ZyVersa Therapeutics CEO Issues Shareholder Letter on PARASOL Recommendations Expected to Reduce Drug Development Barrier for Rare Kidney Disease, Focal Segmental Glomerulosclerosis (FSGS)
WESTON, Fla., April 08, 2025 (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 diseases who have unmet medical needs, announces that Stephen C. Glover, Co-Founder, Chairman, Chief Executive Officer, and President, has issued a Shareholder Letter addressing the recent PARASOL recommendations expected to shorten drug development time and approval for rare kidney disease, FSGS. The full text of the letter follows.
A MESSAGE FROM OUR CHIEF EXECUTIVE OFFICER
ZyVersa is developing Cholesterol Efflux Mediator™ VAR 200 for treatment of chronic kidney diseases, initially focusing on FSGS as the lead. Plans for indication expansion include treatments for Alport Syndrome and Diabetic Kidney Disease. The global drug market for kidney diseases was $18 Billion in 2024, with $30 Billion projected by 2034 (Precedence Research).
Today, I am thrilled to update you on a recent advancement that is expected to be a giant step forward in FSGS drug development and anticipated to derisk development of VAR 200 for its lead indication, FSGS. Prior to conducting Phase 2 clinical trials in FSGS, we are initiating a small Phase 2a proof-of-concept trial with VAR 200 in the first half of this year in patients with DKD. The intent of the study is to quickly obtain first in human renal data prior to initiating a larger phase 2a/b trial in patients with FSGS. The DKD data will also provide insights to help optimize protocol design for the subsequent FSGS study.
FSGS is a devastating, progressive, and complex rare kidney disorder affecting around 40,000 people in the US. It is a leading cause of kidney failure, requiring dialysis and transplant for survival. With FSGS, it is common for patients to need more than one kidney transplant since the disease can affect the new kidney in a relatively short period of time. FSGS has an overwhelming negative impact on daily living and quality of life. Disease symptoms, such as fatigue and chronic severe swelling, and the number of required drugs and their side effects interfere with daily activities. It is common for patients to miss a large percentage of school or work days making it challenging to graduate or hold a job. Likewise, patients, especially children, are often hospitalized missing holidays and family celebrations, including their own birthdays. Additionally, patients with FSGS experience a substantial degree of anxiety and emotional impact from fear of needing dialysis or transplant, and from concern about exposure to infectious diseases resulting from the immunosuppressive drugs they are on. This leads to social isolation and loneliness. Kidney failure not only affects patients' quality of life but has a high economic burden. In 2023, an estimated $28 billion was spent on dialysis care and $3.4 billion on transplant patient care. To date, there are no approved drug therapies that effectively prevent or delay FSGS progression to kidney failure.
One reason for the lack of drug treatments is the high regulatory hurdle requiring drug developers to demonstrate a substantially reduced FSGS progression to kidney failure. FSGS trials can require decades of follow-up in large study populations to measure kidney failure. This is generally not feasible in clinical trials, especially for rare kidney diseases.
Thanks to the initiative of a multi-stakeholder group of rare kidney disease experts and the FDA to identify a robust surrogate endpoint to replace long-term kidney failure outcomes (the PARASOL initiative), it is expected that shorter clinical trials with fewer patients will be required to demonstrate FSGS drug efficacy. The Parasol group recommended a reduction in proteinuria (spillage of protein into the urine) over 24 months as a surrogate endpoint for full regulatory approval of FSGS drugs. According to Dr. Aliza Thompson, PARASOL's Co-chair and Director of the Cardio-Renal Division at the FDA, 'Data supporting the recommendation came from over 25 studies conducted all over the globe and involved more than 1,600 patients, providing a robust foundation for informed regulatory decisions.'
Travere is likely to be the first company to benefit from the PARASOL group's recommendations. Despite a 50% reduction in proteinuria, FDA previously denied accelerated approval for Filspari (sparsentan) for FSGS because the drug failed to demonstrate a reduced progression to kidney failure (based on surrogate marker eGFR). The recent PARASOL recommendations are expected to pave the way for FSGS approval for Filspari. Following a promising Type C meeting with the FDA in February, Travere filed a supplemental New Drug Application (sNDA) on March 17, 2025, seeking priority review for traditional approval of FILSPARI® for treatment of FSGS. FDA approval is anticipated in the third quarter of this year, with launch by year's end.
In an April 3, 2025 analyst update on Travere, Guggenheim indicated that they believe investors underappreciate the FSGS commercial opportunity, which is substantially larger than that for IgAN. This is based on a higher unmet need for effective FSGS drug therapies since patients progress to kidney failure at twice the rate as IgAN patients, and there are fewer expected competitors reducing price sensitivity. Guggenheim has projected $2 Billion in peak sales for Filspari in FSGS.
