Valion Bio, Inc.

Valion Bio Advancing Entolimod into U.S. Government-Funded Therapeutic Efficacy Study Following Positive Safety Results

Valion Bio is advancing Entolimod into a U.S. government-funded therapeutic efficacy study at AFRRI, testing whether post-exposure treatment improves survival in a gastrointestinal acute radiation syndrome model. The study is fully funded by NIAID's Radiation and Nuclear Countermeasures Program, preserving Valion's capital while generating efficacy data; dosing occurs 24 hours after radiation exposure with 30-day survival monitoring. Top-line results are anticipated in early December, and a survival benefit would mark a clinically significant milestone for Entolimod under the FDA Animal Rule pathway.

•2d ago

Valion Bio Announces Positive Safety Results From U.S. Government-Funded Entolimod Study, Paving Way For Therapeutic Efficacy Evaluation

Valion Bio announced final results from a government-funded safety study of its lead candidate Entolimod, a TLR5 agonist being developed as a medical countermeasure for acute radiation syndrome. The AFRRI-conducted study in 20 mice showed no statistically significant differences versus saline control in body weight, blood counts, or serum chemistry, with no treatment-related toxicity observed over 14 days. With the safety phase complete, a fully funded AFRRI therapeutic study is planned to test whether Entolimod improves survival and GI tissue recovery after radiation exposure — the key efficacy readout for the program.

•4d ago

Valion Bio Receives Unsolicited Acquisition Interest in Velocity Bioworks; Weighs Strategic Options

Valion Bio has received unsolicited acquisition inquiries from independent third parties for Velocity Bioworks, its wholly owned biologics CDMO subsidiary, and has entered preliminary discussions while weighing a range of strategic options including a possible sale. The Board has retained a nationally recognized investment banking firm as financial advisor, with any deal's key priority being retention of production rights and manufacturing capabilities for lead candidate Entolimod. A sale could fund Entolimod's development, which is being advanced under the FDA Animal Rule as a medical countermeasure for Acute Radiation Syndrome with Fast Track and Orphan Drug designations. Discussions remain preliminary and there is no assurance of a definitive agreement.

•6d ago

Valion Bio's New Leadership Unveils 30-Day Agenda to Accelerate Clinical Pipeline and Unlock Shareholder Value

Valion Bio's new interim CEO Dean Zikria laid out a 30-day strategic agenda focused on advancing Entolimod, monetizing the Velocity Bioworks CDMO, and disciplined capital allocation. The company has begun evaluating strategic options for Velocity, including partnerships, co-investment, licensing, or an outright sale, though no transaction is committed and no timeline was given. Entolimod, the lead ARS drug candidate, has received roughly $35.6 million in non-dilutive U.S. government funding and holds FDA Fast Track and Orphan Drug designations, with new development pathways underway including an oral mucosal formulation and a GI-injury program with AFRRI.

•11d ago

Valion Bio's Next-Generation NMR Partnership with LarmorBio Delivers Initial Feasibility Milestone

Valion Bio's CDMO subsidiary Velocity Bioworks completed an initial feasibility evaluation of partner LarmorBio's BioScan-NMR platform for biologics manufacturing monitoring. The test showed NMR signals strongly correlated with OD600 cell-density measurements, suggesting potential to track microbial fermentation growth in real time without invasive sampling. Management framed the milestone as early proof-of-concept, with next steps focused on closed-system and continuous monitoring assessment; no financial terms were disclosed.

•17d ago

Valion Bio (Nasdaq:VBIO): Oral Mucosal Entolimod Could Offer a New Needle-Free Deployment Path to Support Growing Need for Scalable Civilian Radiation Preparedness Should Nuclear Infrastructure Expand to Support Data Centers

Valion Bio completed formulation work with Shear Kershman Laboratories on a needle-free oral mucosal version of Entolimod using SKL's BioViscid™ delivery platform. Entolimod, the company's lead TLR5 agonist candidate for Acute Radiation Syndrome, is being positioned as a scalable radiation countermeasure amid nuclear-power expansion driven by AI data-center electricity demand. The release cites animal and non-human-primate data showing pre- and post-exposure protection and notes no FDA-approved treatment exists for the gastrointestinal component of ARS; it remains early-stage with no clinical or financial results disclosed.

