Valion Bio, Inc. Common Stock (VBIO) FDA Approvals $0.85 0.00 (0.00%) As of 05/22/2026 04:00 PM Eastern Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesOwnershipSEC FilingsShort InterestTrendsBuy This Stock Valion Bio, Inc. Common Stock's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Valion Bio, Inc. Common Stock (VBIO). Over the past two years, Valion Bio, Inc. Common Stock has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Entolimod. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Entolimod FDA Regulatory Events Entolimod is a drug developed by Valion Bio, Inc. Common Stock for the following indication: For Gastrointestinal Acute Radiation Syndrome. 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. Provided Update - March 26,2026Provided Update Drug: EntolimodAnnounced Date: March 26, 2026Indication: For Gastrointestinal Acute Radiation SyndromeAnnouncementTivic Health Systems Inc announced it has entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to sponsor and conduct a series of preclinical studies evaluating Entolimod™ for gastrointestinal acute radiation syndrome (GI-ARS).AI SummaryTivic Health Systems announced an agreement with the National Institute of Allergy and Infectious Diseases (NIAID) to sponsor and conduct preclinical studies of Entolimod™ for gastrointestinal acute radiation syndrome (GI-ARS). The program aims to test whether Entolimod can protect GI tissue and reduce radiation-induced mucosal necrosis, a major cause of death after high-dose radiation exposure. The first study will be run at the Armed Forces Radiobiology Research Institute (AFRRI). Research will start in mice and could move to non-human primates if early results show benefit. These studies are intended to generate the preclinical evidence needed to advance development. NIAID will fund and carry out the studies through its non-clinical and preclinical services, covering all study-related costs and giving Tivic access to advanced infrastructure without extra capital outlay. Entolimod is a TLR5 agonist that activates NF-κB signaling and has shown tissue-protective effects in preclinical work, potentially addressing GI damage not targeted by current ARS treatments.Read Announcement Valion Bio, Inc. Common Stock FDA Events - Frequently Asked Questions Has Valion Bio, Inc. Common Stock received FDA approval? As of now, Valion Bio, Inc. Common Stock (VBIO) has not received any FDA approvals for its therapy in the last two years. What drugs has Valion Bio, Inc. Common Stock submitted to the FDA? In the past two years, Valion Bio, Inc. Common Stock (VBIO) has reported FDA regulatory activity for Entolimod. What is the most recent FDA event for Valion Bio, Inc. Common Stock? The most recent FDA-related event for Valion Bio, Inc. Common Stock occurred on March 26, 2026, involving Entolimod. The update was categorized as "Provided Update," with the company reporting: "Tivic Health Systems Inc announced it has entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to sponsor and conduct a series of preclinical studies evaluating Entolimod™ for gastrointestinal acute radiation syndrome (GI-ARS)." What conditions do Valion Bio, Inc. Common Stock's current drugs treat? Currently, Valion Bio, Inc. Common Stock has one therapy (Entolimod) targeting the following condition: For Gastrointestinal Acute Radiation Syndrome. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Eli Lilly and Company FDA EventsAC Immune FDA EventsAgios Pharmaceuticals FDA EventsAssembly Biosciences FDA EventsBriacell Therap FDA EventsBioLineRx FDA EventsFibroBiologics FDA EventsGilead Sciences FDA EventsOncolytics Biotech FDA EventsPharming Group FDA EventsRegeneron Pharmaceuticals FDA EventsAbbVie FDA EventsMerck & Co., Inc. FDA EventsAgenus FDA EventsAdagio Medical 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 Quoin Pharmaceuticals FDA Events Sintx Technologies FDA Events ENDRA Life Sciences FDA Events Intelligent Bio Solutions FDA Events PAVmed FDA Events Beyond Air FDA Events Aethlon Medical FDA Events Nuwellis FDA Events Bluejay Diagnostics FDA Events Lyra Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:VBIO last updated on 3/26/2026 by MarketBeat.com Staff. 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Provided Update - March 26,2026Provided Update Drug: EntolimodAnnounced Date: March 26, 2026Indication: For Gastrointestinal Acute Radiation SyndromeAnnouncementTivic Health Systems Inc announced it has entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to sponsor and conduct a series of preclinical studies evaluating Entolimod™ for gastrointestinal acute radiation syndrome (GI-ARS).AI SummaryTivic Health Systems announced an agreement with the National Institute of Allergy and Infectious Diseases (NIAID) to sponsor and conduct preclinical studies of Entolimod™ for gastrointestinal acute radiation syndrome (GI-ARS). The program aims to test whether Entolimod can protect GI tissue and reduce radiation-induced mucosal necrosis, a major cause of death after high-dose radiation exposure. The first study will be run at the Armed Forces Radiobiology Research Institute (AFRRI). Research will start in mice and could move to non-human primates if early results show benefit. These studies are intended to generate the preclinical evidence needed to advance development. NIAID will fund and carry out the studies through its non-clinical and preclinical services, covering all study-related costs and giving Tivic access to advanced infrastructure without extra capital outlay. Entolimod is a TLR5 agonist that activates NF-κB signaling and has shown tissue-protective effects in preclinical work, potentially addressing GI damage not targeted by current ARS treatments.Read Announcement