We are excited about the potential approval of Filspari for FSGS based on a reduction in proteinuria, as it will further support proteinuria as the primary endpoint for VAR 200's FSGS clinical trials. Because VAR 200 targets a unique pathway leading to development and progression of FSGS and other kidney diseases (accumulation of cholesterol and lipids in the kidney's filtration system), VAR 200 will be used as add on therapy to Filspari and other standard of care drugs such as steroids and calcineurin inhibitors. For more information about Cholesterol Efflux Mediator™ VAR 200, Click Here.
We thank you for your continued support.
Sincerely,
Stephen C. Glover
Co-Founder, Chairman, Chief Executive Officer, and President
ZyVersa Therapeutics
ABOUT ZYVERSA THERAPEUTICS, INC.
ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and peripheral inflammatory diseases. For more information, please visit www.zyversa.com.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management's intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc. ('ZyVersa') uses words such as 'anticipates,' 'believes,' 'plans,' 'expects,' 'projects,' 'future,' 'intends,' 'may,' 'will,' 'should,' 'could,' 'estimates,' 'predicts,' 'potential,' 'continue,' 'guidance,' and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa's expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa's plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa's planned preclinical and clinical trials; the timing of the availability of data from ZyVersa's preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa's plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa's product candidates; ZyVersa's commercialization, marketing and manufacturing capabilities and strategy; ZyVersa's ability to protect its intellectual property position; and ZyVersa's estimates regarding future revenue, expenses, capital requirements and need for additional financing.
New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.
This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.
Karen Cashmere
786-251-9641
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
18 minutes ago
- Yahoo
Why Advanced Micro Devices Stock Moved Higher Today
AMD stock jumped early in today's trading, but it gave up most of its gains as the market focused on risk factors for the tech sector and broader market. Investors are seeing signs that AMD is positioned to rack up wins in the artificial intelligence (AI) processor space. AMD's new AI processor and server products could deliver significant wins, but geopolitical dynamics and other factors could still create volatility for the stock. 10 stocks we like better than Advanced Micro Devices › Advanced Micro Devices (NASDAQ: AMD) stock ended Friday's trading in the green, despite pullbacks following a pop early in the session. The company's share price closed out the day up 1.1%, but it had been up as much as 4.7% earlier in the session. Meanwhile, the S&P 500 (SNPINDEX: ^GSPC) fell 0.2% in the daily session, and the Nasdaq Composite (NASDAQINDEX: ^IXIC) fell 0.5%. Thanks to rising excitement surrounding the company's position in artificial intelligence (AI), AMD stock opened today's trading with a big gain. The company's share price still advanced in the daily session, but it lost some ground as investors weighed new export restrictions for semiconductor technologies and the risk of escalating conflict in the Middle East. AMD stock has seen wild fluctuations over the last couple of years in conjunction with shifting expectations for the company's standing and market opportunity in the AI space. Following the Advancing AI 2025 conference hosted by the hardware specialist last week, market sentiment surrounding the stock has become significantly more bullish. At the conference AMD profiled its recently launched Instinct MI350 graphics processing unit (GPU) and its new server product for data centers. The company also announced that it had entered into a new deal to supply OpenAI with processing hardware, and its indications suggest that it may have also reached a new deal with Amazon. AMD appears to be making some laudable progress in the AI hardware market. While the company may continue to play second fiddle to Nvidia in the high-end data center GPU market, it will likely still have opportunities to score some big wins in the space. On the other hand, AMD stock could see high levels of volatility in the near term. Tech stocks wavered today following news that the Trump administration was implementing new bans on tech exports to China, and the market is also on edge about the possibility that the U.S. could get involved in the conflict between Israel and Iran. So even though AMD's AI growth bets appear to be moving in the right direction, there are other big catalysts that could shape stock performance in the near term. Before you buy stock in Advanced Micro Devices, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Advanced Micro Devices wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $659,171!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $891,722!* Now, it's worth noting Stock Advisor's total average return is 995% — a market-crushing outperformance compared to 172% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of June 9, 2025 John Mackey, former CEO of Whole Foods Market, an Amazon subsidiary, is a member of The Motley Fool's board of directors. Keith Noonan has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Advanced Micro Devices, Amazon, and Nvidia. The Motley Fool has a disclosure policy. Why Advanced Micro Devices Stock Moved Higher Today was originally published by The Motley Fool Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
2 hours ago
- Yahoo
Why Digital Turbine Stock Plummeted Today
