LOS ALTOS, Calif. - Unicycive Therapeutics, Inc. (NASDAQ: UNCY), a clinical-stage biotechnology company, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its drug candidate Oxylanthanum Carbonate (OLC). The submission, made on Tuesday, aims to secure approval for OLC's use in treating hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
OLC, which utilizes proprietary nanoparticle technology, is designed to control phosphate levels while potentially reducing the number of pills patients currently need to take. This lower pill burden could improve patient adherence to treatment regimens, addressing a significant unmet need identified by nephrologists.
The NDA is supported by data from three clinical studies involving healthy volunteers and CKD patients on dialysis, as well as preclinical studies and manufacturing specifications. Unicycive's CEO, Dr. Shalabh Gupta, expressed optimism about the prospects of OLC, highlighting the company's efforts to reach this regulatory milestone and preparations for the drug's potential launch.
The FDA has granted a waiver for the Prescription Drug User Fee Act (PDUFA) fees associated with the NDA, saving Unicycive approximately $4 million. OLC's development is protected by over forty issued and granted patents globally.
Hyperphosphatemia is a common and serious condition in patients with end-stage renal disease (ESRD), leading to complications such as bone disease and cardiovascular issues. Despite existing treatments, many patients do not achieve recommended phosphorus levels.
The global market for hyperphosphatemia treatment is expected to surpass $2.5 billion, with the U.S. market accounting for a significant portion. Unicycive, which also has another drug candidate for acute kidney injury in its pipeline, aims to address this substantial market opportunity.
This news is based on a press release statement from Unicycive Therapeutics, Inc. The company's forward-looking statements are subject to various risks, including the uncertainties of clinical trials and regulatory approval processes.
In other recent news, Unicycive Therapeutics continues to make strides in its clinical trials. The company has confirmed its plan to submit a New Drug Application (NDA) for oxylanthanum carbonate (OLC) by the end of August 2024. This follows positive topline data from its pivotal clinical trial of OLC, which reported favorable safety and tolerability endpoints. Unicycive has also secured a U.S. patent for its compound, UNI-494, which is currently undergoing a Phase 1 clinical trial in the United Kingdom.
Despite these positive developments, Unicycive has been notified by the Nasdaq Stock Market about potential delisting due to not meeting the minimum bid price requirement. In response, the company has doubled its authorized shares from 200 million to 400 million. H.C. Wainwright, Noble Capital, and Piper Sandler have maintained their positive ratings for Unicycive, with the expectation for top-line data from a 16-week Phase 2 trial evaluating OLC's tolerability in 2024. These are the recent developments in Unicycive Therapeutics' journey.
InvestingPro Insights
As Unicycive Therapeutics, Inc. (NASDAQ: UNCY) positions itself in the hyperphosphatemia treatment market with its recent New Drug Application, investors and stakeholders are closely monitoring the company's financial health and market performance. According to InvestingPro data, Unicycive currently holds a market capitalization of $31.87 million. However, the company's P/E ratio stands at -0.49, reflecting challenges in profitability, which is further evidenced by a negative adjusted P/E ratio over the last twelve months as of Q2 2024.
InvestingPro Tips reveal that Unicycive has more cash than debt on its balance sheet, indicating a degree of financial flexibility. Moreover, four analysts have revised their earnings upwards for the upcoming period, suggesting potential optimism about the company's prospects. Yet, it's important to note that Unicycive is quickly burning through cash and suffers from weak gross profit margins, which could be cause for concern among investors. Additionally, the stock price has experienced considerable volatility, with a significant decline of 62.73% over the last three months and 78.89% over the last six months as of the same period.
These financial metrics and InvestingPro Tips are especially relevant as Unicycive prepares for the potential market entry of OLC. The company's financial stability and market sentiment could impact its ability to successfully commercialize the drug, should it receive FDA approval. For readers interested in a deeper analysis, there are additional InvestingPro Tips available, which provide a comprehensive look at Unicycive's financial and market performance. Visit https://www.investing.com/pro/UNCY for more detailed insights.
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