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WESTON, Fla. - ZyVersa Therapeutics, Inc. (NASDAQ:ZVSA), a biopharmaceutical company focused on developing drugs for renal and inflammatory diseases with a current market capitalization of $1.49 million, has shared updates in a shareholder letter from CEO Stephen C. Glover about their drug VAR 200 and its development for Focal Segmental Glomerulosclerosis (FSGS). According to InvestingPro data, the company's stock has experienced significant volatility, declining 92% over the past year, though analysts maintain a $20 price target, suggesting potential upside from current levels. The company is leveraging the recent PARASOL recommendations, which may streamline the approval process for FSGS treatments by using proteinuria reduction as a surrogate endpoint. While InvestingPro analysis indicates the company maintains more cash than debt on its balance sheet, it currently faces challenges with short-term obligations exceeding liquid assets, reflected in a current ratio of 0.15.
ZyVersa is initiating a Phase 2a proof-of-concept trial for VAR 200 in Diabetic Kidney Disease (DKD) patients in the first half of this year, aiming to gather early human renal data. Insights from this study will inform the protocol design for a subsequent larger trial in FSGS patients. FSGS is a rare and severe kidney disorder that affects approximately 40,000 people in the U.S. and often leads to kidney failure. Currently, there are no approved drugs that effectively prevent or delay the progression of FSGS to kidney failure.
The PARASOL initiative, a collaboration between kidney disease experts and the FDA, has recommended using a reduction in proteinuria over 24 months as a surrogate endpoint for regulatory approval of FSGS drugs. This recommendation is based on data from over 25 studies and more than 1,600 patients. It is expected to allow for shorter clinical trials with fewer patients to demonstrate drug efficacy.
Travere Therapeutics is likely to be the first beneficiary of these recommendations, having filed a supplemental New Drug Application (sNDA) for Filspari (sparsentan) for FSGS treatment on March 17, 2025, with FDA approval anticipated in the third quarter and a launch expected by the end of the year.
ZyVersa is optimistic about the potential approval of Filspari, as it would validate proteinuria as the primary endpoint for VAR 200's FSGS clinical trials. VAR 200, which targets a unique pathway in the development and progression of FSGS and other kidney diseases, is planned to be used as an add-on therapy to Filspari and other standard care drugs.
The global drug market for kidney diseases was valued at $18 billion in 2024, with projections reaching $30 billion by 2034. The high economic burden of kidney failure treatments, which amounted to an estimated $28 billion for dialysis care and $3.4 billion for transplant patient care in 2023, underscores the urgent need for effective therapies. With an overall Financial Health score of "FAIR" according to InvestingPro, ZyVersa faces both opportunities and challenges in this expanding market. InvestingPro subscribers have access to 12 additional key insights about ZyVersa's financial position and market potential.
This update is based on a press release statement from ZyVersa Therapeutics.
In other recent news, ZyVersa Therapeutics, Inc. has announced a change in its certifying accountant, with CBIZ CPAs P.C. taking over from Marcum LLP. This transition follows CBIZ CPAs' acquisition of Marcum's attest business, approved by ZyVersa's Audit Committee. The company reported that financial statements from Marcum did not contain adverse opinions but included explanatory paragraphs regarding the company's going concern status. Additionally, ZyVersa has published new data indicating that its Inflammasome ASC Inhibitor IC 100 may be effective in treating obesity-associated cardiomyopathy and Alzheimer's disease. The studies suggest that IC 100 can reduce inflammation and improve metabolic functions in both conditions. ZyVersa has also secured $2 million in funding through a financing agreement with a U.S. institutional investor to support its drug development efforts. Furthermore, recent studies have shown IC 100's potential in treating heart failure with preserved ejection fraction, with promising results in reducing cardiac inflammation and improving metabolic parameters. These developments reflect ZyVersa's ongoing commitment to advancing treatments for inflammatory and renal diseases.
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