Virax Biolabs Partners with Emory University on ViraxImmune™ Clinical Studies; Readies for FDA Pre-Submission Meeting in Early September
Rhea-AI Summary
Virax Biolabs (NASDAQ:VRAX) has entered into a Research Services Agreement with Emory University's ADJUST Center to conduct clinical studies of ViraxImmune™, focusing on immune profiling in post-viral syndromes, particularly long COVID (PASC).
The company is preparing for a pre-submission meeting with the FDA in early September 2025 to discuss ViraxImmune™'s regulatory pathway and intended use. Emory's Laboratory for Innovative Assay Development (ELIAD) will handle patient recruitment, testing, and analysis to generate clinical data supporting regulatory submissions.
ViraxImmune™ is a T cell testing technology that evaluates patient immune response profiles, offering potential advantages over traditional antibody testing for diagnosing chronic and post-viral conditions.
Positive
- Partnership with prestigious Emory University for clinical validation
- Advancing towards FDA regulatory pathway with pre-submission meeting
- Targeting large market opportunity in long COVID diagnostics
- Proprietary T cell testing technology offering advantages over conventional antibody tests
Negative
- No clinical validation data available yet
- FDA approval timeline uncertain
- Product still in development phase with no immediate revenue
News Market Reaction
On the day this news was published, VRAX declined 18.18%, reflecting a significant negative market reaction. Argus tracked a peak move of +47.6% during that session. Argus tracked a trough of -28.3% from its starting point during tracking. Our momentum scanner triggered 20 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $747K from the company's valuation, bringing the market cap to $3M at that time. Trading volume was exceptionally heavy at 311.6x the daily average, suggesting significant selling pressure.
Data tracked by StockTitan Argus on the day of publication.
Under the agreement, the Emory Laboratory for Innovative Assay Development ("ELIAD") will conduct patient recruitment, testing, and analysis to generate clinical data. This data is intended to support Virax's planned regulatory submissions and potential future commercial rollout.
This collaboration aligns with Virax's preparations for a pre-submission meeting with the
"Partnering with Emory University, one of the foremost institutions in immunology and clinical research, is an important step toward validating ViraxImmune™ in real-world patient populations," said James Foster, Chief Executive Officer of Virax Biolabs. "With millions suffering from long COVID and other post-viral conditions without effective diagnostic options, we believe ViraxImmune™ is uniquely positioned to fill this gap. This collaboration advances our broader U.S. market entry strategy and represents a significant opportunity to create long-term value for our shareholders as we work to establish Virax as a leader in immune profiling diagnostics."
Dr. Wilbur A. Lam, MD, PhD, Professor of Pediatrics and Biomedical Engineering at Emory University and Georgia Tech, and Director of the ADJUST Center, commented: "PASC and other post-viral syndromes remain poorly understood and underdiagnosed. Immune profiling technologies could provide critical insights into patient immune function, enabling more precise diagnosis and potentially guiding treatment strategies."
ViraxImmune™ is a proprietary T cell testing technology designed to evaluate a patient's immune response profile. Unlike conventional antibody testing, it assesses T cell reactivity to provide a more comprehensive picture of immune health in chronic and post-viral conditions.
About Virax Biolabs Group Limited
Virax Biolabs Group Limited is an innovative biotechnology company focused on the detection of immune responses to and diagnosis of viral diseases. Virax Biolabs Group Limited is currently developing T cell-based test technologies with the intention of providing an immunology profiling platform. T cell testing can be particularly effective in the diagnosis and therapeutics of post-viral syndromes such as long COVID and other chronic conditions linked to immune dysregulation.
For more information, please visit www.viraxbiolabs.com.
About Emory University
Emory University is a leading research institution based in
Caution Concerning Forward Looking Statements:
This press release contains forward-looking statements. In addition, from time to time, we or our representatives may make forward-looking statements orally or in writing. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance, including: our financial performance and projections; our growth in revenue and earnings; and our business prospects and opportunities. You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as "may," "should," "expects," "anticipates," "contemplates," "estimates," "believes," "plans," "projected," "predicts," "potential," or "hopes" or the negative of these or similar terms. In evaluating these forward-looking statements, you should consider various factors, including: our ability to change the direction of the Company; our ability to keep pace with new technology and changing market needs; and the competitive environment of our business. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking events discussed in this press release and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties, and assumptions about us. These forward-looking statements are based on information currently available to Virax and its current plans or expectations and are subject to a number of known and unknown uncertainties, risks and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the "Risk Factors" section of Virax's Annual Report on Form 20-F for the year ended March 31, 2025. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. We are not obligated to publicly update or revise any forward-looking statement, whether as a result of uncertainties and assumptions, the forward-looking events discussed in this press release and other statements made from time to time by us or our representatives might not occur.
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SOURCE Virax BioLabs Group Limited
FAQ
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