Welcome to our dedicated page for Valion Bio news (Ticker: VBIO), a resource for investors and traders seeking the latest updates and insights on Valion Bio stock.
Valion Bio, Inc. reports company developments tied to its TLR5 agonist immunotherapeutic pipeline, including Entolimod™ for Acute Radiation Syndrome and oncology supportive care and Entolasta™ as a next-generation TLR5 agonist. Recurring updates include financial results, business updates, FDA pathway and designation references, government and biodefense engagement, and clinical-development positioning for supportive-care indications.
Valion Bio news also covers its completed rebranding from Tivic Health Systems, the Nasdaq ticker change to VBIO, leadership and legal-governance appointments, and activity at Velocity Bioworks, the company's wholly owned CDMO subsidiary in San Antonio.
Valion Bio (NASDAQ:VBIO) announced management and board changes intended to support its next growth phase. The board unanimously appointed current CFO Lisa Wolf as President and Chief Operating Officer, effective immediately. She will retain the CFO role and assume executive leadership following the departure of former CEO Michael K. Handley.
According to Valion, Wolf will oversee advancement of lead candidate Entolimod and efforts to expand government, international and commercial partnerships. The company also appointed Thomas Jensen and Jared Malbin to its board, adding biotechnology, oncology, capital markets and regulatory expertise. Entolimod has FDA Fast Track and Orphan Drug designations for Acute Radiation Syndrome.
Valion Bio (Nasdaq: VBIO) announced a 1-for-25 reverse stock split of its issued and outstanding common shares, effective August 31, 2026, at 12:01 a.m. Eastern Time. VBIO is expected to begin trading on a split-adjusted basis that same day under its existing ticker, with a new CUSIP of 918942202.
The split, approved by stockholders on August 14, 2026, is intended to help Valion Bio regain compliance with Nasdaq’s minimum $1.00 bid price requirement before the current September 15, 2026 deadline. All 25 pre-split shares will be reclassified into one share, with proportional adjustments to preferred stock conversion terms, equity awards, options, warrants and equity plan reserves. No fractional shares will be issued; any fraction will be rounded up to the nearest whole share. The number of authorized shares, par value, and outstanding preferred stock will remain unchanged, and Odyssey Transfer and Trust Company will act as exchange agent.
Valion Bio (Nasdaq: VBIO) announced that Ukraine's Ministry of Health accepted the regulatory dossier for its investigational ARS countermeasure Entolimod for formal review on July 22, 2026 under the country's Regulatory Equivalence Pathway and has begun a technical assessment.
The Ministry has issued initial questions on physicochemical characterization for a potential stockpiling arrangement, and Valion Bio has identified required analytical-testing, quality-control validation, GMP verification, import documentation, and Ukrainian-language labeling steps. According to the company, a regulatory decision could occur as early as Q4 2026, though timing and outcome are uncertain. A favorable decision would represent Entolimod's first national registration and could open a pathway toward possible inclusion in Ukraine's strategic reserves and future government procurement, but no procurement or stockpiling agreements have been executed and registration alone would not generate revenue.
Valion Bio (Nasdaq:VBIO) announced that the Armed Forces Radiobiology Research Institute (AFRRI), under a National Institute of Allergy and Infectious Diseases (NIAID) contract and funded by the U.S. Department of War, is running a government-funded program evaluating Entolimod for lethal radiation-induced gastrointestinal (GI) injury.
Entolimod has been delivered to AFRRI, IACUC approval is in place, animals are acclimating, and a safety study is planned to start this week. Upon successful completion, a therapeutic study will begin to test post-exposure administration on survival and GI tissue recovery using a shielded-mouse model, with top-line therapeutic data anticipated in early fall. A potential prophylactic study is under consideration but not yet confirmed. According to Valion Bio, Entolimod has extensive animal and human safety data, was developed under the FDA Animal Rule, holds Fast Track and Orphan Drug designations, and could, if successful, be relevant for U.S. radiological and nuclear preparedness.
