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On Thursday, Benchmark analyst Brice Jackson maintained a Speculative Buy rating and a $3.00 price target on Unicycive Therapeutics (NASDAQ:UNCY) shares, which currently trades at $0.52. According to InvestingPro data, the stock has experienced significant volatility, with a 43% gain over the past six months despite a recent 13% weekly decline. Jackson's reiteration follows the company's anticipation of FDA approval for its first product candidate, Oxylanthanum Carbonate (OLC), expected later this year.
Unicycive Therapeutics announced in November that the FDA had accepted its New Drug Application (NDA) for OLC, aimed at treating hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis. With a market capitalization of $61 million, the company is rapidly developing its pipeline despite challenging financial metrics revealed by InvestingPro, including negative EBITDA of -$32 million. The Prescription Drug User Fee Act (PDUFA) date for a decision on OLC is set for June 28, 2025. OLC is designed as a phosphate binder that uses a proprietary nanoparticle formulation, allowing for a reduced pill intake of three tablets daily, which are swallowed rather than chewed.
OLC's lower daily pill burden is intended to improve patient compliance compared to current treatments, which may require up to 12 chewable tablets a day. This aspect of the treatment could lead to better outcomes for the estimated 500,000 patients in the United States currently receiving therapy for hyperphosphatemia.
Unicycive Therapeutics is also working to have OLC included in updated quality guidelines, given its potential advantages over existing treatments. The company believes that OLC could be priced comparably to the leading branded drug in the category, Fosrenol (lanthanum carbonate), which costs approximately $14,000 for an annual course of treatment. This positions OLC in a market with a potential value of $7 billion.
In other recent news, Unicycive Therapeutics has garnered attention with several notable developments. The company is preparing for a significant regulatory milestone with the Prescription Drug User Fee Act (PDUFA) date set for June 28, 2025, for its New Drug Application (NDA) for oxylanthanum carbonate (OLC). H.C. Wainwright has maintained a Buy rating on Unicycive and raised the price target to $7.50 from $4.00, citing the anticipated commercial launch of OLC and upcoming milestones as key factors. Preclinical data published in Kidney360 suggests that a combination of OLC and tenapanor could enhance phosphate management in dialysis patients, potentially addressing unmet needs in hyperphosphatemia treatment.
Unicycive is pursuing FDA approval for OLC through the 505(b)(2) regulatory pathway, supported by clinical and preclinical data. The company highlights the challenges faced by kidney disease patients with current phosphate management therapies, emphasizing the potential benefits of OLC's smaller pill size and lower burden. Additionally, Unicycive is developing UNI-494 for acute kidney injury, which has completed a Phase 1 trial. The global market for hyperphosphatemia treatments is substantial, with North America accounting for a significant portion, underscoring the need for improved therapeutic options.
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