April 2 (Reuters) - XBiotech Inc ::1 ANTIBODY TARGETING ADVANCED CANCER.1 MONOCLONAL ANTIBODY, 12D7.HAS OBTAINED AN EXCLUSIVE, WORLDWIDE LICENSE FROM CT ATLANTIC AG.
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Sept 15 (Reuters) - XBiotech Inc :XBiotech - on Sept 14, although there were advancements in certain areas of application European Medicines Agency has maintained its May 18, 2017 opinion.XBiotech says EMA's opinion maintained following re-examination of its Marketing Authorization Application for its lead product candidate in EUROPE- SEC filing.
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June 9 (Reuters) - XBiotech Inc ::XBiotech announces discontinuation of phase III study for colorectal cancer based on second interim analysis.IDMC had no safety concerns from unblinded analysis.Committee recommended early termination of phase III study for colorectal cancer as findings not sufficient to meet efficacy or threshold.Findings will not affect efforts to pursue approval of therapy based on successful completion of European study.In coming weeks, plans to analyze data to further understand primary & secondary endpoint data relating to phase III study for colorectal cancer.
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May 18 (Reuters) - Xbiotech Inc :Xbiotech - received negative opinion from EMA CHMP for marketing authorization application for its lead product candidate in Europe.Xbiotech - co plans to promptly notify EMA of its request for a re-examination and will have 60 days to submit its grounds for appeal - SEC filing.
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April 20 (Reuters) - Xbiotech Inc ::Xbiotech announces outcome of ema's oral explanation meeting.European Medicines Agency rendered negative "trend" vote related to co's MAA for its candidate antibody for treatment of colorectal cancer.Xbiotech Inc-unlikely positive committee for medicinal products for human use opinion related to co's maa will be attained at formal decision vote scheduled in may.
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XBiotech Inc : XBiotech announces top-line results for 514G3 antibody therapy in serious staphylococcus aureus infections . XBiotech Inc - no drug-related adverse events were observed at any of dose escalation levels for 514G3 antibody therapy . XBiotech Inc - total of 28 SAES in 15 patients were reported during study period including 4 deaths . XBiotech Inc - "although deaths observed in treatment arm of study did not appear to be drug-related, this will warrant careful evaluation in larger studies" .XBiotech Inc - four deaths occurred in treatment arm versus none in placebo group in study.
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Xbiotech Inc : Xbiotech announces on-time submission to the ema .Xbiotech - completed on time and confirmed receipt of its march 22, 2017 submission of responses to remaining ema queries related to its maa.
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Xbiotech Inc : Xbiotech announces registered direct offering of common shares . Xbiotech - entered into definitive agreements to sell an aggregate of approximately US$31 million of common shares in a registered direct offering . Xbiotech - net proceeds of offering will be used primarily for continued development of Xbiotech's clinical programs, among others .Xbiotech - transaction was completed from company's shelf registration at $13 per share.
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XBiotech Inc : XBiotech announces successful completion of EMA GMP inspection . Says findings allow french agency to recommend to EMA xBiotech's current facility for commercial manufacture of xilonix .XBiotech inc - company expects EMA decision on marketing application as early as end of 2016.
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Xbiotech Inc :Files for stock shelf of up to 7 million common shares - SEC filing.
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