden Wert ADMA auf Xbiotech gestoßen u. wegen der gut gefüllten Kasse und der kürzlich verkündeten News eingestiegen
      https://www.wallstreet-online.de/nachricht/12377413-zusammen…

      Warum ist es hier trotzdem noch so ruhig? Überschätze ich die News? Oder sind alle schon bei dem Tender Offer raus?
      XBiotech | 12,54 $
      Avatar
      schrieb am 08.04.20 15:46:56
      Beitrag Nr. 57 ()
      auch noch drinnen. aber eher wegen dem deal mit Janssen.
      XBiotech | 12,23 $
      Avatar
      schrieb am 19.08.20 17:17:29
      Beitrag Nr. 58 ()
      Von dieser Gesellschaft hört man hier seit Monaten nichts, obwohl es doch vorgestern interessante Nachrichten gegeben hat:

      AUSTIN, Texas, Aug. 18, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) hat heute bekanntgegeben, dass es True Human-Antikörper identifiziert hat, die möglicherweise als Therapie gegen SARS-CoV2, das Virus, das COVID-19 verursacht, eingesetzt werden könnten. Das Unternehmen hat diese Antikörper in Zusammenarbeit mit BioBridge Global (der Mutterorganisation des South Texas Blood & Tissue Center und QualTex Laboratories, einem der größten unabhängigen Testlabors in den USA) entdeckt. Für die Zusammenarbeit verwendete BioBridge Global die unternehmenseigene COVID-19-Screening-Technologie von XBiotech, um Blutspender zu identifizieren, die mit dem neuartigen Coronavirus infiziert waren. Dies war Teil eines Programms zur Bereitstellung von Rekonvaleszenten-Plasma zur Behandlung von Patienten mit schweren COVID-19-Infektionen. Im Gegenzug versorgte BioBridge Global XBiotech mit Blutproben von Patienten, die mit COVID-19 infiziert gewesen waren. Für den Antikörperentdeckungsprozess wählte XBiotech Blutproben von Patienten aus, die sich ohne ernsthafte Erkrankung schnell vom Virus erholt hatten – Faktoren, die darauf hinwiesen, dass diese Spender Antikörper hatten, die sie hochwirksam gegen das Virus schützten.

      Erst am 21. Mai 2020 erhielt XBiotech sein Spenderblut und startete sein Entdeckungsprogramm für COVID-19 True Human-Antikörper. Heute verfügt XBiotech über eine Reihe von True Human-Antikörpern, die genau die Fähigkeit des COVID-19-Virus blockieren, infektiös zu sein, und gleichzeitig dem Körper ermöglichen, das Virus auf natürliche Weise zu beseitigen. Dr. Galina Kuzmicheva, Principal Scientist von XBiotech, die das Projekt zur Entdeckung von COVID-19-Antikörpern geleitet hat, kommentierte dies wie folgt: „COVID-19 hat zu beispiellosen Auswirkungen auf unsere Gemeinschaft geführt. Wir freuen uns, unsere einzigartige Entdeckungstechnologie nutzen zu können, um die natürliche Immunität des Menschen schnell zu identifizieren – und zwar in Form von True Human-Antikörpern, die möglicherweise zur Behandlung der Virusinfektion beim Menschen verwendet werden können.“

      XBiotech entdeckt Kandidaten für COVID-19-Therapie | wallstreet-online.de - Vollständiger Artikel unter:
      https://www.wallstreet-online.de/nachricht/12844861-xbiotech…
      XBiotech | 18,81 $
      Avatar
      schrieb am 24.08.20 19:11:36
      Beitrag Nr. 59 ()
      Quelle:http://www.xbiotech.com/

      "Es gibt keine andere Forschungs- oder pharmazeutische Organisation, die mit der Technologie und den Fähigkeiten von XBiotech besser vorbereitet ist, um Antikörpertherapien zu identifizieren und zu entwickeln, die auf der natürlichen Immunität des Menschen beruhen."

      - John Simard, Präsident und CEO
      XBiotech | 20,35 $
      Avatar
      schrieb am 24.08.20 20:52:29
      Beitrag Nr. 60 ()
      XBiotech - Antikörper Therapie mit Blutplasma als Therapie gegen Covid19
      Die Aktie ist anscheinend nicht so bekannt, obwohl über Antikörper so viel berichtet wird.

      Da Antikörper als vielversprechend gegen Covid19 eingesetzt werden sollen, habe ich mich etwas mit der Aktie eingedeckt. Weiss jemand mehr über den Hersteller. Die Marktkap. ist nicht hoch wenn man in der Pipeline nachschaut. Bereits 2 Phase 3 Kandidaten, einige Phase 2 Kandidaten.
      Nur 29 Millionen Aktien, MKap. etwas über 500 Millionen.

      Die letzte gute Nachricht war vom 17.08.20 in USA ist sie heute ca 10 % gestiegen.

      Freue mich wenn hier etwas Leben reinkommt mit den Beiträgen.
      XBiotech | 20,02 $ | im Besitz: Ja | Meinung: kaufen
      Avatar
      schrieb am 25.08.20 14:15:05
      Beitrag Nr. 61 ()
      ich bin gespannt, was der Kurs heute in USA macht..

