ZyVersa Therapeutics Inc Stock Price, News & Analysis

ZyVersa Therapeutics (NASDAQ:ZVSA) has received FDA authorization for Emergency Compassionate Use of its Cholesterol Efflux Mediator™ VAR 200 in a patient with ApoCII amyloidosis, an ultra-rare kidney condition. The treatment will be administered at the University of Miami under the care of Dr. Alessia Fornoni, who is also the inventor of VAR 200.

The patient, who has shown continued kidney disease progression despite standard treatments, will receive VAR 200 following the protocol of the ongoing Phase 2a diabetic kidney disease (DKD) clinical trial. The drug was selected due to evidence of lipid deposition in the patient's kidney biopsy and VAR 200's demonstrated ability to reduce renal lipid accumulation in preclinical studies.

ZyVersa Therapeutics (NASDAQ: ZVSA) has activated its first clinical site for patient recruitment in a Phase 2a clinical trial of VAR 200, a potential first-in-class treatment for Diabetic Kidney Disease (DKD). The trial will be conducted at the Clinical Advancement Center in San Antonio, Texas, led by Dr. Pablo Pergola.

VAR 200 is designed to target renal lipotoxicity, a neglected pathogenic pathway in kidney disease that currently has no available treatments. The 16-week open-label study will evaluate VAR 200's efficacy and safety in patients with type 2 diabetes and DKD with proteinuria. Preliminary data is expected in H2-2025, with final results in H2-2026.

The drug has shown promising preclinical results in three types of kidney disease, demonstrating reduced cholesterol levels, protection against renal injury, and improved proteinuria.

ZyVersa Therapeutics (Nasdaq: ZVSA) has secured a share purchase agreement with Williamsburg Venture Holdings for up to $10 million to fund clinical development of its Cholesterol Efflux Mediator™ VAR 200 for chronic kidney diseases. The 24-month agreement allows ZyVersa to sell common stock to WVH at market-discounted prices, with ZyVersa maintaining full control over timing and amount of sales.

The agreement includes a 2.5% commitment share issuance to WVH based on purchased amounts. The funding aims to support VAR 200's development in the kidney disease market, which is projected to grow from $18 billion in 2024 to $30 billion by 2034.

ZyVersa Therapeutics (NASDAQ: ZVSA) highlights a new study published in Nature's Experimental and Molecular Medicine that reinforces the role of microglia-driven inflammation in Parkinson's and Alzheimer's diseases. The study validates ZyVersa's recent research showing how their Inflammasome ASC Inhibitor IC 100 could potentially modify disease progression by inhibiting NLRP1 inflammasome activation and reducing toxic phosphorylated alpha-synuclein levels. The global Parkinson's treatment market, currently valued at $6.6 billion (2024), is projected to reach $13.3 billion by 2034. The research, funded by the Michael J. Fox Foundation and conducted at the University of Miami School of Medicine, demonstrated that inflammatory microglia triggered pathological features of neurodegenerative diseases, including abnormal protein accumulation and neuroinflammation. ZyVersa plans to initiate proof-of-concept studies in Parkinson's disease animal models later this year.

ZyVersa Therapeutics (NASDAQ: ZVSA) reported Q1 2025 financial results and pipeline updates. The company posted a net loss of $2.3M, showing a 20.2% improvement from Q1 2024. Key developments include: 1) Phase 2a trial for VAR 200 in diabetic kidney disease to begin by Q2-end 2025; 2) Obesity-related preclinical study for IC 100 planned for Q2-end 2025; 3) IND application for IC 100 expected in H2 2025. The company raised $2.0M in Q1 but reports only $1.6M cash on hand, requiring additional financing for operations. R&D expenses decreased 49.5% to $259K, while G&A expenses dropped 18.5% to $1.9M. Recent data showed IC 100's potential in treating Parkinson's disease by blocking microglial inflammasome activation and reducing alpha-synuclein accumulation.

ZyVersa Therapeutics (NASDAQ: ZVSA) has announced strategic developments for its Inflammasome ASC Inhibitor IC 100, positioning it as a complementary therapy to GLP-1 agonists for treating obesity-related complications. The company highlights that while GLP-1 agonists are effective for weight loss, significant challenges remain, including muscle loss (20-40%) and high discontinuation rates (65% within one year). IC 100's preclinical data shows promise in reducing inflammation and improving metabolic parameters when combined with GLP-1 agonists. Key advantages include preserved lean mass, enhanced weight loss, and continued benefits after GLP-1 discontinuation. ZyVersa's development timeline includes initiating a preclinical study in H1-2025, submitting an IND application in H2-2025, and beginning Phase 1 trials in H1-2026. The global obesity crisis affects over 40% of Americans, with related costs projected to exceed $4.32 trillion annually by 2035.

ZyVersa Therapeutics announces breakthrough data for their Inflammasome ASC Inhibitor IC 100 in treating Parkinson's Disease (PD). The study, published in npj Parkinson's Disease and supported by the Michael J. Fox Foundation, shows IC 100's potential to slow PD progression.

Key findings demonstrate that IC 100 effectively blocks microglial inflammasome activation and reduces neurotoxic alpha-synuclein accumulation - two major factors in PD progression. The research, conducted at the University of Miami Miller School of Medicine, reveals the first evidence linking ASC speck assembly, NLRP1 inflammasome activation, and alpha-synuclein aggregation in PD patients' neurons.

The global PD drug market, valued at $6.6 billion in 2024, is projected to reach $13.3 billion by 2034. Unlike current treatments that only address symptoms, IC 100 shows promise as a disease-modifying therapy. ZyVersa plans to begin proof-of-concept animal studies later this year.

ZyVersa Therapeutics (NASDAQ: ZVSA) has issued a shareholder letter highlighting key developments in inflammasome inhibitor research and their IC 100 program. The global anti-inflammatory biologics market, valued at $105 billion in 2024, is projected to reach $186 billion by 2034.

The company's IC 100, an Inflammasome ASC Inhibitor, is being developed for chronic inflammatory diseases, focusing initially on obesity-associated cardiometabolic conditions. Key upcoming milestones include:

• Proof-of-concept study in diet-induced obesity mouse model starting H1-2025
• IND submission planned for H2-2025
• Phase 1 clinical trial initiation in overweight subjects following IND approval
• Completion of preclinical study for Parkinson's disease treatment, funded by The Michael J. Fox Foundation

ZyVersa Therapeutics (NASDAQ: ZVSA) announces significant developments regarding their drug VAR 200 for Focal Segmental Glomerulosclerosis (FSGS). The PARASOL initiative's recent recommendations are expected to streamline FSGS drug development by accepting proteinuria reduction over 24 months as a surrogate endpoint for regulatory approval, replacing the need for long-term kidney failure outcomes.

The company plans to initiate a Phase 2a proof-of-concept trial for VAR 200 in Diabetic Kidney Disease (DKD) patients in the first half of 2025, before proceeding with FSGS trials. This strategic approach aims to gather preliminary human renal data and optimize future FSGS study protocols.

FSGS affects approximately 40,000 people in the US and currently has no approved drug therapies. The global kidney disease drug market reached $18 Billion in 2024 and is projected to reach $30 Billion by 2034. VAR 200, targeting cholesterol accumulation in kidney filtration systems, is positioned as an add-on therapy to existing treatments.