Valion Bio, Inc.

VBIO

$2.85

+1.88%

2026-09-04 09:49:36 EDT+$0.05

Healthcare

Biotechnology

NASDAQ

Active Trading

Valion Bio, Inc. operates as a late-stage biopharmaceutical company. Its lead drug candidate is Entolimod, a TLR5 agonist that is in late-stage ...

Recent News of VBIO

Accesswire8/13/2026Neutral

Ukraine's Ministry Of Health Advances Entolimod Review Into Technical Assessment Phase

Potential Fourth-Quarter 2026 Decision Could Mark Entolimod's First National Registration and Open a Pathway to Strategic Stockpiling and Government Procurement Formal review accepted July 22 • Ministry begins technical assessment • Regulatory requirements defined • Potential decision as early as Q4 2026 Near-Term Regulatory Catalyst Formal review underway: Ukraine's Ministry of Health accepted the Entolimod dossier for formal review on July 22, 2026. Technical assessment underway: Ukraine's Ministry of Health has begun technical assessment of the dossier and issued its first round of questions, relating to the physicochemical characterization of the drug product that would be supplied under a potential stockpiling arrangement.

Accesswire8/12/2026Neutral

Valion Bio Announces U.S. Government-Funded Entolimod Studies Targeting Lethal Radiation-Induced GI Injury

AFRRI/NIAID Program to Advance Safety and Therapeutic Studies in Rapid Sequence; Top-Line Therapeutic Data Expected in Early Fall Study drug delivered • IACUC approval secured • Safety study planned to start this week Near-Term Program Milestones Study readiness: Entolimod has been delivered to AFRRI, IACUC approval has been obtained, and study animals are being acclimated ahead of dosing. Dosing will begin this week.

PRNewsWire7/22/2026Neutral

Ukraine Ministry of Health Accepts Entolimod Dossier for Formal Review Under Regulatory Equivalence Pathway

Government acceptance initiates formal regulatory review of Entolimod under Ukraine's Regulatory Equivalency pathway, with a potential review expected in as few as 45- to 60-days. Ukraine Ministry of Health Accepts Entolimod for Formal Review — Following its request for submission, Ukraine's Ministry of Health has accepted Valion Bio's Entolimod regulatory dossier for formal review under the country's Regulatory Equivalence Pathway, initiating the Ministry's scientific and regulatory evaluation.

PRNewsWire7/20/2026Neutral

World-Premier Cancer Center Sheba Medical Center Selects Entolimod for Clinical Trial, Potentially Expanding Valion Bio into the Multi-Billion-Dollar Neutropenia Market

Sheba Medical Center, which is ranked the #7 hospital in the world, has chosen to evaluate and fund a trial of Valion Bio's Entolimod in cancer patients, creating a second clinical development pathway beyond Acute Radiation Syndrome. Highlights Independent Validation — Sheba Medical Center, ranked the #7 hospital in the world, selected Entolimod for clinical evaluation in cancer patients based on its potential to reduce radiation-induced neutropenia and protect healthy tissue during radiation therapy.

PRNewsWire7/14/2026Neutral

Valion Bio Advances Integrated Biodefense and Immunology Platform Through Continued Government Engagement, Domestic Manufacturing and Oncology Expansion

Strategic execution across multiple initiatives positions the Entolimod platform to pursue opportunities in government preparedness, domestic biomanufacturing and oncology supportive care SAN ANTONIO, July 14, 2026 /PRNewswire/ -- Valion Bio, Inc. (Nasdaq: VBIO) ("Valion Bio" or the "Company") is pleased to report across a series of strategic initiatives for its Entolimod program — including continued engagement with U.S. government agencies and allied nations on Acute Radiation Syndrome (ARS) preparedness, a demonstrated 200-fold manufacturing scale-up through its wholly owned subsidiary Velocity Bioworks®, and planned expansion into innovative oncology supportive care. These developments reflect the Company's evolution from a single product candidate into an integrated biotechnology platform.

