XBiotech (XBIT) FDA Approvals $1.95 -0.04 (-2.01%) As of 03:54 PM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsNews and TrendsOptions ChainOwnershipSEC Filings XBiotech's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by XBiotech (XBIT). Over the past two years, XBiotech has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as XB2001. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. XB2001 (1-BETTER) FDA Regulatory Events XB2001 (1-BETTER) is a drug developed by XBiotech for the following indication: Pancreatic Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Positive Results - October 19,2026Positive Results Phase 2Drug: XB2001 (1-BETTER)Announced Date: October 19, 2026Indication: Pancreatic CancerAnnouncementXBiotech Inc. announced positive final efficacy results from the randomized Phase II portion of the multicenter TASKIN clinical trial.Read Announcement XBiotech FDA Events - Frequently Asked Questions Has XBiotech received FDA approval? As of now, XBiotech (XBIT) has not received any FDA approvals for its therapy in the last two years. What drugs has XBiotech submitted to the FDA? In the past two years, XBiotech (XBIT) has reported FDA regulatory activity for XB2001 (1-BETTER). What is the most recent FDA event for XBiotech? The most recent FDA-related event for XBiotech occurred on October 19, 2026, involving XB2001 (1-BETTER). The update was categorized as "Positive Results," with the company reporting: "XBiotech Inc. announced positive final efficacy results from the randomized Phase II portion of the multicenter TASKIN clinical trial." What conditions do XBiotech's current drugs treat? Currently, XBiotech has one therapy (XB2001 (1-BETTER)) targeting the following condition: Pancreatic Cancer. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Arbutus Biopharma FDA EventsAcumen Pharmaceuticals FDA EventsCognition Therapeutics FDA EventsCorbus Pharmaceuticals FDA EventsDiaMedica Therapeutics FDA EventsGilead Sciences FDA EventsSCYNEXIS FDA EventsSciSparc FDA EventsAbbVie FDA EventsMedtronic FDA EventsTeleflex FDA EventsAchieve Life Sciences FDA EventsBioCryst Pharmaceuticals FDA EventsHeartBeam FDA EventsCardiff Oncology FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Anika Therapeutics FDA Events Rocket Pharmaceuticals FDA Events Bicycle Therapeutics FDA Events Larimar Therapeutics FDA Events Greenwich LifeSciences FDA Events Century Therapeutics FDA Events Q32 Bio FDA Events SAB Biotherapeutics FDA Events Fate Therapeutics FDA Events Galectin Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:XBIT last updated on 10/19/2026 by MarketBeat.com Staff. 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Positive Results - October 19,2026Positive Results Phase 2Drug: XB2001 (1-BETTER)Announced Date: October 19, 2026Indication: Pancreatic CancerAnnouncementXBiotech Inc. announced positive final efficacy results from the randomized Phase II portion of the multicenter TASKIN clinical trial.Read Announcement
