IPO Year: 2022
Exchange: NASDAQ
4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)
4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)
4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)
4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)
4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)
4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)
4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)
SC 13G/A - ZyVersa Therapeutics, Inc. (0001859007) (Subject)
10-Q - ZyVersa Therapeutics, Inc. (0001859007) (Filer)
DEFA14A - ZyVersa Therapeutics, Inc. (0001859007) (Filer)
DEF 14A - ZyVersa Therapeutics, Inc. (0001859007) (Filer)
EFFECT - ZyVersa Therapeutics, Inc. (0001859007) (Filer)
PRE 14A - ZyVersa Therapeutics, Inc. (0001859007) (Filer)
8-K - ZyVersa Therapeutics, Inc. (0001859007) (Filer)
S-3 - ZyVersa Therapeutics, Inc. (0001859007) (Filer)
10-K - ZyVersa Therapeutics, Inc. (0001859007) (Filer)
8-K - ZyVersa Therapeutics, Inc. (0001859007) (Filer)
S-8 - ZyVersa Therapeutics, Inc. (0001859007) (Filer)
KEY HIGHLIGHTS First patient expected to start therapy by end of Q2-2025 in Phase 2a proof-of concept clinical trial for Cholesterol Efflux MediatorTM VAR 200 in patients with diabetic kidney disease (DKD).Obesity-associated cardiometabolic preclinical proof-of-concept study with Inflammasome ASC Inhibitor IC 100 planned to begin by end of Q2-2025.Investigational New Drug Application (IND) for IC 100 anticipated to be submitted H2-2025, followed by initiation of a Phase 1 clinical trial in healthy overweight subjects at risk of cardiometabolic diseases.Groundbreaking data demonstrating IC 100 blocks microglial inflammasome activation and reduces neurotoxic alpha-synuclein accumulation — bot
KEY HIGHLIGHTS: Phase 2a proof-of concept clinical trial for Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease (DKD) expected to begin H1-2025. Regulatory path for VAR 200's lead indication, focal segmental glomerulosclerosis (FSGS), expected to be shorter based on FDA's alignment with data supporting proteinuria reduction as a clinical trial endpoint for approval of FSGS drugs (Parasol Initiative). Obesity proof-of-concept studies with Inflammasome ASC Inhibitor IC 100 in diet-induced obesity (DIO) mouse models are planned to begin H1-2025.Investigational New Drug Application (IND) for IC 100 is anticipated to be submitted H2-2025, followed by initiation
KEY BUSINESS HIGHLIGHTS Phase 2a clinical trial for Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease expected to begin Q1-2025.New Obesity, Metabolic & Inflammatory Disease Scientific Advisory Board (SAB) was formed in October 2024 to support development of Inflammasome ASC Inhibitor IC 100 for obesity with metabolic complications.Two obesity proof-of-concept studies with IC 100 in diet-induced obesity (DIO) mouse models are planned, which will include assessment of various metabolic parameters. At least one of the studies is targeted to begin Q4-2024.IC 100 Investigational New Drug (IND) submission is planned for Q2-2025, and once cleared, will be followed by
KEY HIGHLIGHTS Phase 2a clinical trial for Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease on track to begin H2-2024.Obesity with related metabolic complications selected as lead indication for Inflammasome ASC Inhibitor IC 100. Supportive data from preclinical study in atherosclerosis, a common obesity-related metabolic complication, is expected to be available H2-2024. IC 100 Investigational New Drug (IND) submission planned for Q4-2024, to be followed by initiation of a Phase 1 clinical trial in obesity with metabolic complications expected to begin Q1-2025.Raised approximately $0.8 million from exercise of investor warrants. WESTON, Fla., Aug. 09, 2024 (
Key Highlights: Second research site selected to enhance enrollment in the Phase 2a clinical trial for Cholesterol Efflux MediatorTM VAR 200 in patients with diabetic kidney disease planned to begin H1-2024.GLP toxicology studies for Inflammasome ASC Inhibitor IC 100 scheduled to begin H1-2024, with planned Investigational New Drug (IND) submission Q4-2024, and Phase 1 clinical trial initiation Q1-2025.Atherosclerosis preclinical data readout for Inflammasome ASC Inhibitor IC 100 on schedule for H1-2024.Initiation of preclinical study to assess Inflammasome ASC Inhibitor IC 100 for obesity-associated metabolic comorbidities scheduled to begin Q2-2024 with completion expected by year's end.R
Key Highlights: Cholesterol Efflux MediatorTM VAR 200 on target to begin Phase 2a clinical trial in patients with diabetic kidney disease H1-2024.Inflammasome ASC Inhibitor IC 100 preclinical program nearing completion, with planned Investigational New Drug (IND) submission Q4-2024, and Phase 1 clinical trial initiation shortly thereafter.Inflammasome ASC Inhibitor IC 100 preclinical research funded by The Michael J. Fox Foundation for Parkinson's Research (MJFF) nearing completion, with potential for a second MJFF grant for further research.Scientific collaboration to assess Inflammasome ASC Inhibitor IC 100 as a potential treatment for atherosclerosis expected to conclude H1-2024.Scientif