Digital Turbine stock saw a massive post-earnings rally on Tuesday, but its share price slipped as the week progressed. Investors took profits on the stock today, and geopolitical risk factors also worked to push its share price lower. Digital Turbine is guiding for strong adjusted EBITDA growth this year, but geopolitical dynamics could create valuation volatility. 10 stocks we like better than Digital Turbine › Digital Turbine (NASDAQ: APPS) stock saw a round of substantial sell-offs Friday. The adtech specialist's share price closed out the daily session down 14.6% amid a 0.3% decline for the S&P 500 index and a 0.6% decline for the Nasdaq Composite index. Following an explosive post-earnings rally for the stock earlier this week, investors sold shares and moved to take profits. In addition to profit-taking action, Digital Turbine stock moved lower due to new restrictions on technology exports and fears that the conflict between Israel and Iran could continue to escalate. Digital Turbine stock had actually been up as much as 1.8% in today's trading, but action on the stock turned bearish as investors reacted to risk factors and took profits on gains posted earlier in the week. The company's share price skyrocketed in Tuesday's trading after it posted better-than-expected quarterly results and forward guidance, but its share price has moved lower in subsequent trading. In addition to profit-taking activities, Digital Turbine stock was pressured by geopolitical dynamics today. The Wall Street Journal published a report today stating that the Trump administration wants to further strengthen export restrictions and prevent companies including Samsung, Taiwan Semiconductor Manufacturing, and SK Hynix from shipping chipmaking technologies to their factories in China. Adding another bearish catalyst, investors moved out of stocks due to the possibility that military strikes between Israel and Iran will intensify and that the U.S. could enter the conflict on behalf of Israel. For the current fiscal year, Digital Turbine is guiding for revenue between $515 million and $525 million -- good for annual growth of roughly 6% at the midpoint of the target range. Meanwhile, non-GAAP (adjusted) earnings before interest, taxes, depreciation, and amortization (EBITDA) are projected to be between $85 million and $90 million -- representing growth of 21% at the midpoint of the guidance range. Digital Turbine's performance outlook became significantly stronger following its quarterly release earlier this week, but there are factors that could cause continued volatility for the stock. The company does most of its business in China, and rising geopolitical tensions present substantial risk factors even though it's not a hardware company. Before you buy stock in Digital Turbine, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Digital Turbine wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $659,171!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $891,722!* Now, it's worth noting Stock Advisor's total average return is 995% — a market-crushing outperformance compared to 172% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of June 9, 2025 Keith Noonan has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Taiwan Semiconductor Manufacturing. The Motley Fool has a disclosure policy. Why Digital Turbine Stock Plummeted Today was originally published by The Motley Fool Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
2 hours ago
- Yahoo
Here's Why Sony (SONY) Fell More Than Broader Market
Sony (SONY) closed at $24.75 in the latest trading session, marking a -4.37% move from the prior day. This move lagged the S&P 500's daily loss of 0.22%. On the other hand, the Dow registered a gain of 0.08%, and the technology-centric Nasdaq decreased by 0.51%. The electronics and media company's shares have seen an increase of 2.17% over the last month, surpassing the Consumer Discretionary sector's loss of 0.1% and the S&P 500's gain of 0.45%. The investment community will be closely monitoring the performance of Sony in its forthcoming earnings report. On that day, Sony is projected to report earnings of $0.23 per share, which would represent a year-over-year decline of 4.17%. For the full year, the Zacks Consensus Estimates project earnings of $1.16 per share and a revenue of $79.87 billion, demonstrating changes of -5.69% and -6.09%, respectively, from the preceding year. It is also important to note the recent changes to analyst estimates for Sony. Such recent modifications usually signify the changing landscape of near-term business trends. As a result, we can interpret positive estimate revisions as a good sign for the business outlook. Empirical research indicates that these revisions in estimates have a direct correlation with impending stock price performance. To utilize this, we have created the Zacks Rank, a proprietary model that integrates these estimate changes and provides a functional rating system. The Zacks Rank system, spanning from #1 (Strong Buy) to #5 (Strong Sell), boasts an impressive track record of outperformance, audited externally, with #1 ranked stocks yielding an average annual return of +25% since 1988. Within the past 30 days, our consensus EPS projection has moved 2.31% lower. Sony is currently a Zacks Rank #5 (Strong Sell). With respect to valuation, Sony is currently being traded at a Forward P/E ratio of 22.26. This signifies a discount in comparison to the average Forward P/E of 33.66 for its industry. Meanwhile, SONY's PEG ratio is currently 12.44. The PEG ratio is similar to the widely-used P/E ratio, but this metric also takes the company's expected earnings growth rate into account. SONY's industry had an average PEG ratio of 12.44 as of yesterday's close. The Audio Video Production industry is part of the Consumer Discretionary sector. With its current Zacks Industry Rank of 193, this industry ranks in the bottom 22% of all industries, numbering over 250. The Zacks Industry Rank is ordered from best to worst in terms of the average Zacks Rank of the individual companies within each of these sectors. Our research shows that the top 50% rated industries outperform the bottom half by a factor of 2 to 1. Make sure to utilize to follow all of these stock-moving metrics, and more, in the coming trading sessions. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sony Corporation (SONY) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
