OSR (OSRH) FDA Approvals $0.46 +0.01 (+1.56%) As of 10:23 AM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFinancialsHeadlinesOwnershipSEC FilingsTrendsBuy This Stock OSR's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by OSR (OSRH). Over the past two years, OSR has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as VXM01. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. VXM01 FDA Regulatory Events VXM01 is a drug developed by OSR for the following indication: patients with recurrent glioblastoma. 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. Analysis - August 3,2026Analysis Drug: VXM01Announced Date: August 3, 2026Indication: patients with recurrent glioblastoma.AnnouncementOSR Health, Inc. announced that its subsidiary Vaximm AG has completed the analysis of results from two clinical studies evaluating VXM01, an oral DNA vaccine targeting the vascular endothelial growth factor receptor 2 (VEGFR-2), in patients with recurrent glioblastoma.AI SummaryOSR Health, Inc. announced that its subsidiary, Vaximm AG, has completed its analysis of two clinical studies evaluating VXM01 in patients with recurrent glioblastoma. The studies tested the oral DNA vaccine alone and in combination with checkpoint inhibition. VXM01 is designed to activate T cells against VEGFR-2, a protein that helps tumors form new blood vessels and may contribute to immune suppression in the tumor environment. Prof. Wolfgang Wick of Heidelberg University, the trials’ principal investigator, said the results were encouraging and supported further clinical development of the treatment approach. The company plans to submit the findings to a peer-reviewed medical journal once the publication process allows. OSR Health also expects to release additional top-line results and provide more information about the future development of VXM01 and its broader vaccine platform.Read Announcement OSR FDA Events - Frequently Asked Questions Has OSR received FDA approval? As of now, OSR (OSRH) has not received any FDA approvals for its therapy in the last two years. What drugs has OSR submitted to the FDA? In the past two years, OSR (OSRH) has reported FDA regulatory activity for VXM01. What is the most recent FDA event for OSR? The most recent FDA-related event for OSR occurred on August 3, 2026, involving VXM01. The update was categorized as "Analysis," with the company reporting: "OSR Health, Inc. announced that its subsidiary Vaximm AG has completed the analysis of results from two clinical studies evaluating VXM01, an oral DNA vaccine targeting the vascular endothelial growth factor receptor 2 (VEGFR-2), in patients with recurrent glioblastoma." What conditions do OSR's current drugs treat? Currently, OSR has one therapy (VXM01) targeting the following condition: patients with recurrent glioblastoma.. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Acurx Pharmaceuticals FDA EventsAkebia Therapeutics FDA EventsAltimmune FDA EventsEstrella Immunopharma FDA EventsNiagen Bioscience FDA EventsOmeros FDA EventsOSR FDA EventsRocket Pharmaceuticals FDA EventsTonix Pharmaceuticals FDA EventsZai Lab FDA EventsEli Lilly and Company FDA EventsClearPoint Neuro FDA EventsMoleculin Biotech FDA EventsAprea Therapeutics FDA EventsCapricor Therapeutics 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 Cypherpunk Technologies FDA Events Xilio Therapeutics FDA Events PMV Pharmaceuticals FDA Events ImageneBio FDA Events Cardiff Oncology FDA Events Prima BioMed FDA Events Inovio Pharmaceuticals FDA Events Context Therapeutics FDA Events Mereo BioPharma Group FDA Events MiNK Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:OSRH last updated on 8/3/2026 by MarketBeat.com Staff. 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Analysis - August 3,2026Analysis Drug: VXM01Announced Date: August 3, 2026Indication: patients with recurrent glioblastoma.AnnouncementOSR Health, Inc. announced that its subsidiary Vaximm AG has completed the analysis of results from two clinical studies evaluating VXM01, an oral DNA vaccine targeting the vascular endothelial growth factor receptor 2 (VEGFR-2), in patients with recurrent glioblastoma.AI SummaryOSR Health, Inc. announced that its subsidiary, Vaximm AG, has completed its analysis of two clinical studies evaluating VXM01 in patients with recurrent glioblastoma. The studies tested the oral DNA vaccine alone and in combination with checkpoint inhibition. VXM01 is designed to activate T cells against VEGFR-2, a protein that helps tumors form new blood vessels and may contribute to immune suppression in the tumor environment. Prof. Wolfgang Wick of Heidelberg University, the trials’ principal investigator, said the results were encouraging and supported further clinical development of the treatment approach. The company plans to submit the findings to a peer-reviewed medical journal once the publication process allows. OSR Health also expects to release additional top-line results and provide more information about the future development of VXM01 and its broader vaccine platform.Read Announcement
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