Key Corporate Highlights: Progressing toward Q1-2024 initiation of a proof-of-concept clinical trial with Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease (DKD).Granted a European patent covering use of VAR 200 (2-hydroxypropyl-beta-cyclodextrin) in diabetic nephropathy/diabetic kidney disease.Nearing completion of pre-clinical requirements for GLP toxicology studies and subsequent IND submission. WESTON, Fla., Nov. 14, 2023 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (NASDAQ:ZVSA, "ZyVersa"))), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory dise
Key Highlights: Advanced clinical development initiatives for Cholesterol Efflux Mediator™ VAR 200, with planned initiation of a Phase 2a clinical trial in diabetic kidney disease (DKD) in the first quarter of 2024Granted a European patent covering Phase 2a-ready Cholesterol Efflux MediatorTM VAR 200 (2-hydroxypropyl-beta-cyclodextrin) for use in diabetic nephropathy/diabetic kidney diseasePublished new white paper detailing the critical role of inflammasome ASC in inflammatory diseases, and the potential of Inflammasome ASC Inhibitor IC 100 to address multiple CNS and non-CNS diseasesAdded Dr. Douglas Golenbock to ZyVersa's Inflammatory Disease Scientific Advisory Board to support advanc
Key Highlights: Continued progress has been made in advancing an investigator-initiated clinical trial to gain human proof-of-concept for Cholesterol Efflux Mediator™ VAR 200 in patients with renal diseaseAnnounced publication of several peer-reviewed journal articles supporting ASC inhibition as a promising therapeutic target - data continue to demonstrate that multiple types of inflammasomes are activated in various conditions (Alzheimer's disease, traumatic brain injury, and injury from intracortical implants), and substantiate that extracellular release of ASC specks to neighboring cells heighten and perpetuate damaging inflammation leading to disease progression in conditions such as P
Key Highlights: Closed business combination with Larkspur Health Acquisition Corp. in December 2022 and began trading on Nasdaq Global Market under the ticker symbol "ZVSA"Planning underway with nephrologists for an investigator-initiated clinical trial in focal segmental glomerulosclerosis ("FSGS") and up to two other renal populations to gain human proof-of-concept for Cholesterol Efflux Mediator™ VAR 200Recently published data in peer-reviewed journals detail the mechanism of action of inflammasome ASC inhibitor IC 100, and support its CNS activity in preclinical models of aging and Alzheimer's diseaseAdded three new Board members and three new members to Renal Scientific Advisory Board
KEY HIGHLIGHTS First patient expected to start therapy by end of Q2-2025 in Phase 2a proof-of concept clinical trial for Cholesterol Efflux MediatorTM VAR 200 in patients with diabetic kidney disease (DKD).Obesity-associated cardiometabolic preclinical proof-of-concept study with Inflammasome ASC Inhibitor IC 100 planned to begin by end of Q2-2025.Investigational New Drug Application (IND) for IC 100 anticipated to be submitted H2-2025, followed by initiation of a Phase 1 clinical trial in healthy overweight subjects at risk of cardiometabolic diseases.Groundbreaking data demonstrating IC 100 blocks microglial inflammasome activation and reduces neurotoxic alpha-synuclein accumulation — bot
WESTON, Fla., May 07, 2025 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (NASDAQ:ZVSA), a clinical-stage biopharmaceutical company specializing in first-in-class therapies for inflammatory and renal diseases, announces significant developments for Inflammasome ASC Inhibitor IC 100. CEO Stephen C. Glover issued a shareholder letter detailing the company's strategy to position IC 100 as a complementary therapy to GLP-1 agonists to treat obesity-associated cardiometabolic complications. Obesity: A Global Health Crisis with Unmet Medical Needs Obesity has reached pandemic proportions, affecting over 40% of Americans, with a projected increase to 51% of the global population within 12 years
KEY HIGHLIGHTS: Phase 2a proof-of concept clinical trial for Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease (DKD) expected to begin H1-2025. Regulatory path for VAR 200's lead indication, focal segmental glomerulosclerosis (FSGS), expected to be shorter based on FDA's alignment with data supporting proteinuria reduction as a clinical trial endpoint for approval of FSGS drugs (Parasol Initiative). Obesity proof-of-concept studies with Inflammasome ASC Inhibitor IC 100 in diet-induced obesity (DIO) mouse models are planned to begin H1-2025.Investigational New Drug Application (IND) for IC 100 is anticipated to be submitted H2-2025, followed by initiation