Accesswire•8/13/2026

Ukraine's Ministry Of Health Advances Entolimod Review Into Technical Assessment Phase

Valion Bio Announces U.S. Government-Funded Entolimod Studies Targeting Lethal Radiation-Induced GI Injury

Ukraine Ministry of Health Accepts Entolimod Dossier for Formal Review Under Regulatory Equivalence Pathway

World-Premier Cancer Center Sheba Medical Center Selects Entolimod for Clinical Trial, Potentially Expanding Valion Bio into the Multi-Billion-Dollar Neutropenia Market

Valion Bio Advances Integrated Biodefense and Immunology Platform Through Continued Government Engagement, Domestic Manufacturing and Oncology Expansion

AFRRI/NIAID Designs Proprietary PBI-BM2.5 Protocol to Evaluate Valion Bio's (NASDAQ: VBIO) Entolimod as the First and Only Treatment for GI-ARS

AFRRI/NIAID partnership and validated animal models significantly derisk regulatory and commercial advancement of Company's lead candidate Positive momentum further positions Entolimod as a potential first and only treatment for GI-ARS, representing a multi-billion-dollar commercial opportunity SAN ANTONIO, June 25, 2026 /PRNewswire/ -- Valion Bio, Inc. (Nasdaq: VBIO) ("Valion Bio" or the "Company") today announced that the Armed Forces Radiobiology Research Institute ("AFRRI"), a division of the U.S. Department of War ("DoW"), in partnership with the National Institute of Allergy and Infectious Diseases ("NIAID"), has completed design of the survival efficacy protocol that will be used to evaluate the Company's lead candidate, Entolimod™, for the treatment of Gastrointestinal Acute Radiation Syndrome ("GI-ARS"). The final AFRRI/NIAID protocol design for Entolimod emanates from the Company's previously announced non-clinical evaluation agreement with NIAID, and closely follows the U.S. House Armed Services Committee's direction to the DoW to develop a resources and fielding plan for prioritizing radiation/nuclear countermeasures that, like Entolimod, are both prophylactic (pre-exposure) and therapeutic (post-exposure).

Valion Bio (NASDAQ: VBIO) Confirms U.S. House Armed Services Committee Initiative to Address Urgent Need for Radiation /Nuclear Countermeasures

Valion Bio (NASDAQ: VBIO) Confirms U.S. House Armed Services Committee Initiative to Address Urgent Need for Radiation /Nuclear Countermeasures

Emanates from the FY27 NDAA process underway in the U.S. Congress Prioritizes radiation/nuclear countermeasures that are both prophylactic (radioprotectant) and therapeutic (radiomitigant) Follows Company's two recent briefings for senior DoW officials regarding its lead candidate, Entolimod, for acute radiation syndrome SAN ANTONIO, June 11, 2026 /PRNewswire/ -- Valion Bio, Inc. (Nasdaq: VBIO) ("Valion Bio" or the "Company") (f/k/a Tivic Health Systems, Inc.), a late-stage biopharmaceutical company, confirmed today that the U.S. House Armed Services Committee's (the "Committee") FY27 National Defense Authorization Act ("NDAA") report directs the Assistant Secretary of Defense for Nuclear Deterrence, Chemical, and Biological Defense Policy and Programs ("ASD (ND-CBD)"), in coordination with the Assistant Secretary of Defense for Health Affairs (ASD (HA)), to develop a resources and fielding plan for prioritizing radiation/nuclear countermeasures that are both prophylactic (pre-exposure) and therapeutic (post-exposure). The Committee's focus on radiation/nuclear countermeasures addresses an important force protection and readiness challenge by emphasizing medical countermeasures that offer both prophylactic as well as therapeutic efficacy.

