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Valion Bio, Inc.
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News: VBIO
Valion Bio Announces Changes to Management and Board of Directors
Current CFO, Lisa Wolf named President and COO, assuming expanded executive and operational leadership. Jared Malbin and Thomas Jensen appointed as directors.
Valion Bio Announces Reverse Stock Split
SAN ANTONIO, TX / ACCESS Newswire / August 27, 2026 / Valion Bio, Inc. (Nasdaq:VBIO) ("Valion Bio" or the "Company) announced today that its Board of Directors has declared a 1-for-25 reverse stock split of the Company's issued and outstanding shares of common stock. The purpose of the reverse stock split is to bring the Company into compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market ("Nasdaq").
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.
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.
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.
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.
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.
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).