Valion Bio (VBIO)
Develops radiation-injury immunotherapeutics and offers biologics CDMO services.
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.
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.
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).
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
Valion Bio Inc. (VBIO) Q1 2026 Earnings Call Prepared Remarks Transcript
Valion Bio Inc. (VBIO) Q1 2026 Earnings Call Prepared Remarks Transcript
Valion Bio to Report First Quarter 2026 Financial Results on May 14, 2026
SAN ANTONIO, Texas, May 11, 2026 /PRNewswire/ -- Valion Bio, Inc. (formerly Tivic Health Systems, Inc.) (Nasdaq: VBIO), a clinical-stage immunotherapeutics company developing Entolimod™ for Acute Radiation Syndrome (ARS) and oncology supportive care, today announced that it will report financial results for the first quarter ended March 31, 2026, after market close on Thursday, May 14, 2026. Management will host a conference call and webcast to discuss the Company's financial results and provide a business update.
Valion Bio Celebrates Grand Opening of Velocity Bioworks Biomanufacturing Facility in San Antonio, Anchoring Domestic Production of Entolimod™
Senator John Cornyn recognizes facility's role in advancing radiation countermeasures for cancer patients and U.S. warfighters; Mayor Gina Ortiz Jones, Office of Senator Cornyn, and Velocity Bioworks leadership join Valion Bio at ribbon cutting ceremony SAN ANTONIO, May 6, 2026 /PRNewswire/ -- Valion Bio, Inc. (Nasdaq: VBIO), a clinical-stage immunotherapeutics company developing Entolimod™ for acute radiation syndrome, oncology supportive care, and longevity indications, today celebrated the grand opening of its wholly-owned biomanufacturing subsidiary, Velocity Bioworks, at a ribbon-cutting ceremony in San Antonio. The facility, located on the VelocityTX innovation campus on San Antonio's historic East Side, marks the formal activation of the company's vertically integrated manufacturing strategy and positions Valion Bio as one of the few clinical-stage biotechs with end-to-end domestic biomanufacturing capability for its lead asset.
Valion Bio Appoints Melinda Lackey as General Counsel
/PRNewswire/ -- Valion Bio, Inc. (formerly Tivic Health Systems, Inc.) (Nasdaq: VBIO), a clinical-stage immunotherapeutics company developing Entolimod for
Vitality Biopharma Announces Effective S-1 Registration Statement and DTC Eligibility
CLEVELAND, Sept. 02, 2021 (GLOBE NEWSWIRE) -- Vitality Biopharma, Inc. (OTC Mkts: VBIO) (“Vitality” or the “Company”), an innovation-driven drug development company dedicated to unlocking the therapeutic powers of cannabinoids, today announced that the Securities and Exchange Commission has declared the Company's Form S-1 registration statement effective. The registration statement was filed pursuant to the Securities Purchase Agreement, dated as of August 19, 2021, entered into by the Company with Triton Funds LP (“Triton”) and its affiliate, Triton Funds LLC. The registration statement registers for resale the securities to be issued to Triton under an equity line financing of up to $5,000,000. Only Triton may use the related prospectus to resell the shares registered under the registration statement.