In obesity-associated cardiomyopathy (OAC), heart muscle is structurally and functionally abnormal, impairing the ability to effectively pump blood. Five-year survival rate is less than 50%, with congestive heart failure and sudden cardiac death predominant causes of death.Data showed that NLRP3 inflammasome inhibition attenuated inflammation, heart muscle enlargement and fibrosis, and improved heart function.Data support the potential of ZyVersa's Inflammasome ASC Inhibitor IC 100 as an effective treatment option for patients with obesity and its associated cardiovascular comorbidities. WESTON, Fla., March 18, 2025 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (NASDAQ:ZVSA, or "Zy
Alzheimer's disease (AD), affecting around 6.9 million people in the US, is ranked as the seventh leading cause of death and is the most common cause of dementia among older adults.AD begins with buildup of amyloid beta (Aβ) plaques and neurofibrillary tangles in the brain that causes brain cells to die over time and the brain to shrink.The data demonstrate that initial deposition of Aβ triggers NLRP3 inflammasome activation causing release of ASC specks which rapidly enhance aggregation of Aβ. Aβ aggregates also activate NLRP3 inflammasomes thus triggering an ongoing cycle of IL-1β and ASC-mediated inflammation and Aβ deposition in the brain leading to AD progression. NLRP3 Inflammasome inh
WESTON, Fla., March 06, 2025 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (NASDAQ:ZVSA, or "ZyVersa")), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, today announced that it has entered into a securities purchase agreement with a single healthcare-focused U.S. institutional investor for the purchase and sale of 2,105,265 shares of common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to 2,105,265 shares of common stock at an effective combined price of $0.95 per share and common warrant for aggregate gross proceeds of approximately $2.0 million, before deducting place
Heart failure with preserved ejection fraction (HFpEF), a chronic inflammatory condition, is a leading cause of morbidity and mortality globally. Obesity, diabetes, and hypertension are highly prevalent in this population and usually precede HFpEF development.Authors of the published data report that the cardioprotective effects and improvements in metabolic parameters with inflammasome inhibition were correlated with reduced inflammation and macrophage activation in both cardiac and visceral adipose tissue.These data support the potential of ZyVersa's Inflammasome ASC Inhibitor IC 100 as an effective treatment option for patients with obesity and its associated cardiovascular and metabolic
Strokes affect 795,000 people annually in the US. Obesity, a top risk factor for strokes, is associated with around one out of five strokes.Cardiac complications following a stroke are a leading cause of mortality and morbidity, second only to acute neurological injury.The pathomechanism underlying cardiac dysfunction following a stroke includes a surge of catecholamines, such as epinephrine, which induces inflammasome activation triggering a systemic inflammatory response.The published data showed that following a stroke, Inflammasome ASC Inhibitor IC 100 blocked AIM2 inflammasome activation and cell death (pyroptosis) in the heart and improved cardiac function.Data from this article suppor
KEY BUSINESS HIGHLIGHTS Phase 2a clinical trial for Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease expected to begin Q1-2025.New Obesity, Metabolic & Inflammatory Disease Scientific Advisory Board (SAB) was formed in October 2024 to support development of Inflammasome ASC Inhibitor IC 100 for obesity with metabolic complications.Two obesity proof-of-concept studies with IC 100 in diet-induced obesity (DIO) mouse models are planned, which will include assessment of various metabolic parameters. At least one of the studies is targeted to begin Q4-2024.IC 100 Investigational New Drug (IND) submission is planned for Q2-2025, and once cleared, will be followed by
During obesity, inflammasome-driven inflammation results in significant loss of pancreatic islet beta cell mass, severely impairing the insulin secreting capacity of the remaining beta cells.Preserving pancreatic islet beta cell function is key to prevention of insulin resistance and development of type 2 diabetes.The published data showed that inflammasome NLRP3 inhibition was protective of pancreatic islet beta cells, restoring their function and improving metabolic status in an obesity DIO mouse model.Data from this article support ZyVersa's development of Inflammasome ASC Inhibitor IC 100 for obesity and its associated comorbidities to be used as an add-on to incretin therapy. WESTON, F