Valion Bio, Inc.

Oct 14, 2026

▼ -6.5%on this news· ran to -21% by day 1

With Section 232 Tariffs Reshaping Biotech, Valion Bio's Velocity Bioworks Capitalizes on Domestic CDMO Surge

Valion Bio, Inc. emphasizes the capabilities of its CDMO, Velocity Bioworks, which supports U.S.-based manufacturing for early-phase biologics. This initiative aligns with the new Section 232 pharmaceutical tariff framework aimed at enhancing domestic production. Velocity Bioworks provides essential services for biotechnology companies, including process development and GMP drug substance manufacturing.

Oct 9, 2026

Valion Bio (Nasdaq:VBIO): Oral Mucosal Entolimod Could Offer a New Needle-Free Deployment Path to Support Growing Need for Scalable Civilian Radiation Preparedness Should Nuclear Infrastructure Expand to Support Data Centers

Valion Bio is advancing an oral mucosal formulation of Entolimod, aimed at providing a needle-free option for treating acute radiation syndrome. This development aligns with the increasing demand for scalable medical countermeasures as nuclear power expands to meet electricity needs. The formulation is being developed in collaboration with Shear Kershman Laboratories and has received FDA designations for expedited development.

Oct 5, 2026

New Valion Bio Board Chair Thomas Jensen Brings Biotech Turnaround Experience to the Advancement of Entolimod

Valion Bio's new Board Chair, Thomas H. Jensen, emphasizes the company's strong foundation and potential for success with its lead candidate, Entolimod, aimed at treating acute radiation syndrome. Jensen's experience in biotech turnaround strategies is expected to guide Valion's strategic priorities and resource allocation. The company benefits from significant government funding and FDA designations, enhancing its prospects.

Sep 30, 2026

Valion Bio and Shear Kershman Laboratories Successfully Formulate Oral Mucosal Entolimod; Valion Sees Potential for Multi-Fold Expansion of Long-Term Opportunity

Valion Bio and Shear Kershman Laboratories have successfully formulated an oral mucosal version of Entolimod, a biologic aimed at protecting cells from radiation damage. This new formulation could provide a needle-free alternative to injections, potentially expanding its use in emergencies. Future studies will assess the formulation's effectiveness in delivering Entolimod into the bloodstream.

Sep 23, 2026

▲ +9.6%on this news· ran to +40% by day 1

Valion Appoints Life Sciences Veteran Dean Zikria as Interim CEO and Announces Board Leadership Transitions

Valion Bio, Inc. has appointed Dean Zikria as Interim CEO, aiming to enhance leadership and execution as the company advances its lead candidate, Entolimod. Zikria's extensive background in biopharmaceuticals is expected to drive strategic priorities and partnerships. The company also announced changes in its Board leadership to support these goals.

Sep 22, 2026

Valion Bio Regains Compliance with NASDAQ Minimum Bid Price Listing Rule

Valion Bio, Inc. has regained compliance with Nasdaq's minimum bid price requirement, confirming a closing bid price of at least $1.00 per share. This compliance is seen as a significant step in executing the company's growth strategy, particularly in advancing its lead candidate, Entolimod, which is being developed for Acute Radiation Syndrome. The company is also pursuing additional therapeutic applications and enhancing its manufacturing capabilities.

Valion Bio Announces Changes to Management and Board of Directors

Valion Bio has announced significant changes to its management, appointing Lisa Wolf as President and COO while retaining her role as CFO. The company also welcomed new directors Jared Malbin and Thomas Jensen to its Board. These changes aim to enhance operational leadership and capitalize on market opportunities for its lead product candidate, Entolimod.

Jul 20, 2026

▼ -13%on this news· ran to -31% by day 3

World-Premier Cancer Center Sheba Medical Center Selects Entolimod for Clinical Trial, Potentially Expanding Valion Bio into the Multi-Billion-Dollar Neutropenia Market

Sheba Medical Center has selected Valion Bio's Entolimod for a clinical trial in cancer patients, marking a significant expansion into the neutropenia market. This trial aims to evaluate Entolimod's effectiveness in reducing radiation-induced neutropenia and protecting healthy tissue during radiation therapy. The study is funded by Sheba, allowing Valion to generate data with minimal investment.

Valion Bio Advances Integrated Biodefense and Immunology Platform Through Continued Government Engagement, Domestic Manufacturing and Oncology Expansion

Valion Bio is enhancing its Entolimod platform through strategic initiatives, including government engagement for Acute Radiation Syndrome preparedness and a significant manufacturing scale-up. The company is also expanding into oncology supportive care, demonstrating its evolution into an integrated biotechnology platform. These efforts aim to create multiple avenues for value creation and strengthen its market position.

AFRRI/NIAID Designs Proprietary PBI-BM2.5 Protocol to Evaluate Valion Bio's (NASDAQ: VBIO) Entolimod as the First and Only Treatment for GI-ARS

Valion Bio, Inc. announced the completion of a protocol design by AFRRI and NIAID to evaluate Entolimod for treating Gastrointestinal Acute Radiation Syndrome (GI-ARS). This development is significant as no FDA-approved treatments currently exist for GI-ARS, representing a critical market opportunity. The protocol aims to generate data necessary for future FDA licensure under the Animal Rule.

