Valion Bio, Inc.

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

2026-08-12 09:29:00

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

2026-07-22 07:45:00

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

2026-07-20 13:28:00

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

2026-07-14 07:45:00

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

2026-06-25 07:45:00

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

2026-06-11 08:00:00

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

2026-06-11 07:45:00

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

2026-05-19 16:38:00

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.