•23d ago

Valion Bio and Shear Kershman Laboratories Successfully Formulate Oral Mucosal Entolimod; Valion Sees Potential for Multi-Fold Expansion of Long-Term Opportunity

Valion Bio and Shear Kershman Laboratories completed formulation work on an oral mucosal version of Entolimod using SKL's BioViscid drug-delivery platform. If systemic delivery and regulatory authorization are ultimately achieved, Valion estimates potential U.S. dose requirements of roughly 10 to 40 times its injectable program, covering military, firefighter, and law-enforcement populations. The next key milestone is demonstrating measurable systemic exposure; the addressable-opportunity estimate is explicitly not a revenue forecast, and realization depends on product performance, regulatory decisions, and procurement funding.

•1mo ago

Valion Bio Regains Compliance with NASDAQ Minimum Bid Price Listing Rule

Valion Bio (Nasdaq: VBIO) received formal written notification from Nasdaq confirming it has regained compliance with the minimum bid price requirement under Listing Rule 5550(a)(2), and the matter is now closed. The company satisfied the rule by maintaining a closing bid of at least $1.00 per share for the requisite period, eliminating the delisting overhang on its Nasdaq Capital Market listing. President, COO and CFO Lisa Wolf framed the restoration as an important step in executing the growth strategy, with the pipeline centered on Entolimod, a TLR5 agonist developed under the FDA Animal Rule as a potential medical countermeasure for Acute Radiation Syndrome, alongside the next-generation TLR5 agonist Entolasta.

•1mo ago

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

Ukraine's Ministry of Health accepted the Entolimod dossier for formal review on July 22, 2026, initiating the technical assessment phase under the Regulatory Equivalence Pathway. Valion Bio believes a regulatory decision could occur as early as the fourth quarter of 2026, which would mark Entolimod's first national registration and open a pathway to potential government stockpiling. Management emphasized that while registration is a critical milestone, no procurement or stockpiling agreement has been executed and registration alone would not generate revenue.

•2mo ago

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

Valion Bio announced that AFRRI, under contract with NIAID, is initiating two government-funded studies of Entolimod for lethal radiation-induced GI injury, with the safety study starting this week. The therapeutic study is designed to evaluate survival and tissue recovery in a shielded-mouse model, with top-line data anticipated in early fall. Management highlighted that if successful, Entolimod would be the first drug to provide both hematopoietic and GI protection in this context.

•2mo ago

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

Ukraine's Ministry of Health has accepted Valion Bio's regulatory dossier for Entolimod for formal review under the country's Regulatory Equivalence Pathway. This review represents the first formal evaluation of Entolimod by an allied nation and leverages prior U.S. regulatory work, with a potential decision expected within 45 to 60 days. Valion Bio noted that its subsidiary, Velocity Bioworks, has scaled manufacturing to support the production of approximately 1.3 million doses, positioning the company to meet potential government stockpile requirements.

•3mo ago

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, ranked the #7 hospital in the world, selected Valion Bio's Entolimod for a clinical trial to evaluate its ability to reduce radiation-induced neutropenia in cancer patients. The study will enroll up to 10 patients and is fully funded by Sheba, marking a capital-efficient expansion of Entolimod's development beyond Acute Radiation Syndrome into supportive oncology. CEO Michael K. Handley highlighted the collaboration as external validation of the company's science and a potential entry into a significantly larger commercial market.

•3mo ago

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

Valion Bio achieved a 200-fold manufacturing scale-up of its Entolimod candidate through subsidiary Velocity Bioworks, reaching a 50-liter fermentation scale equivalent to approximately 1.3 million potential human doses. The company is actively engaging with U.S. agencies BARDA, NIAID and the DoW, as well as Ukraine's Ministry of Health regarding potential procurement, though no funding or agreements have been executed yet. Valion is also expanding its TLR5 platform into oncology supportive care, planning physician-sponsored studies for neutropenia while advancing its next-generation agonist Entolasta.

