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Valion Bio's Entolimod Regulatory Dossier Accepted by Ukraine's Ministry of Health

Valion Bio announced that Ukraine's Ministry of Health has accepted the Company's regulatory dossier for Entolimod for formal review under the country's Regulatory Equivalence Pathway. Entolimod is Valion Bio's investigational medical countermeasure for acute radiation syndrome. The dossier was accepted on July 22, 2026. The Ministry has since begun technical assessment of the dossier and issued its first round of questions, relating to the physicochemical characterization of the drug product that would be supplied under a potential stockpiling arrangement, which the Company is preparing to address. Valion Bio has since identified the documentation, analytical-testing, quality-control, manufacturing, import, and labeling requirements needed to advance the review. The Company believes a regulatory decision could occur as early as the fourth quarter of 2026, although timing and outcome remain subject to the Ministry's review, any additional information requests, and operational circumstances.

Valion Bio Launches Entolimod Study for Radiation Injury

Valion Bio announced that the Armed Forces Radiobiology Research Institute, under its contract with the National Institute of Allergy and Infectious Diseases, is conducting a U.S. Department of War government-funded program evaluating Entolimod for radiation-induced gastrointestinal injury. The program is expected to advance through a safety study and, upon its successful completion, a therapeutic study in rapid sequence. The safety study is planned to start this week. The therapeutic study will evaluate whether Entolimod, administered after radiation exposure, can support survival and GI tissue recovery following lethal doses of ionizing radiation. Top-line therapeutic data are anticipated in early fall. Radiation-induced GI injury is a major potential cause of mortality following high-dose radiation exposure and remains a key focus of U.S. medical-countermeasure development. Successful development could support Entolimod's potential role in government preparedness for radiological and nuclear mass-casualty scenarios. The therapeutic study uses a shielded-mouse model designed to preserve the majority of the animals' bone marrow. This should allow investigators to evaluate survival and tissue-recovery effects attributable specifically to GI protection, rather than confounding results with bone-marrow outcomes. The Company believes Entolimod's ability to support survival while promoting GI recovery in this model would represent a result not previously demonstrated by a U.S. government-tested countermeasure.

Valion Bio's Entolimod Accepted for Review by Ukraine's Ministry of Health

Valion Bio announced that Ukraine's Ministry of Health, or MoH, has accepted the Company's regulatory dossier for Entolimod for formal review under Ukraine's Regulatory Equivalence Pathway, following the Ministry's earlier request that the Company submit the application. Following the Ministry's request for submission, Ukraine's Ministry of Health has accepted Valion Bio's Entolimod regulatory dossier for formal review under its Regulatory Equivalence Pathway. The acceptance initiates the Ministry's scientific and regulatory evaluation and represents the first allied-nation regulatory review of Entolimod. Building on the Company's March 31 announcement of the Ministry's request, the engagement reflects an allied nation moving to secure access to a medical countermeasure for radiological preparedness. The Company is positioned to support that demand. Ukraine operates a facilitated "recognition" registration pathway for biological products that is based on the regulatory reviews of select foreign authorities, including the FDA. Accordingly, the Company anticipates that the MoH review may rely on the FDA's current review status and documentation for Entolimod, which the Company believes could allow the technical review to be completed in as little as 45 days - with actual timing dependent on the Ministry's questions and its operational circumstances.