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 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.
Valion Bio (Nasdaq: VBIO) announced that subsidiary Velocity Bioworks secured an exclusive commercial development and license agreement for LarmorBio's BioScan-NMR™ platform, a next-generation NMR system.
The first commercial installation is targeted for July 2026 in San Antonio, positioning Velocity Bioworks as a reference site for advanced NMR-based diagnostics.
Valion Bio (Nasdaq: VBIO) reported first quarter 2026 results and business updates, its first full quarter under the new identity and with Velocity Bioworks integrated.
Operating expenses were $5.6M and net loss was $6.2M, with $7.2M in cash. Entolimod and Entolasta development, U.S. government engagement, and Velocity Bioworks CDMO integration advanced.
Valion Bio (Nasdaq: VBIO), a clinical-stage immunotherapeutics company developing Entolimod for Acute Radiation Syndrome and oncology supportive care, will report Q1 2026 financial results after market close on May 14, 2026.
Management will host a conference call and webcast, with a replay available on the investor website.
Valion Bio (NASDAQ: VBIO) opened Velocity Bioworks, a wholly-owned biomanufacturing facility in San Antonio on May 6, 2026, enabling end-to-end domestic production of Entolimod.
The site employs ~45 scientists and completed tech transfer with incremental scale-up to support GMP manufacturing, positioning Velocity Bioworks to serve Valion's pipeline, national preparedness, and third-party CDMO work.