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) 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.
Valion Bio (Nasdaq: VBIO) received an FDA‑precedent study protocol from NIAID for Entolimod™, triggering NIAID to fully fund up to $7 million of BLA‑enabling in vivo studies and to co‑navigate the FDA Animal Rule submission if studies are favorable.
Studies will run at AFRRI; protocol matches a prior FDA‑accepted design, which the company says reduces regulatory design risk. Entolimod has prior nonhuman primate and human exposure data, plus Fast Track and Orphan Drug designations for ARS.
Valion Bio (Nasdaq: VBIO) appointed Melinda Lackey as General Counsel and Senior Vice President of Legal Affairs, effective May 4, 2026. Ms. Lackey brings nearly two decades of combined scientific, IP, clinical-stage, and Nasdaq public company experience.
Her background includes senior legal roles at Alaunos Therapeutics and Kuur Therapeutics, patent litigation experience at Winston & Strawn and Howrey, and early research roles at UT Health Science Center and MD Anderson. The hire is positioned to support Entolimod's FDA Animal Rule pathway, an ongoing capital raise, and scaling of the Velocity Bioworks CDMO in San Antonio.
Valion Bio (NASDAQ: VBIO) briefed senior Pentagon leadership on Entolimod, a TLR5 agonist being developed as a next-generation medical countermeasure for acute radiation syndrome (ARS).
The program has >$140M invested, including ~$35.6M in non-dilutive U.S. government funding, 42 non-human primate studies, ~300 human subjects, FDA Fast Track and Orphan Drug designations, and is being advanced toward a Biologics License Application under the Animal Rule.
Valion Bio (formerly Tivic Health Systems; Nasdaq: TIVC → VBIO) completed a strategic transformation into a late-stage biopharmaceutical company, effective April 28, 2026. The company centers on lead candidate Entolimod, a TLR5 agonist with FDA Fast Track and Orphan Drug designations and Animal Rule development for ARS.
Valion also owns CDMO Velocity Bioworks (acquired Dec 2025 for ~$16.3M), completed a 200-fold Entolimod scale-up at 50L, and is engaging BARDA and other agencies on SNS procurement that could represent a non-dilutive, potentially nine-figure revenue event.
Vitality Biopharma, Inc. (OTC Mkts: VBIO) announced the effectiveness of its Form S-1 registration statement by the SEC, enabling an equity line financing of up to $5 million with Triton Funds. The funds will primarily support the advancement of VBX-100, a cannabinoid prodrug recently granted Orphan Drug Designation by the FDA for pediatric ulcerative colitis. Additionally, the company's common shares are now DTC eligible, enhancing their market efficiency and reducing transaction costs.