Valion Bio (NASDAQ: VBIO) Confirms U.S. House Armed Services Committee Initiative to Address Urgent Need for Radiation /Nuclear Countermeasures

Valion Bio confirmed that the U.S. House Armed Services Committee's FY27 NDAA report emphasizes the need for radiation and nuclear countermeasures. The report directs the development of plans for both prophylactic and therapeutic measures. Valion's lead candidate, Entolimod, has shown promise in treating acute radiation syndrome and has received FDA designations. CEO Michael Handley expressed optimism about the prioritization of such countermeasures.

VALION BIO BRIEFS SENIOR DEPARTMENT OF WAR AND BARDA OFFICIALS IN JOINT ENGAGEMENT ON ENTOLIMOD FOR ACUTE RADIATION SYNDROME

Valion Bio presented its lead candidate, Entolimod, for acute radiation syndrome to senior officials from the U.S. Department of War and BARDA. This engagement reflects growing government interest in Entolimod as a medical countermeasure. The focus on an oral formulation highlights its potential advantages for mass-casualty scenarios. The company aims to advance Entolimod towards a Biologics License Application under the FDA's Animal Rule.

Valion Bio Appoints Melinda Lackey Seasoned Biopharmaceutical Attorney with Deep IP, Clinical-Stage, and Nasdaq Public Company Experience Joins Leadership Team

Valion Bio has appointed Melinda Lackey as General Counsel and Senior Vice President of Legal Affairs. Lackey brings nearly two decades of experience in biopharmaceutical law, particularly in clinical-stage development and intellectual property. This appointment comes as Valion advances its drug candidate, Entolimod, towards FDA regulatory pathways while also expanding its CDMO subsidiary, Velocity Bioworks. Her legal expertise is expected to be pivotal in navigating the company's growth and regulatory challenges ahead.

Mar 4, 2026

Michael K. Handley Named CEO of Tivic Health Systems to Spearhead Strategic Expansion in Biopharma

Tivic Health Systems has appointed Michael K. Handley as its new CEO, succeeding Jennifer Ernst. Handley, an experienced leader with a strong background in life sciences, will guide the company as it focuses on late-stage immunotherapies and expands its presence in the biopharma sector. His previous successes in regulatory navigation and product commercialization position him well for this role. Ernst will continue to support Tivic during this transition, underscoring a commitment to ongoing innovation and growth.

Jan 20, 2026

Nasdaq: TIVC | www.tivichealth.com ir@tivichealth.com - January 2026 - Jennifer Ernst, CEO, Tivic Health Harnessing the immune system to save lives and improve clinical outcomes Late - stage, highly de - risked assets Co

Tivic Health, led by CEO Jennifer Ernst, is advancing its TLR5 agonist portfolio, particularly the drug Entolimod designed to counteract radiation effects. With a focus on near-term clinical milestones, the company aims to capitalize on high-value opportunities in oncology. The company has already secured significant funding and has an experienced management team in place. The ongoing development and commercialization of its late-stage assets position Tivic as a key player in the market for treating radiation damage and related conditions.

Dec 11, 2025

Tivic Acquires Ready-to-Scale cGMP

Tivic Health Systems, Inc. has acquired the manufacturing assets of Scorpius Holdings, Inc. to enhance its capacity for producing its lead drug candidate, Entolimod. As part of this move, Tivic is launching Velocity Bioworks, a new subsidiary focused on contract development and manufacturing services. This strategic acquisition, supported by a financing package totaling over $90 million, positions the company to expedite its commercialization efforts and expand development initiatives for various therapeutic applications, particularly in oncology. The transaction aligns with Tivic's mission to lower development costs and reduce lead times typically associated with outsourced manufacturing.

Nov 13, 2025

Tivic Health Reports Findings of Clinical Optimization Trial of Non-Invasive Cervical Vagus Nerve Stimulation (ncVNS)

Tivic Health Systems has reported positive results from its Clinical Optimization Trial on non-invasive cervical vagus nerve stimulation (ncVNS), revealing that personalized stimulation parameters can enhance autonomic effects. The study, conducted in collaboration with The Feinstein Institutes for Medical Research, highlights the importance of various stimulation parameters to achieve consistent outcomes. Despite encouraging findings, the study was conducted with healthy subjects, and further validation in clinical settings is necessary. The company believes these advancements could unlock new opportunities in treating larger patient populations.

Aug 20, 2025

VBIOFDA Updates

Tivic Receives Two Investigational New Drug Applications for Entolimod for the Treatment of Acute Radiation Syndrome (ARS) and Advanced Cancers INDs Transferred from Statera Biopharma Advance Entolimod for ARS Along Regu

Tivic Health Systems has received two investigational new drug applications (INDs) for its lead candidate, Entolimod. These INDs are aimed at treating acute radiation syndrome (ARS) and advanced cancers, allowing Tivic to engage the FDA for regulatory clarity and pursue clinical trials for related conditions. Entolimod acts as a TLR5 agonist and has shown promising results in animal models for survival and recovery from radiation effects. The recent developments underscore Tivic's strategic importance in addressing acute medical needs.

Aug 14, 2025

Tivic Reports Second Quarter 2025 Financial Results Company advances its TLR5 agonist program and prepares to report VNS clinical data

Tivic Health Systems, Inc. announced its financial results for Q2 2025, showing advancements in its TLR5 agonist program, with plans to exit the ClearUP business. The company has secured financing to support its strategic transformation and is preparing for FDA applications. However, the revenue decreased in comparison to the previous year due to lower consumer health product sales, and the company reported increased operating expenses and net losses. Positive developments include heightened interest in its drug candidate Entolimod for military use and promising data from its bioelectronic device trials.

Jun 25, 2025