•3mo ago

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

The Armed Forces Radiobiology Research Institute (AFRRI) and NIAID have finalized the design of the PBI-BM2.5 protocol to evaluate Valion Bio's Entolimod for GI-ARS, meeting FDA Animal Rule criteria. This proprietary murine model isolates GI pathophysiology to generate the high-quality non-clinical efficacy data required for potential licensure under the FDA's Animal Rule. Valion Bio targets a significant unmet need in a market projected to grow from $5.47 billion to $7.80 billion by 2032, with North America accounting for 46% of revenue.

•4mo ago

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

Valion Bio confirmed that the U.S. House Armed Services Committee’s FY27 NDAA report directs the Department of Defense to develop a plan for prioritizing radiation and nuclear countermeasures that are both prophylactic and therapeutic. This policy directive aligns with Valion Bio’s lead candidate, Entolimod, which has demonstrated efficacy as both a radioprotectant and radiomitigant in non-human primate studies under the FDA’s Animal Rule. The company recently briefed senior Pentagon and BARDA officials on Entolimod, though the NDAA report does not explicitly name Valion Bio or guarantee any funding or contract awards.

•4mo ago

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

Valion Bio’s subsidiary Velocity Bioworks secured an exclusive commercial license to LarmorBio’s BioScan-NMR platform, a next-generation NMR system for rapid cell phenotyping. The deal includes a strategic reference site arrangement, with the first commercial installation targeted for July 2026 at Valion’s San Antonio facility. Valion acquired these rights at pre-institutional pricing ahead of LarmorBio’s pending Series A, positioning Velocity Bioworks as a co-dependent strategic partner rather than a conventional customer.

•5mo ago

Valion Bio Celebrates Grand Opening of Velocity Bioworks Biomanufacturing Facility in San Antonio, Anchoring Domestic Production of Entolimod™

Valion Bio celebrated the grand opening of its wholly-owned subsidiary Velocity Bioworks in San Antonio, marking the activation of its domestic manufacturing capabilities for lead asset Entolimod. The facility employs approximately 45 staff and positions the company to secure U.S. government contracts for radiation countermeasures by controlling its end-to-end supply chain. Management highlighted the strategic importance of vertical integration, noting that domestic production is critical for earning government trust and supporting future oncology supportive care initiatives.

•5mo ago

VALION BIO RECEIVES FIRST FDA-PRECEDENT STUDY PROTOCOL FROM NIAID FOR ENTOLIMOD™; FEDERAL AGENCY TO FULLY FUND BLA-ENABLING IN VIVO PROGRAM AND CO-NAVIGATE FDA SUBMISSION

Valion Bio received an FDA-precedent study protocol from NIAID under an agreement valued at up to $7 million, with the agency fully funding BLA-enabling studies and co-navigating the FDA submission. The partnership significantly de-risks the Animal Rule pathway for Entolimod, allowing the company to redirect approximately $7 million in planned capital toward its second-generation asset, Entolasta. The initial study targets Partial-Body GI-ARS, a critical gap in the Strategic National Stockpile not addressed by current agents like Neupogen or Neulasta.

•5mo ago

VALION BIO BRIEFS PENTAGON LEADERSHIP ON ENTOLIMOD™ FOR ACUTE RADIATION SYNDROME

Valion Bio briefed senior leadership at the Pentagon on Entolimod, its lead TLR5 agonist candidate for acute radiation syndrome. The presentation to the Deputy Assistant Secretary of Defense highlighted the drug's dual-tissue protection mechanism, which addresses gaps in current stockpiled countermeasures like Neupogen. With over $140 million invested in the program and recent selection for the Department of War's Tech Watch program, the briefing validates the company's positioning in the biodefense sector.

•6mo ago