• 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."

    Geld stinkt nicht !

  • 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.
  • Verstehe ich das richtig, das heisst eine allfällige Zulassung von Xilonix durch die FDA ist erst gegen Ende 2016 oder Anfang 2017 zu erwarten?

    Es steht ja in der Nachricht:

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

    Sorry für die Fragerei, bin in dieser Beziehung noch ein Anfänger :)

  • stonekingcold hat am 28.07.2015 - 15:13 folgendes geschrieben:


    Verstehe ich das richtig, das heisst eine allfällige Zulassung von Xilonix durch die FDA ist erst gegen Ende 2016 oder Anfang 2017 zu erwarten?

    Es steht ja in der Nachricht:

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

    Sorry für die Fragerei, bin in dieser Beziehung noch ein Anfänger [Blocked Image: http://www.cash.ch/sites/all/modules/contrib/smiley/packs/kolobok/smile.gif]

    Interim data gegen Ende 2016.

    Die komplette Auswertung der Studie wird noch ein paar Monate länger dauern. Danach muss das Dossier für die Einreichung bei der FDA erstellt werden. Auch dies dauert ein paar Monate.

    Prognose: Bis zur Annahme des Dossiers, sofern die Phase III nicht durchfällt, wird es wohl Ende 2017 werden.

    Weiss nicht ob Xilonix Orpan Drug Status besitzt. Mit Orpan Drug dauert es dann ein paar Monate weniger lang, bis die FDA über eine allfällige Zulassung entscheidet. Vor Mitte 2018 würde ich jedoch nicht mit einem Entscheid rechnen.

    Habe mich noch nicht wirklich mit XBiotech befasst. Sollten meine Angaben Fehler enthalten, lasse ich mich gerne korrigieren.

  • 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


  • Bin anfangs letzter Woche bei 18.90 (glücklicherweise) mit kleinem Verlust raus. Habe mir von den Quartalszahlen mehr Informationsgehalt erwartet. Werde den Titel jedoch weiter im Auge behalten - sehe hier grundsätzlich enormes Potential.

  • Aurum hat am 09.08.2015 - 20:37 folgendes geschrieben:


    War beim letzten Anstieg über 22 raus und bin um 16 wieder rein.

    clever :D

    siehst du denn ein Grund, dass wir so runtergerauscht sind? Klar es dauert noch einige Zeit bis Resultate kommen, aber gerade so extrem? Oder sind hier evt wiedermal die shorties am Werk?

  • stonekingcold hat am 10.08.2015 - 11:04 folgendes geschrieben:


    Auf seeking alpha wurde ein Artikel zu XBIT publiziert. Ich nehme an dieser ist für den Sturz verantwortlich.


    Definitiv - Es wird einem auch "Angst und Bange" wenn man den Artikel liest...
    = Ziel der Short erreicht

    Von 22.xx auf 13.87 ohne negative News seitens XBiotech...
    Denke langsam wieder überverkauft, der Kurs wird wieder drehen.

  • 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.

  • 2brix hat am 17.08.2015 - 16:18 folgendes geschrieben:


    ist doch gut, warum bewegt sich das Ding nicht?!?

    Gute Frage... XBIT macht halt (leider) seinen eigenen Tanz unabhängig von News.

  • Guter Artikel in der Handelszeitung vom 20.8. über XBIT, Vasella im VR hat halbe Kiste investiert, Kursverfall wird den Shortsellern angelastet ... nach Statistik schafft nur 1 Biotech Startup den Durchbruch, darum wird geshortet bis der Arzt kommt ;)

    Sollte das Krebsmedi es nicht schaffen, sind noch weitere Produkte in Erforschung, das würde die Aktie nur ca 50% einbrechen lassen...