Valion Bio, Inc. operates as a late-stage biopharmaceutical company. Its lead drug candidate is Entolimod, a TLR5 agonist that is in late-stage development to treat acute radiation syndrome. The company's pipeline also comprises Entolimod to treat Neutropenia and lymphocyte exhaustion; and Entolasta, an immunologically optimized variant of Entolimod for chronic applications, such as immunosenescence. In addition, it offers CDMO services. The company was formerly known as Tivic Health Systems, Inc. and changed its name to Valion Bio, Inc. in April 2026. The company was incorporated in 2016 and is based in San Antonio, Texas.
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.