On Friday, Benchmark maintained a Speculative Buy rating on Unicycive Therapeutics (NASDAQ: UNCY) with a steady price target of $3.00. The firm's analyst highlighted Unicycive's recent submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Oxylanthanum Carbonate (OLC), a treatment for hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
OLC, a phosphate binder, is designed to reduce the daily pill burden for patients, requiring only three pills per day that are swallowed rather than chewed. This could lead to better patient compliance and improved outcomes for the estimated 500,000 U.S. patients currently being treated for hyperphosphatemia. The current standard treatments require patients to take up to 12 chewable tablets daily.
The study results released in June demonstrated a low discontinuation rate, with only 5 out of 86 subjects (6%) stopping the treatment, and two of these cases were unrelated to the drug. This rate is notably lower than the 14% discontinuation rate for Fosrenol, as mentioned in its package insert.
The analyst suggested that due to the improved dosing regimen and potential for higher treatment adherence, OLC could achieve pricing comparable to Fosrenol, the leading branded drug in the category, which costs approximately $14,000 for an annual course of treatment. This implies a potential market of $7 billion.
In conclusion, Benchmark's analyst reported that the firm is updating its model for the second quarter filings without altering its forward expectations for Unicycive Therapeutics.
In other recent news, Unicycive Therapeutics has submitted a New Drug Application (NDA) for Oxylanthanum Carbonate (OLC), a treatment for hyperphosphatemia in chronic kidney disease patients on dialysis. This submission has been backed by data from three clinical studies and additional preclinical data.
Unicycive has also secured a U.S. patent for UNI-494, a compound aimed at treating acute kidney injury. Despite these advancements, Unicycive faces potential delisting from the Nasdaq Market due to non-compliance with the exchange's listing rules. H.C. Wainwright, Noble Capital, and Piper Sandler have maintained their positive ratings for Unicycive, with H.C. Wainwright adjusting its stock price target to $2.50.
InvestingPro Insights
As Unicycive Therapeutics (NASDAQ: UNCY) awaits the FDA's decision on its New Drug Application for OLC, investors are closely monitoring the company's financial health and market performance. According to InvestingPro, Unicycive holds more cash than debt on its balance sheet, which could provide some stability as it navigates the costly drug approval process. However, the company is also quickly burning through cash, a point of concern that investors should consider.
Market sentiment appears cautious, with Unicycive's stock price experiencing significant volatility and a notable decline over the last six months. Analysts have revised their earnings upwards for the upcoming period, suggesting some optimism surrounding the company's prospects. Yet, it's important to note that analysts do not anticipate the company to be profitable this year, and the stock does not pay a dividend to shareholders.
InvestingPro data shows a market cap of $33.34 million, with a negative P/E ratio, reflecting the company's current lack of profitability. The revenue growth for the last twelve months as of Q2 2024 stands at -100%, indicating challenges in generating sales. With the next earnings date set for November 12, 2024, investors will be looking for signs of improvement in operating income and other financial metrics.
For those interested in a deeper analysis, InvestingPro offers additional tips on Unicycive Therapeutics, which can be accessed through their platform. These insights may provide valuable context for investors as they assess the potential risks and rewards associated with this speculative biotech investment.
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