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) 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.
Vitality Biopharma (VBIO) announced a $5 million equity line financing with an institutional investor.
This financing will allow the company to sell shares up to $250,000 per purchase notice until December 31, 2022, at 85% of the stock's lowest daily volume weighted average price over the prior five days.
The funds are earmarked for advancing the prodrug candidate VBX-100, which recently received Orphan Drug Designation from the FDA for pediatric ulcerative colitis.
On August 10, 2021, Vitality Biopharma (OTC: VBIO) received Orphan Drug Designation from the FDA for its glycosylated cannabinoid prodrug VBX-100, aimed at treating pediatric ulcerative colitis. This milestone highlights the company's commitment to developing innovative treatments for gastrointestinal disorders. With a portfolio of over 100 cannabinoid compounds, Vitality plans to expedite research and capitalize on the benefits of orphan designation, including seven years of market exclusivity and tax incentives for clinical trials.