http://streetinsider.com Latest StreetInsider.com News Articles en-us Copyright 2026, StreetInsider.com rss@streetinsider.com (SI RSS) rss@streetinsider.com (SI RSS) Mon, 15 Jun 2026 09:01:05 -0400 http://blogs.law.harvard.edu/tech/rss http://www.streetinsider.com/images/rss_logo.gif http://streetinsider.com 143 28 0 1 2 3 21 22 23 Saturday Sunday http://www.streetinsider.com/Corporate+News/XBiotech+starts+phase+II+trial+of+vilamakitug+for+axial+spondyloarthritis/26645070.html <p>XBiotech Inc. (NASDAQ: XBIT) announced its Investigational New Drug application for a Phase II clinical trial evaluating vilamakitug in patients with active axial spondyloarthritis has completed the FDA's 30-day review period without clinical hold. The company can now proceed with patient enrollment in the United States.</p><p>The V-SPINE study will evaluate 400 mg of vilamakitug administered as 16 weekly subcutaneous injections versus placebo in 150 adult participants with active axial spondyloarthritis. The primary endpoint measures the proportion of participants achieving an ASAS40 response at Week 16. The study includes a 12-week open-label extension where all participants receive vilamakitug.</p><p>Marina Magrey, M.D., serves http://www.streetinsider.com/Corporate+News/XBiotech+starts+phase+II+trial+of+vilamakitug+for+axial+spondyloarthritis/26645070.html Mon, 15 Jun 2026 09:01:05 -0400 XBIT http://www.streetinsider.com/Press+Releases/XBiotech+Launches+Phase+II+Clinical+Trial+Evaluating+Vilamakitug+for+the+Treatment+of+Active+Axial+Spondyloarthritis/26644904.html <p align="center"><em>IND Application for V-SPINE Study Completes 30-Day FDA Review Without Clinical Hold, Clearing Path for U.S. Patient Enrollment</em></p> <p align="justify">AUSTIN, Texas, June 15, 2026 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) today announced that its Investigational New Drug (IND) application for V-SPINE (PT064), a Phase II, double-blind, placebo-controlled, randomized study evaluating the efficacy and safety of vilamakitug in participants with active axial spondyloarthritis, has successfully completed the U.S. Food and Drug Administration’s (FDA) 30-day review period without a clinical hold. The study is now authorized to proceed with patient enrollment in the United States, marking the http://www.streetinsider.com/Press+Releases/XBiotech+Launches+Phase+II+Clinical+Trial+Evaluating+Vilamakitug+for+the+Treatment+of+Active+Axial+Spondyloarthritis/26644904.html Mon, 15 Jun 2026 09:00:00 -0400 XBIT http://www.streetinsider.com/Globe+Newswire/XBiotech+Launches+Phase+II+Clinical+Trial+Evaluating+Vilamakitug+for+the+Treatment+of+Active+Axial+Spondyloarthritis/26644904.html <p align="center"><em>IND Application for V-SPINE Study Completes 30-Day FDA Review Without Clinical Hold, Clearing Path for U.S. Patient Enrollment</em></p> <p align="justify">AUSTIN, Texas, June 15, 2026 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) today announced that its Investigational New Drug (IND) application for V-SPINE (PT064), a Phase II, double-blind, placebo-controlled, randomized study evaluating the efficacy and safety of vilamakitug in participants with active axial spondyloarthritis, has successfully completed the U.S. Food and Drug Administration’s (FDA) 30-day review period without a clinical hold. The study is now authorized to proceed with patient enrollment in the United States, marking the http://www.streetinsider.com/Globe+Newswire/XBiotech+Launches+Phase+II+Clinical+Trial+Evaluating+Vilamakitug+for+the+Treatment+of+Active+Axial+Spondyloarthritis/26644904.html Mon, 15 Jun 2026 09:00:00 -0400 XBIT http://www.streetinsider.com/SEC+Filings/Form++10-Q+++++++XBiotech+Inc.+++++++++++++For%3A+Mar+31/26493778.html si-local-file:///var/storage/secattach/20260514/26493778.html http://www.streetinsider.com/SEC+Filings/Form++10-Q+++++++XBiotech+Inc.+++++++++++++For%3A+Mar+31/26493778.html Thu, 14 May 2026 14:44:00 -0400 O.22987115 XBIT http://www.streetinsider.com/SEC+Filings/Form++10-Q+++++++XBiotech+Inc.+++++++++++++For%3A+Mar+31/26493778.html si-local-file:///var/storage/secattach/20260514/26493778.html http://www.streetinsider.com/SEC+Filings/Form++10-Q+++++++XBiotech+Inc.+++++++++++++For%3A+Mar+31/26493778.html Thu, 14 May 2026 14:44:00 -0400 O.22987115 XBIT 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