Valion Bio (Nasdaq: VBIO) announced that Ukraine's Ministry of Health has accepted its Entolimod regulatory dossier for formal review under Ukraine's Regulatory Equivalence Pathway, initiating scientific and regulatory evaluation of this medical countermeasure for Acute Radiation Syndrome.
The facilitated FDA-recognition pathway may allow a regulatory decision in as few as 45–60 days, depending on Ministry questions and operations. This is the first known allied-nation review of Entolimod. Valion Bio's wholly owned CDMO, Velocity Bioworks, has demonstrated manufacturing capacity equivalent to about 1.3 million doses, positioning the company to potentially support national stockpile and allied-government requirements.
Valion Bio (Nasdaq: VBIO) announced that Sheba Medical Center, ranked the world’s #7 hospital, has finalized a clinical trial protocol to evaluate Entolimod in cancer patients receiving high-dose radiation for a rare cancer. Sheba independently selected Entolimod for its potential to reduce radiation-induced neutropenia and protect healthy tissue.
The Sheba study, enrolling up to 10 adults, is planned to be fully funded and conducted by Sheba, while Valion Bio supplies Entolimod and limited non-standard-of-care support. According to Valion Bio, this creates a second clinical development pathway beyond its FDA Animal Rule program for Acute Radiation Syndrome, potentially expanding Entolimod into the larger supportive oncology and neutropenia markets. Key expected milestones include IRB approval in Q3 2026, first patient enrollment in Q4 2026–Q1 2027, an interim readout in early 2027, and topline data in 2027.
Valion Bio (Nasdaq: VBIO) outlined recent progress on its Entolimod platform, including continued engagement with BARDA, NIAID, AFRRI, the U.S. Department of War and Ukraine’s Ministry of Health on potential Acute Radiation Syndrome (ARS) preparedness, development support and Strategic National Stockpile or national reserve opportunities. No funding, procurement or stockpiling agreements have been executed.
The company demonstrated an approximately 200-fold manufacturing scale-up of Entolimod via its wholly owned CDMO, Velocity Bioworks, at 50-liter scale, estimating about 1.3 million potential human doses while meeting purity and potency specifications. Valion Bio is preparing physician-sponsored oncology supportive care studies in neutropenia and advancing Entolasta, a next-generation TLR5 agonist, to extend its platform beyond biodefense. According to Valion Bio, over $140 million has been invested historically in Entolimod development, providing a foundation for its integrated strategy spanning government preparedness, domestic biomanufacturing and oncology expansion, though all programs remain subject to regulatory, funding and execution risks.
Valion Bio (NASDAQ:VBIO) announced that AFRRI, in partnership with NIAID, has finalized a proprietary PBI-BM2.5 survival efficacy protocol to evaluate Entolimod for treating gastrointestinal acute radiation syndrome (GI-ARS).
The murine model meets FDA Animal Rule criteria. No FDA-approved GI-ARS countermeasures currently exist. The ARS market is estimated at $5.47B in 2025, growing to $7.80B by 2032.
Valion Bio (NASDAQ: VBIO), a late-stage biopharma company, highlighted a U.S. House Armed Services Committee FY27 NDAA report directive for a resources and fielding plan prioritizing radiation/nuclear countermeasures that are both prophylactic and therapeutic.
This aligns with Valion Bio's lead candidate, Entolimod, which has shown survival benefit as a radioprotectant and radiomitigant in non-human primate studies under the FDA Animal Rule.
Valion Bio (Nasdaq: VBIO) briefed senior U.S. Department of War and BARDA officials on Entolimod for acute radiation syndrome on May 14, 2026.
Discussion highlighted interest in an oral formulation, dual-tissue radioprotection, prior $35.6M in U.S. government funding, extensive nonclinical and clinical evaluation, and FDA Fast Track, Orphan Drug, and Animal Rule development pathway.