VALION BIO BRIEFS SENIOR DEPARTMENT OF WAR AND BARDA OFFICIALS IN JOINT ENGAGEMENT ON ENTOLIMOD FOR ACUTE RADIATION SYNDROME

Cross-Agency Discussion Highlights Interest in Oral Formulation as Field-Deployable Medical Countermeasure SAN ANTONIO, May 19, 2026 /PRNewswire/ -- Valion Bio, Inc. (Nasdaq: VBIO), a late-stage innate immunotherapeutics company, today announced that it presented Entolimod for acute radiation syndrome (ARS) to senior officials from the U.S. Department of War and the Biomedical Advanced Research and Development Authority (BARDA) in a joint briefing held on May 14, 2026. The session was Valion Bio's second engagement with senior Department of War officials, following the Company's April 28, 2026, Pentagon briefing on Entolimod.

Neutral

General

VBIO: Neutral

Seeking Alpha•5/14/2026

Valion Bio Inc. (VBIO) Q1 2026 Earnings Call Prepared Remarks Transcript

Valion Bio's Velocity Bioworks Secures Exclusive Commercial License to LarmorBio's BioScan-NMR™ Platform

First Commercial Installation Targeted for July 2026 in San Antonio; Strategic Reference Site Positions Velocity Bioworks at the Forefront of Next-Generation NMR-Based Diagnostics SAN ANTONIO, May 14, 2026 /PRNewswire/ -- Valion Bio, Inc. (formerly Tivic Health Systems, Inc.) (Nasdaq: VBIO), a clinical-stage immunotherapeutics company, today announced that its wholly owned subsidiary, Velocity Bioworks, has entered into an exclusive commercial development and license agreement with LarmorBio, Inc. ("LarmorBio") for LarmorBio's BioScan-NMR™ platform, a next-generation nuclear magnetic resonance (NMR) system. Under the agreement, Velocity Bioworks will host the first commercial deployment of the BioScan-NMR platform, with installation and commissioning at the Company's San Antonio facility targeted for July 2026.

VALION BIO REPORTS FIRST QUARTER 2026 FINANCIAL RESULTS

First Reporting Quarter as Valion Bio Marked by Continued Advancement of the Entolimod Platform, Broader Government Engagement, and Continued Integration of Velocity Bioworks Conference Call to be Held Today at 1:30 PM PT / 4:30 PM ET SAN ANTONIO , May 14, 2026 /PRNewswire/ -- Valion Bio, Inc. (formerly Tivic Health Systems, Inc.) (Nasdaq: VBIO), a clinical-stage immunotherapeutics company, today reported financial results for the three months ended March 31, 2026 — the company's first full reporting quarter under its new corporate identity — and provided a business update on the continued advancement of its Entolimod platform, ongoing engagement with U.S. government agencies, and continued integration of wholly owned manufacturing subsidiary Velocity Bioworks. First Quarter 2026 Highlights and Subsequent Events Completed corporate transformation, including the change of the company's legal name from Tivic Health Systems, Inc. to Valion Bio, Inc. and the change of the company's Nasdaq listing symbol from TIVC to VBIO, consolidating the company's identity as a focused clinical-stage immunotherapeutics platform.

Neutral

General

VBIO: Neutral

Supply Chain of VBIO

RELATIONS

Upstream

Velocity Bioworks (Wholly Owned CDMO Subsidiary)Danaher Corporation (Cytiva)NYSE:DHR Thermo Fisher Scientific Inc.NYSE:TMOSartorius AGETR:SRT3Merck KGaA (MilliporeSigma)ETR:MRKLarmorBio, Inc.Scorpius Holdings, Inc.OTCPK:SCPXStatera Biopharma, Inc.OTC:STABCleveland BioLabs, Inc. (merged into Cytocom/Statera)

Downstream

U.S. National Institute of Allergy and Infectious Diseases (NIAID)U.S. Department of Defense / Defense Threat Reduction Agency (DTRA) / Armed Forces Radiobiology Research Institute (AFRRI)Biomedical Advanced Research and Development Authority (BARDA)Sheba Medical Center (Tel HaShomer, Israel)U.S. House Armed Services Committee

Proxies

Emergent BioSolutions Inc.NYSE:EBS Tonix Pharmaceuticals Holding Corp.NASDAQ:TNXP Aquestive Therapeutics, Inc.NASDAQ:AQST

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