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On Wednesday, Benchmark analysts reiterated their Speculative Buy rating and a $3.00 price target for Unicycive Therapeutics (NASDAQ:UNCY) stock, which currently has a market capitalization of approximately $72 million. According to InvestingPro data, analyst consensus remains strongly bullish with price targets ranging from $3.00 to $9.00 per share. The company is currently awaiting the U.S. Food and Drug Administration (FDA) approval for its leading product candidate, Oxylanthanum Carbonate (OLC), which is expected later this year. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of June 28, 2025, for OLC, which is intended to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
OLC, a phosphate binder, is designed with a proprietary nanoparticle formulation that allows for a reduced daily pill burden. Patients would only need to swallow three pills a day instead of the up to twelve chewable tablets currently prescribed in other treatments. This improvement could lead to better patient compliance and potentially improved outcomes for an estimated 500,000 U.S. patients undergoing treatment for hyperphosphatemia.
The company’s efforts are also aimed at having OLC included in updated quality guidelines due to its more manageable dosing regimen compared to existing therapies. If approved, OLC could be priced similarly to the leading branded drug in the category, Fosrenol (lanthanum carbonate), which costs around $14,000 for an annual course of treatment. This positions OLC in a potential market worth approximately $7 billion. InvestingPro analysis indicates the company’s overall financial health score is currently weak, with particularly concerning metrics in profitability and cash flow management.
Unicycive concluded the quarter with a cash balance of $19.8 million, which is expected to fund the company’s operations until it reaches its next development milestone. While the company maintains more cash than debt on its balance sheet, InvestingPro analysis reveals rapid cash burn with negative free cash flow of $31.1 million in the last twelve months. Benchmark’s report highlighted no changes to their forward estimates or the Speculative Buy rating for Unicycive’s stock. Subscribers to InvestingPro can access 6 additional key insights about UNCY’s financial health and growth prospects.
In other recent news, Unicycive Therapeutics has been in the spotlight with significant developments. The company recently presented new data at the National Kidney Foundation Spring Clinical Meetings, showcasing its oxylanthanum carbonate (OLC) treatment for hyperphosphatemia in chronic kidney disease patients. This data highlighted a reduced pill burden, potentially enhancing patient adherence to the treatment regimen. Analysts at H.C. Wainwright maintained their Buy rating and raised the price target to $7.50, reflecting confidence in Unicycive’s market performance. Additionally, Benchmark analyst Brice Jackson maintained a Speculative Buy rating with a $3.00 price target, noting the company’s anticipation of FDA approval for OLC later this year. Unicycive’s New Drug Application for OLC has been accepted, with a critical Prescription Drug User Fee Act decision date set for June 28, 2025. The company is preparing for a potential commercial launch of OLC in late 2025, aiming to position it competitively in a market valued at $7 billion. The focus on reducing the pill burden with OLC may improve patient compliance compared to existing treatments. These developments underscore Unicycive’s strategic advancements in the hyperphosphatemia treatment landscape.
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