Government acceptance initiates formal regulatory review of Entolimod under Ukraine's Regulatory Equivalency pathway, with a potential review expected in as few as 45- to 60-days.
- Ukraine Ministry of Health Accepts Entolimod for Formal Review — Following its request for submission, Ukraine's Ministry of Health has accepted Valion Bio's Entolimod regulatory dossier for formal review under the country's Regulatory Equivalence Pathway, initiating the Ministry's scientific and regulatory evaluation.
- Potential Regulatory Decision Expected in 45–60 Days — Ukraine's FDA-recognition pathway leverages existing U.S. regulatory work and may enable a regulatory decision in as few as 45 to 60 days, subject to the Ministry's review and any information requests.
- First Allied-Nation Regulatory Review of Entolimod — The review represents the first known formal regulatory evaluation of Entolimod by an allied nation, expanding the program beyond its U.S. development efforts and creating a potential pathway toward international government procurement.
- Manufacturing Capacity Supports Government Preparedness Programs — Valion Bio's wholly owned CDMO, Velocity Bioworks, has demonstrated manufacturing capacity equivalent to approximately 1.3 million doses of Entolimod, positioning the Company to support potential national stockpile and allied-government requirements.
SAN ANTONIO, July 22, 2026 /PRNewswire/ -- Valion Bio, Inc. (Nasdaq: VBIO) today announced that Ukraine's Ministry of Health (MoH) has accepted the Company's regulatory dossier for Entolimod—a medical countermeasure for Acute Radiation Syndrome (ARS)—for formal review under Ukraine's Regulatory Equivalence Pathway, following the Ministry's earlier request that the Company submit the application.
"This marks an exciting milestone for Valion Bio and, more importantly, for the patients, civilians and military personnel who could one day benefit from Entolimod," said Michael K. Handley, Chief Executive Officer of Valion Bio. "For the first time, a sovereign health ministry has not only requested our submission but has accepted Entolimod for formal regulatory review. We believe this reflects both the importance of this unmet need and growing international recognition of Entolimod's potential as a medical countermeasure against acute radiation syndrome."
Government Acceptance Initiates Formal Review
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, 2026 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. Through its wholly owned CDMO, Velocity Bioworks, Valion Bio has demonstrated a 200-fold manufacturing scale-up of Entolimod at 50-liter fermentation — a scale with the potential to produce approximately 1.3 million human doses, meeting purity and potency specifications — and is prepared to supply Entolimod at the volumes national-stockpile and allied-nation programs require.
A pathway built on Entolimod's U.S. regulatory foundation
Ukraine operates a facilitated "recognition" registration pathway for biological products that is based on the regulatory reviews of select foreign authorities, including the U.S. Food and Drug Administration ("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. Entolimod is being developed in the United States under the FDA's Animal Rule for Acute Radiation Syndrome and has received FDA Fast Track and Orphan Drug designations.
Grounded in Entolimod's U.S. development
Entolimod's development has been supported by engagements with U.S. government agencies, including BARDA, NIAID, DTRA, and the Department of War. The Ukraine submission extends that foundation toward allied-nation consideration, without diverting resources from the Company's domestic program.
"Unlike currently available therapies that primarily stimulate recovery of the bone marrow, Entolimod is designed to protect both the hematopoietic system and the gastrointestinal tract from radiation injury. We believe that dual-system protection could prove critical in higher-dose radiation events, where preserving multiple organ systems may determine survival. As geopolitical risks continue to evolve, governments are placing renewed emphasis on preparedness for radiological and nuclear emergencies. We believe Entolimod has the potential to become an important component of that preparedness—not only for the United States and its warfighters, but also for allied nations seeking to strengthen their medical countermeasure capabilities. Ukraine's decision to accept Entolimod for formal review represents an important milestone toward realizing that broader opportunity," Handley added.
About Entolimod
Entolimod represents a paradigm shift in the treatment of Acute Radiation Syndrome. Growth-factor therapies currently held in the U.S. Strategic National Stockpile — such as Neupogen® (filgrastim) and Neulasta® (pegfilgrastim), both G-CSF agents, and Leukine® (sargramostim), a GM-CSF agent — are effective at stimulating the recovery of white blood cells after depletion, but they do not address the lethal damage caused to the gastrointestinal ("GI") tract at higher radiation doses.
As a selective TLR5 agonist, Entolimod activates the NF-κB signaling pathway, through a cascade of cell signaling pathways, actively preventing programmed cell death (apoptosis) in both bone marrow and GI epithelial tissues. This dual-system protection offers a comprehensive survival benefit that currently approved G-CSF therapies cannot provide, positioning Entolimod as a unique and essential candidate for national defense and emergency response.
About Valion Bio, Inc.
Valion Bio, Inc. (Nasdaq: VBIO) is developing biologics that activate innate immune pathways for cytoprotection and modulate immune responses in conditions driven by radiation, disease, and immune dysregulation. The Company's lead candidate, Entolimod for acute radiation syndrome (ARS), has been extensively studied and has demonstrated survival benefits and improved tissue recovery in animal models under the FDA's Animal Rule, which allows the Agency to approve new drugs and biological products based on animal efficacy studies when human clinical trials are unethical or not feasible, such as in the case of internal radioactive contamination. Entolimod is a novel Toll-like receptor 5 (TLR5) agonist that activates NF-κB signaling pathways to protect cells from damage and stimulate immune responses. Entolimod for ARS has received Fast Track and Orphan Drug designations from the FDA. Valion Bio is also advancing Entolasta, a next-generation TLR5 agonist designed for potential broader therapeutic applications, including oncology supportive care. Valion Bio's wholly owned subsidiary, Velocity Bioworks, a contract development and manufacturing organization (CDMO), currently provides biomanufacturing services to Valion, and is working towards providing services to third-party biotech companies in the future. For more information, visit www.valionbio.com.
Forward-Looking Statements
This press release may contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Valion Bio, Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including as a result of the company's interactions with and guidance from the FDA and other regulatory authorities; the timing, conduct, and outcome of regulatory submissions and reviews by the Ukrainian Ministry of Health and other non-U.S. regulatory authorities; the continued interest of BARDA, the Department of War, NIAID, DTRA, and other U.S. and allied government agencies in Entolimod; the ability of the company to achieve the expected benefits from international regulatory submissions or potential procurement arrangements within expected time frames or at all; changes to the company's relationship with its partners; failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations, including related to the Animal Rule; the company's future development of Entolimod or Entolasta; changes to the company's business strategy; timing and success of pre-clinical and clinical trials and study results; regulatory requirements and pathways for approval; the company's ability to successfully commercialize its product candidates in the future; changes in the markets and industries in which the company does business; consummation of any strategic transactions; the company's need for, and ability to secure when needed, additional working capital; the company's ability to maintain its Nasdaq listing; and changes in tariffs, inflation, legal, regulatory, political and economic risks. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Valion Bio's filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 30, 2026, under the heading "Risk Factors," as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and the company undertakes no duty to update such information except as required by applicable law.
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