Tonix Pharmaceuticals stock halted ahead of FDA approval news
WESTON, Fla. - ZyVersa Therapeutics, Inc. (NASDAQ:ZVSA), a micro-cap biotech company with a market value of $3.22 million, announced Tuesday that its investigational drug VAR 200 has received FDA authorization for Emergency Compassionate Use in a patient with ApoCII amyloidosis, an ultra-rare kidney condition. According to InvestingPro data, the company maintains a solid cash position relative to debt, though its overall Financial Health Score stands at FAIR.
The patient, who continues to show kidney disease progression despite standard renal therapies, will receive treatment at the University of Miami Peggy and Harold Katz Family Drug Discovery Center under the care of Dr. Alessia Fornoni, the inventor of VAR 200. For investors tracking breakthrough medical treatments, InvestingPro offers comprehensive analysis of biotech companies, including 10+ additional insights about ZVSA’s financial position and growth prospects.
ApoCII amyloidosis causes abnormal deposition of toxic fibrillar amyloid proteins in organs, primarily affecting the kidneys and leading to protein spillage in urine and chronic kidney disease. Dr. Fornoni hypothesized that VAR 200 could help alleviate lipid accumulation based on the patient’s kidney biopsy showing lipid deposition.
"The evidence of lipotoxic glomerular injury in this patient is what prompted me to request emergency compassionate use," said Dr. Fornoni, Professor of Medicine at the University of Miami Miller School of Medicine. "I believe experimental treatment cases like this one will drive further clinical development for other patients as well."
VAR 200, currently in a Phase 2a clinical trial for diabetic kidney disease, is designed to reduce renal lipid accumulation to protect against kidney injury and improve function. The treatment will follow the protocol of ZyVersa’s ongoing clinical trial.
Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President, stated that the company hopes VAR 200 will "help to improve the course of her disease and quality of life."
Emergency Compassionate Use provides access to investigational drugs outside clinical trials when patients have serious conditions and no comparable treatment options.
The information in this article is based on a company press release.
In other recent news, ZyVersa Therapeutics has activated its first clinical site for a Phase 2a study of VAR 200, a potential treatment for diabetic kidney disease. The study, taking place at the Clinical Advancement Center in San Antonio, Texas, aims to evaluate the efficacy and safety of VAR 200. Preliminary data is expected in 2025, with final results anticipated in 2026. Additionally, ZyVersa has entered into a $10 million share purchase agreement with Williamsburg Venture Holdings, allowing the company to fund further development of VAR 200. This agreement gives ZyVersa the discretion to sell common stock at discounted prices over a 24-month period.
Furthermore, ZyVersa announced promising results from a study on IC 100, its Inflammasome ASC Inhibitor, as a potential treatment for Parkinson’s Disease. The study, supported by the Michael J. Fox Foundation, suggests IC 100 could play a role in reducing inflammation associated with the disease. ZyVersa is also advancing IC 100 as a complementary therapy for obesity-related cardiometabolic issues, with plans to begin a preclinical study in 2025. The company aims to initiate a Phase 1 clinical trial for IC 100 in early 2026. These developments highlight ZyVersa’s ongoing efforts in addressing unmet medical needs in both renal and inflammatory diseases.
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