      Es sind jedenfalls gute Nachrichten:
      https://www.wallstreet-online.de/nachricht/12864830-xbiotech…
      XBiotech | 16,80 € | im Besitz: Ja | Meinung: halten
      1 Antwort
      Avatar
      schrieb am 13.11.20 17:34:56
      Beitrag Nr. 62 ()
      Antwort auf Beitrag Nr.: 64.875.143 von bellaciao am 25.08.20 14:15:05WANN KOMMEN DEN HIER MAL endlich paar gute NEWS?????????????????????:yawn::yawn::yawn:
      XBiotech | 19,31 $
      Avatar
      schrieb am 19.11.20 17:54:33
      Beitrag Nr. 63 ()
      Heute gab es mal wieder Nachrichten:

      XBiotech Data Shows Effective Anti-Virus Activity for True Human Antibodies in Its Candidate Influenza-COVID-19 Therapeutic Cocktail
      Donnerstag, 19.11.2020 14:15 von GlobeNewswire - Aufrufe: 53

      AUSTIN, Texas, Nov. 19, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) announced today new data for its breakthrough candidate therapy for treating infections of influenza and COVID-19. The Company continues to analyze components of its so-called FLUVID™ therapy as it develops manufacturing capability for a product candidate. The True Human antibodies targeting the virus causing COVID-19 were found to effectively neutralize a test virus at concentrations about four-times better than the antibodies the FDA is now considering for emergency use authorization. Ongoing research has also found that the True Human antibodies in this therapeutic cocktail that target influenza are capable of rescuing 100% of animals that receive an otherwise lethal dose of flu virus. The latest research findings suggest the FLUVID™ therapy, designed to be effective against all known strains of influenza in addition to the COVID-19 virus, could provide a uniquely effective therapy for treating complex infections from one or more of these viruses. There is no other therapy available to treat both COVID-19 and Influenza infections that occur together.

      With the resurgence of the COVID-19 virus during this oncoming flu season, we are faced with the likelihood that many people will be infected by both influenza and COVID-19 viruses. Co-infections, or “superinfections”, may increase severity of disease and further complicate treatment. A therapy that could treat COVID-19+Influenza co-infections is urgently needed.

      While the COVID-19 pandemic has only recently emerged, the FLUVID™ candidate therapy is the result of years of Research and Development at XBiotech, incorporating extraordinary influenza True Human antibodies that have been systematically evaluated for their ability to target virtually all known strains of influenza viruses. Whereas the True Human COVID-19 antibodies were derived from patients who recovered rapidly without serious illness and therefore should have potent neutralizing capability against the virus.

      The influenza strains that will be targeted by FLUVID include: seasonal H1N1 and H3N2 strains; pandemic strains H1N1, H2N2, H3N2; avian influenza strains H5N1, H5N2 and H7N9; and even H9N2 and H10N8, which are currently in poultry but are believed to have pandemic potential in humans.

      Dr. Sushma Shivaswamy, Ph.D., XBiotech’s Chief Scientific Officer, commented, “We continue to see outstanding data as we move this unique and critical therapy toward the clinic. Unlike any other Research and Development program, our pipeline is focused on delivering therapies to the vulnerable demographic that is most in need of the FLUVID™ therapy. We believe strongly in the potential of this product candidate.”

      About XBiotech
      XBiotech is a fully integrated, global biopharmaceutical company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies. XBiotech currently is advancing a pipeline of therapies based on harnessing naturally occurring antibodies from patients with immunity to certain diseases. The approach to use natural human immunity as a source of new medicines offers the potential to redefine the standards of care a wide range of diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative manufacturing technology to reduce the cost and complexity of biological drug production. For more information, visit www.xbiotech.com.

      About True Human™ Therapeutic Antibodies
      XBiotech’s True Human™ antibodies are the only available antibodies derived without modification from humans who possess natural immunity to certain diseases. (Unlike all commercially available antibodies, which are called “Humanized” or “Fully Human”, XBiotech’s True Human™ antibodies are directly sourced from the natural human immune response for specific diseases without modification, and thereby have not been shown to cause immunogenicity.) With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.

      Cautionary Note on Forward-Looking Statements
      This press release contains forward-looking statements, including declarations regarding management's beliefs and expectations that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "would," "could," "expects," "plans," "contemplate," "anticipates," "believes," "estimates," "predicts," "projects," "intend" or "continue" or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties are subject to the disclosures set forth in the "Risk Factors" section of certain of our SEC filings. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

      Contact
      Ashley Otero
      aotero@xbiotech.com
      512-386-2930
      XBiotech | 19,32 $
      Avatar
      schrieb am 20.11.20 17:28:06
      Beitrag Nr. 64 ()
      ...warum schmiert sie ab bei solchen News..???
      XBiotech | 18,67 $
      Avatar
      schrieb am 30.01.21 22:25:48
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      schrieb am 30.01.21 22:28:45
      !
      Dieser Beitrag wurde von CloudMOD moderiert. Grund: Kopie aus fremden Medien- bitte nachlesen unter 9.5. Nutzungsbedingungen: "Wie zitiere ich richtig"
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      schrieb am 30.01.21 22:29:40
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      Dieser Beitrag wurde vom System automatisch gesperrt. Bei Fragen wenden Sie sich bitte an feedback@wallstreet-online.de
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      schrieb am 30.01.21 22:30:38
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      schrieb am 30.01.21 22:31:49
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      schrieb am 30.01.21 22:32:51
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